Association"
}
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"ErrorResponseExample":{
"description":"ErrorResponseExample",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"INVALID_START_TIME",
"errorMessage":"Invalid fromTimestamp in the request url"
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v10.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v10.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v10.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"V10.0",
"description":"Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: LOCKED.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"getBlindedSubjectDataset",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given visit. This field can have the following values: LOCKED: All objects within the visit are currently locked.UNLOCKED: The visit has no locks applied after being locked at one point in the past.null: No lock has ever been applied to this visit.
|
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | VARCHAR2(40) | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Screen01",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"N",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v10.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v10.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v10.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: EHR_ENABLED, EHR_IMPORTED, and SDV_SELECTION_STATUS.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"SDV_SELECTION_STATUS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n EHR_IMPORTED | CHAR(1) | Indicates if a question was populated via an Electronic Health Record (EHR) data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes. Possible values include Y or N. |
\n SDV_SELECTION_STATUS | VARCHAR2(32 CHAR) | Indicates if, after all applicable Source Data Verification (SDV) settings combined, the question requires verification or not for the subject. This is determined based on the study SDV settings, the SDV strategy assigned to the site, whether the subject is part of the pool of selected subjects for SDV, and SDV settings defined at the item level in form design. For more information, see Understand Source Data Verification. This data element is populated with four possible values: OBLIGATORY: the question requires verification. This means that either the study has a 100% SDV configuration or it has a Targeted SDV configuration and the question is selected for SDV for that given subject.
OPTIONAL: the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. OPTIONAL_CRITICAL: the question is set as a critical variable but the subject is not part of the SDV subject pool, hence the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. IRRELEVANT: the question is not configured for SDV for this subject and it is not expected to be verified. This would be the case of:
- Read-only questions.
- Studies set up for no SDV.
- Studies with Targeted SDV configuration that don't allow SDV overrides.
- Screen failed subjects when excluded from SDV.
|
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | Flags rows that describe a missing question or item value. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Indicates the question type as specified by the study designer. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | A number that represents the unique identifier of the item. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | Indicates the current status of the subject in the study. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Indicates the row position of the item. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"SDV_SELECTION_STATUS"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"0",
"0",
"0",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"Central Lab A",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"N",
"N",
"Manual Entry",
"OBLIGATORY",
"OBLIGATORY"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"SDV_SELECTION_STATUS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v10.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v10.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v10.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: FORM_EVENT_TYPE.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n FORM_EVENT_TYPE | VARCHAR2(64) | Indicates the type of event for changes in form status records. This element currently shows events in the restore flow, setting it to FORM_RESTORED when a record was restored after deletion, otherwise it is NULL. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"N",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"Visit_Complete"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v10.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v10.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v10.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: EHR_ENABLED.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n UNBLIND_DATE | TIMESTAMP(6) | Indicates the date and time when the first code break was performed and the subject's treatment arm was unblinded. This value is a timestamp. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date. |
\n UNBLIND_REASON | VARCHAR2(255 CHAR) | Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason. |
\n UNBLIND_COMMENT | VARCHAR2(2048 CHAR) | Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER | Numeric identifier that represents the treatment arm. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS"
],
"data":[
[
"7550C1E7E3CA4B8CAD09ACD1F1E7F580",
"37",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"Tester2",
"United States",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
"10007890",
"2025-10-29T17:00:00.000Z",
"1",
"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"KIT-000457",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"VERIFY_REQUIRED",
"N",
"0",
"Treatment Arm A",
"Arm A dosing schedule",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"DATAHUB_AUT_Site2_Screen13",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N",
"1"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v10.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v10.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v10.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"V10.0",
"description":"Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: SHIPMENT_RCVD_SITE_DEPOT_DATE, SHIPMENT_RECEIVED_BY_WID, SHIPMENT_RECEIVED_BY_ID, SHIPMENT_RECEIVED_BY, and SHIPMENT_RECEIPT_DATE.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblindedKitsDataSetQuery",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RCVD_SITE_DEPOT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"COMPOUNDING_KITS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n FORCED_RAND | CHAR(1) | Indicates whether the subject underwent forced randomization. This helps track how many times forced randomization has been used over the course of the study. This scenario can occur due to a lack of kits for at least one treatment arm in the study at the time of randomization. For this data element, the following values can be displayed: Y: Indicates that a subject underwent forced randomization.N: Indicates that a subject was randomized normally.NULL: Indicates that a subject has not yet been randomized.
|
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n ORDER_TYPE | VARCHAR2(50 CHAR) | Indicates how a shipment was initiated: INITIAL; MANUAL; RESUPPLY |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n SHIPMENT_RECEIPT_DATE | TIMESTAMP(6) | Indicates the date on which the shipment order was received. |
\n SHIPMENT_RCVD_SITE_DEPOT_DATE | TIMESTAMP(6) | Date the shipment was received at the site or depot. |
\n SHIPMENT_RECEIVED_BY | VARCHAR2(255 CHAR) | Indicates the user who confirmed receipt of the shipment order. |
\n COMPOUNDING_KITS | VARCHAR2(1) | Indicates whether a shipment contains compounding kits: Y: the shipment does contain compounding kits. N: the shipment does not contain compounding kits. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n ITEM_NUMBER | VARCHAR2(64 CHAR) | Numeric value used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n MATERIAL_ID | VARCHAR2(64 CHAR) | Alphanumeric identifier of the material of a given kit, used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(1020) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n IS_NON_SERIALIZED_KIT | CHAR(1) | Indicates if the kit is non serialized: Y (Yes) the kit is non-serialized. N (No) the kit is serialized. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER | Numeric identifier of the confirming user. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER | Numeric identifier of the shipment. |
\n SHIPMENT_RECEIVED_BY_ID | RAW(16 BYTE) | GUID of the person who received the shipment. |
\n SHIPMENT_RECEIVED_BY_WID | NUMBER | Numeric identifier of the person who received the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RCVD_SITE_DEPOT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"COMPOUNDING_KITS"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
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"true",
"true",
"true",
"AB1234567",
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"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
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"13",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"Complete",
"DATAHUB_AUT_Site2_Active13",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"19",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"0",
"0",
"1",
"Assigned",
"2025-10-29T17:31:09.030Z",
"MLOT1",
"BLT1",
"MLOT1",
"BLT1",
"2030-12-31T00:00:00.000Z",
"2026-12-31T00:00:00.000Z",
"10",
"0",
"10",
"0",
"9A8B7C6D5E4F4A1B8C7D6E5F4A3B2C1D",
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"2025-10-28T10:00:00.000Z",
"2025-10-28T11:45:00.000Z",
"11223344556677889900AABBCCDDEEFF",
"88",
"2025-10-28T10:15:00.000Z",
"Site Pharmacist",
"TRK123999",
"1",
"Y",
"Week2",
"WEEK2",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"DISPENSATION",
"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
"28",
"0",
"2",
"0",
"2",
"0",
"449CBE4790CF4F66AB58619C86CA405B",
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"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
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"Once Daily",
"0",
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"BLK-0001",
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"N",
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"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
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]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
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"limit":1,
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"columns":[
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"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
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"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RCVD_SITE_DEPOT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"COMPOUNDING_KITS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v10.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v10.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v11.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"V11.0",
"description":"This API is used to extract blinded clinical data (excluding hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds new clinical one extension attribute 'WithdrawalReason , WithdrawalComment, ScreenFailureDate, ScreenFailureComment, ScreenFailureReason and RescreenRepeatKey' at the subject level data. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
},
"example":"Snapshot"
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2023-01-01T00:00:00.000Z"
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2099-01-01T00:00:00.000Z"
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":50
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"ErrorResponseExample":{
"description":"ErrorResponseExample",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"INVALID_START_TIME",
"errorMessage":"Invalid fromTimestamp in the request url"
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v11.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v11.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v11.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"V11.0",
"description":"This API is used to extract unblinded clinical data (including hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds new clinical one extension attribute 'WithdrawalReason , WithdrawalComment, ScreenFailureDate, ScreenFailureComment, ScreenFailureReason and RescreenRepeatKey' at the subject level data. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
},
"example":"Snapshot"
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2023-01-01T00:00:00.000Z"
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2099-01-01T00:00:00.000Z"
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":50
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"ErrorResponseExample":{
"description":"ErrorResponseExample",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"INVALID_START_TIME",
"errorMessage":"Invalid fromTimestamp in the request url"
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v11.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v11.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v11.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"V11.0",
"description":"Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: SDV_SELECTION_VISIT_DATE. It also includes all expected dynamic and branch visits in the missing criteria and modifies the logic for IS_MISSING_VISIT.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"getBlindedSubjectDataset_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"SDV_SELECTION_VISIT_DATE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n SDV_SELECTION_VISIT_DATE | VARCHAR2(32 CHAR) | This element tracks visit dates for visits associated with the record that's part of the targeted SDV pool for a subject tied to the record. The possible values include: OBLIGATORY OPTIONAL OPTIONAL_CRITICAL IRRELEVANT |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given visit. This field can have the following values: LOCKED: All objects within the visit are currently locked.UNLOCKED: The visit has no locks applied after being locked at one point in the past.null: No lock has ever been applied to this visit.
|
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | VARCHAR2(40) | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"SDV_SELECTION_VISIT_DATE"
],
"data":[
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"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Screen01",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"N",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N",
"OBLIGATORY"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"SDV_SELECTION_VISIT_DATE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v11.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v11.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v11.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: DATA_EVENT_TYPE.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"DATA_EVENT_TYPE",
"SDV_SELECTION_STATUS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n EHR_IMPORTED | CHAR(1) | Indicates if a question was populated via an Electronic Health Record (EHR) data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes. Possible values include Y or N. |
\n SDV_SELECTION_STATUS | VARCHAR2(32 CHAR) | Indicates if, after all applicable Source Data Verification (SDV) settings combined, the question requires verification or not for the subject. This is determined based on the study SDV settings, the SDV strategy assigned to the site, whether the subject is part of the pool of selected subjects for SDV, and SDV settings defined at the item level in form design. For more information, see Understand Source Data Verification. This data element is populated with four possible values: OBLIGATORY: the question requires verification. This means that either the study has a 100% SDV configuration or it has a Targeted SDV configuration and the question is selected for SDV for that given subject.
OPTIONAL: the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. OPTIONAL_CRITICAL: the question is set as a critical variable but the subject is not part of the SDV subject pool, hence the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. IRRELEVANT: the question is not configured for SDV for this subject and it is not expected to be verified. This would be the case of:
- Read-only questions.
- Studies set up for no SDV.
- Studies with Targeted SDV configuration that don't allow SDV overrides.
- Screen failed subjects when excluded from SDV.
|
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | Flags rows that describe a missing question or item value. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Indicates the question type as specified by the study designer. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | A number that represents the unique identifier of the item. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | Indicates the current status of the subject in the study. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Indicates the row position of the item. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DATA_EVENT_TYPE | VARCHAR2(64 CHAR) | Data-event label captured when the transaction provides a non-null event type. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"DATA_EVENT_TYPE",
"SDV_SELECTION_STATUS"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"0",
"0",
"0",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"Central Lab A",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"N",
"N",
"Manual Entry",
"OBLIGATORY",
"OBLIGATORY",
"OBLIGATORY"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"DATA_EVENT_TYPE",
"SDV_SELECTION_STATUS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v11.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v11.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v11.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: LOCKED.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n FORM_EVENT_TYPE | VARCHAR2(64) | Indicates the type of event for changes in form status records. This element currently shows events in the restore flow, setting it to FORM_RESTORED when a record was restored after deletion, otherwise it is NULL. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given form. This field can have the following values: LOCKED: All objects within the form are currently locked.UNLOCKED: The form has no locks applied after being locked at one point in the past.null: No lock has ever been applied to this form.
|
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"N",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"Visit_Complete"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v11.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v11.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v11.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"V11.0",
"description":"Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: LOCKED and FORCED_RAND.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS",
"LOCKED",
"FORCED_RAND"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n UNBLIND_DATE | TIMESTAMP(6) | Indicates the date and time when the first code break was performed and the subject's treatment arm was unblinded. This value is a timestamp. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date. |
\n UNBLIND_REASON | VARCHAR2(255 CHAR) | Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason. |
\n UNBLIND_COMMENT | VARCHAR2(2048 CHAR) | Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given visit. This field can have the following values: null: No lock has ever been applied to this visit. LOCKED: All objects within the visit are currently locked.UNLOCKED: The visit has no locks applied after being locked at one point in the past.
Note: Event or visit locking applies to the entire visit, including the Visit Date. For a visit to be marked as LOCKED, the Visit Date and all associated objects must be locked. If the Visit Date is not locked, the visit cannot be locked. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n FORCED_RAND | CHAR(1) | Indicates whether the subject underwent forced randomization. This helps track how many times forced randomization has been used over the course of the study. This scenario can occur due to a lack of kits for at least one treatment arm in the study at the time of randomization. For this data element, the following values can be displayed: Y: Indicates that a subject underwent forced randomization.N: Indicates that a subject was randomized normally.NULL: Indicates that a subject has not yet been randomized.
|
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER | Numeric identifier that represents the treatment arm. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS",
"LOCKED",
"FORCED_RAND"
],
"data":[
[
"7550C1E7E3CA4B8CAD09ACD1F1E7F580",
"37",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"Tester2",
"United States",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
"10007890",
"2025-10-29T17:00:00.000Z",
"1",
"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"KIT-000457",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"VERIFY_REQUIRED",
"N",
"0",
"Treatment Arm A",
"Arm A dosing schedule",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"DATAHUB_AUT_Site2_Screen13",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N",
"1",
"N",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS",
"LOCKED",
"FORCED_RAND"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v11.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v11.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v12.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"V12.0",
"description":"This API is used to extract blinded clinical data (excluding hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Changes vs v11: Added new Clinical One extension attributes 'ScreenedDate' and 'EnrolledDate' at the subject level when they are not null. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
},
"example":"Snapshot"
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2023-01-01T00:00:00.000Z"
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2099-01-01T00:00:00.000Z"
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":50
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"ErrorResponseExample":{
"description":"ErrorResponseExample",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"INVALID_START_TIME",
"errorMessage":"Invalid fromTimestamp in the request url"
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v12.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v12.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v12.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"V12.0",
"description":"This API is used to extract unblinded clinical data (including hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Changes vs v11: Added new Clinical One extension attributes 'ScreenedDate' and 'EnrolledDate' at the subject level when they are not null. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
},
"example":"Snapshot"
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2023-01-01T00:00:00.000Z"
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string",
"format":"date"
},
"example":"2099-01-01T00:00:00.000Z"
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":50
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"ErrorResponseExample":{
"description":"ErrorResponseExample",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"INVALID_START_TIME",
"errorMessage":"Invalid fromTimestamp in the request url"
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v12.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v12.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v12.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"V12.0",
"description":"Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: LOCKED.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"DATA_EVENT_TYPE",
"SDV_SELECTION_STATUS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | Date/time when the transaction began processing. |
\n TRANSACTION_END | DATE | Date/time when the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n EHR_IMPORTED | CHAR(1) | Indicates if a question was populated via an Electronic Health Record (EHR) data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes. Possible values include Y or N. |
\n SDV_SELECTION_STATUS | VARCHAR2(32 CHAR) | Indicates if, after all applicable Source Data Verification (SDV) settings combined, the question requires verification or not for the subject. This is determined based on the study SDV settings, the SDV strategy assigned to the site, whether the subject is part of the pool of selected subjects for SDV, and SDV settings defined at the item level in form design. For more information, see Understand Source Data Verification. This data element is populated with four possible values: OBLIGATORY: the question requires verification. This means that either the study has a 100% SDV configuration or it has a Targeted SDV configuration and the question is selected for SDV for that given subject.
OPTIONAL: the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. OPTIONAL_CRITICAL: the question is set as a critical variable but the subject is not part of the SDV subject pool, hence the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. IRRELEVANT: the question is not configured for SDV for this subject and it is not expected to be verified. This would be the case of:
- Read-only questions.
- Studies set up for no SDV.
- Studies with Targeted SDV configuration that don't allow SDV overrides.
- Screen failed subjects when excluded from SDV.
|
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given question. This field can have the following values: - <null>: No lock has ever been applied to this question.
LOCKED: The question is currently locked.UNLOCKED: The question has no locks applied after being locked at one point in the past.
Possible values include true or false. |
\n IS_MISSING_ITEM | CHAR(1) | Flags rows that describe a missing question or item value. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit/event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent data element that owns this question. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Designer-provided GUID that identifies the question within the form. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID for the subject event instance that owns this data. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event whose scheduled visit spawned this visit. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property that owns this data element. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DATA_EVENT_TYPE | VARCHAR2(64) | Data-event label captured when the transaction provides a non-null event type. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | The dataset GUID for the subject form item row, corresponding to the ODM co:ItemGUID. |
\n VARIABLE_ID | RAW(16 BYTE) | UUID of the Designer variable or element tied to the question. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Identifier of the normalized measurement unit applied to the value. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section that contains the item. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
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"columns":[
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"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
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"VERIFIED",
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"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
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"HAS_QUERY",
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"columns":[
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"VISIT_WINDOW_BEFORE_HOURS",
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"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"DATA_EVENT_TYPE",
"SDV_SELECTION_STATUS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v12.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v12.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v12.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: LOCKED.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n FORM_EVENT_TYPE | VARCHAR2(64) | Indicates the type of event for changes in form status records. This element currently shows events in the restore flow, setting it to FORM_RESTORED when a record was restored after deletion, otherwise it is NULL. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given form. This field can have the following values: LOCKED: All objects within the form are currently locked.UNLOCKED: The form has no locks applied after being locked at one point in the past.null: No lock has ever been applied to this form.
|
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
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"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE"
],
"data":[
[
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"Study01",
"Study01",
"STUDY01",
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"2025-10-28T09:00:00.000Z",
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"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"Visit_Complete"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
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"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
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"SUBJECT_ID",
"SUBJECT_WID",
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"FORM_ID",
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"FORM_NAME",
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"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
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"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
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"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
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"STUDY_TITLE",
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"STUDY_PHASE",
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"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
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"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
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"VISIT_WINDOW_AFTER_DAYS",
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"VERIFIED",
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"LOCKED",
"SITE_STUDY_VERSION",
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"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
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"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
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],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v12.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v12.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v12.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"V12.0",
"description":"Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: SDV_SELECTION_VISIT_DATE. It also includes all expected dynamic and branch visits in the missing criteria and modifies the logic for IS_MISSING_VISIT.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS",
"LOCKED",
"FORCED_RAND",
"SDV_SELECTION_VISIT_DATE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n UNBLIND_DATE | TIMESTAMP(6) | Indicates the date and time when the first code break was performed and the subject's treatment arm was unblinded. This value is a timestamp. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date. |
\n UNBLIND_REASON | VARCHAR2(255 CHAR) | Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason. |
\n UNBLIND_COMMENT | VARCHAR2(2048 CHAR) | Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n SDV_SELECTION_VISIT_DATE | VARCHAR2(32 CHAR) | This element tracks visit dates for visits that are part of the targeted SDV pool for a subject tied to the record. The possible values include: OBLIGATORY; OPTIONAL; OPTIONAL_CRITICAL; IRRELEVANT |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given visit. This field can have the following values: null: No lock has ever been applied to this visit. LOCKED: All objects within the visit are currently locked.UNLOCKED: The visit has no locks applied after being locked at one point in the past.
Note: Event or visit locking applies to the entire visit, including the Visit Date. For a visit to be marked as LOCKED, the Visit Date and all associated objects must be locked. If the Visit Date is not locked, the visit cannot be locked. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n FORCED_RAND | CHAR(1) | Indicates whether the subject underwent forced randomization. This helps track how many times forced randomization has been used over the course of the study. This scenario can occur due to a lack of kits for at least one treatment arm in the study at the time of randomization. For this data element, the following values can be displayed: Y: Indicates that a subject underwent forced randomization.N: Indicates that a subject was randomized normally.NULL: Indicates that a subject has not yet been randomized.
|
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Audit comment captured when \"Other\" is chosen as the change reason; the system populates \"Rule Execution\" for calculated values. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject; aligns with the numeric SUBJECT_WID described in the Reference folder. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit/event; mirrors the numeric EVENT_WID from the Reference folder. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID pointing to the parent visit from which the current visit was scheduled, matching the parent visit name described by SCHEDULED_FROM_EVENT_NAME. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment arm, paired with TREATMENT_WID to identify the therapy. |
\n TREATMENT_WID | NUMBER | Numeric identifier that represents the treatment arm. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort, aligning with the numeric COHORT_WID definition. |
\n COHORT_WID | NUMBER | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID for the inventory record tied to the dispensed kit. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Identifier of the kit type entered by the study designer when the kit type was created. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Identifier of the IoT-enabled device managed through Oracle Health Sciences mHealth Connector Cloud Services. |
\n RND_STATUS_ID | NUMBER | Numeric identifier that represents the randomization status associated with the subject. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
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"count":1,
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"columns":[
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"EVENT_TYPE",
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"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
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"COHORT_ID",
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"KIT_TYPE_SRC_ID",
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"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
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"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS",
"LOCKED",
"FORCED_RAND",
"SDV_SELECTION_VISIT_DATE"
],
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}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
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"totalResults":1,
"count":0,
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"columns":[
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"STUDY_ID",
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"STUDY_VERSION",
"SITE_ID",
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"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS",
"LOCKED",
"FORCED_RAND",
"SDV_SELECTION_VISIT_DATE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v12.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v12.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v13.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"V13.0",
"description":"Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes all expected items under expected dynamic visits and branch visits scheduled in the missing criteria. It also includes modified logic for IS_MISSING_FORM.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"DATA_EVENT_TYPE",
"SDV_SELECTION_STATUS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | Date/time when the transaction began processing. |
\n TRANSACTION_END | DATE | Date/time when the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n EHR_IMPORTED | CHAR(1) | Indicates if a question was populated via an Electronic Health Record (EHR) data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes. Possible values include Y or N. |
\n SDV_SELECTION_STATUS | VARCHAR2(32 CHAR) | Indicates if, after all applicable Source Data Verification (SDV) settings combined, the question requires verification or not for the subject. This is determined based on the study SDV settings, the SDV strategy assigned to the site, whether the subject is part of the pool of selected subjects for SDV, and SDV settings defined at the item level in form design. For more information, see Understand Source Data Verification. This data element is populated with four possible values: OBLIGATORY: the question requires verification. This means that either the study has a 100% SDV configuration or it has a Targeted SDV configuration and the question is selected for SDV for that given subject.
OPTIONAL: the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. OPTIONAL_CRITICAL: the question is set as a critical variable but the subject is not part of the SDV subject pool, hence the question may be verified but it is not required for that given subject.
This is only applicable for Targeted SDV studies that allow SDV overrides. IRRELEVANT: the question is not configured for SDV for this subject and it is not expected to be verified. This would be the case of:
- Read-only questions.
- Studies set up for no SDV.
- Studies with Targeted SDV configuration that don't allow SDV overrides.
- Screen failed subjects when excluded from SDV.
|
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given question. This field can have the following values: - <null>: No lock has ever been applied to this question.
LOCKED: The question is currently locked.UNLOCKED: The question has no locks applied after being locked at one point in the past.
Possible values include true or false. |
\n IS_MISSING_ITEM | CHAR(1) | Flags rows that describe a missing question or item value. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit/event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent data element that owns this question. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Designer-provided GUID that identifies the question within the form. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID for the subject event instance that owns this data. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event whose scheduled visit spawned this visit. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property that owns this data element. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DATA_EVENT_TYPE | VARCHAR2(64) | Data-event label captured when the transaction provides a non-null event type. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | The dataset GUID for the subject form item row, corresponding to the ODM co:ItemGUID. |
\n VARIABLE_ID | RAW(16 BYTE) | UUID of the Designer variable or element tied to the question. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Identifier of the normalized measurement unit applied to the value. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section that contains the item. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
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"examples":{
"SubjectFormItemsDataSetReport":{
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"columns":[
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"SUBJECT_STATE",
"EVENT_TITLE",
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"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
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"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
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"EHR_IMPORTED",
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"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"Central Lab A",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"N",
"N",
"Manual Entry",
"OBLIGATORY",
"OBLIGATORY",
"OBLIGATORY"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"EHR_ENABLED",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM",
"EHR_IMPORTED",
"DATA_EVENT_TYPE",
"SDV_SELECTION_STATUS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v13.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v13.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v13.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"V13.0",
"description":"Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: LAST_UPDATED_DATE, LAST_UPDATED_BY_ID, LAST_UPDATED_BY_WID, LAST_UPDATED_BY, OBJECT_VERSION_NUMBER, and SOFTWARE_VERSION_NUMBER. It also populates the temporal columns data for scheduled forms, including VERSION_START, VERSION_END, USER_ID, USER_WID, USER_NAME, OPERATION_TYPE, REASON, and COMMENTS.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"SOFTWARE_VERSION_NUMBER",
"OBJECT_VERSION_NUMBER",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE",
"LAST_UPDATED_DATE",
"LAST_UPDATED_BY_ID",
"LAST_UPDATED_BY_WID",
"LAST_UPDATED_BY",
"REASON",
"COMMENTS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n FORM_EVENT_TYPE | VARCHAR2(64) | Indicates the type of event for changes in form status records. This element currently shows events in the restore flow, setting it to FORM_RESTORED when a record was restored after deletion, otherwise it is NULL. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n LAST_UPDATED_BY | VARCHAR2(255 CHAR) | Indicates the information of the user who made the last change on the clinical data. This is only populated for the record of the latest change and it is associated with the data stored in the LAST_UPDATED_DATE data element. Note: The data contained in this element can only be used for current records from the dataset, marked as IS_CURRENT=Y, as the data updates independently of form status versioning. |
\n LAST_UPDATED_DATE | TIMESTAMP(6) | Indicates the time of the most recent clinical data change within a particular form. This includes entering data, clearing data, or restoring data. If no clinical data has been entered in a form, this data element displays a value of NULL. Note: The data contained in this element can only be used for current records from the dataset, marked as IS_CURRENT=Y, as the data updates independently of form status versioning. Moreover, the data contained within this element does not change as a result of Sign, Freeze, Verify, and Lock (SVFL) actions, nor does it change as a result of form associations or site transfers. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given form. This field can have the following values: LOCKED: All objects within the form are currently locked.UNLOCKED: The form has no locks applied after being locked at one point in the past.null: No lock has ever been applied to this form.
|
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENTS | VARCHAR2(2048 CHAR) | Comment recorded for the dataset row change, when provided. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n LAST_UPDATED_BY_ID | RAW(16 BYTE) | GUID of the user who last updated the form row. |
\n LAST_UPDATED_BY_WID | NUMBER | Indicates a user numeric identifier for the user who last updated the form row. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"SOFTWARE_VERSION_NUMBER",
"OBJECT_VERSION_NUMBER",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE",
"LAST_UPDATED_DATE",
"LAST_UPDATED_BY_ID",
"LAST_UPDATED_BY_WID",
"LAST_UPDATED_BY",
"REASON",
"COMMENTS"
],
"data":[
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"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-28T13:34:34.345Z",
"2025-10-29T15:11:33.049Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574435",
"45",
"user1",
"2",
"3",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"N",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"Visit_Complete",
"2025-10-29T15:11:33.049Z",
"33D0D74837F6454B836AAB5BA2574435",
"45",
"user1",
"Other",
"ScreeningForm_VISIT_NEW_FORM_STATUS_EVENT_LEVEL"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"SOFTWARE_VERSION_NUMBER",
"OBJECT_VERSION_NUMBER",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE",
"LAST_UPDATED_DATE",
"LAST_UPDATED_BY_ID",
"LAST_UPDATED_BY_WID",
"LAST_UPDATED_BY",
"REASON",
"COMMENTS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v13.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v13.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v14.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"V14.0",
"description":"Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes all expected forms under expected dynamic and branch visits that are scheduled in the missing criteria.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"SOFTWARE_VERSION_NUMBER",
"OBJECT_VERSION_NUMBER",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE",
"LAST_UPDATED_DATE",
"LAST_UPDATED_BY_ID",
"LAST_UPDATED_BY_WID",
"LAST_UPDATED_BY",
"REASON",
"COMMENTS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n FORM_EVENT_TYPE | VARCHAR2(64) | Indicates the type of event for changes in form status records. This element currently shows events in the restore flow, setting it to FORM_RESTORED when a record was restored after deletion, otherwise it is NULL. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(128) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n LAST_UPDATED_BY | VARCHAR2(255 CHAR) | Indicates the information of the user who made the last change on the clinical data. This is only populated for the record of the latest change and it is associated with the data stored in the LAST_UPDATED_DATE data element. Note: The data contained in this element can only be used for current records from the dataset, marked as IS_CURRENT=Y, as the data updates independently of form status versioning. |
\n LAST_UPDATED_DATE | TIMESTAMP(6) | Indicates the time of the most recent clinical data change within a particular form. This includes entering data, clearing data, or restoring data. If no clinical data has been entered in a form, this data element displays a value of NULL. Note: The data contained in this element can only be used for current records from the dataset, marked as IS_CURRENT=Y, as the data updates independently of form status versioning. Moreover, the data contained within this element does not change as a result of Sign, Freeze, Verify, and Lock (SVFL) actions, nor does it change as a result of form associations or site transfers. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n LOCKED | VARCHAR2(16 CHAR) | Indicates the lock status of the given form. This field can have the following values: LOCKED: All objects within the form are currently locked.UNLOCKED: The form has no locks applied after being locked at one point in the past.null: No lock has ever been applied to this form.
|
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(64) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENTS | VARCHAR2(2048 CHAR) | Comment recorded for the dataset row change, when provided. |
\n IS_CURRENT | VARCHAR2(4) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n LAST_UPDATED_BY_ID | RAW(16 BYTE) | GUID of the user who last updated the form row. |
\n LAST_UPDATED_BY_WID | NUMBER | Indicates a user numeric identifier for the user who last updated the form row. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"SOFTWARE_VERSION_NUMBER",
"OBJECT_VERSION_NUMBER",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE",
"LAST_UPDATED_DATE",
"LAST_UPDATED_BY_ID",
"LAST_UPDATED_BY_WID",
"LAST_UPDATED_BY",
"REASON",
"COMMENTS"
],
"data":[
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"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-28T13:34:34.345Z",
"2025-10-29T15:11:33.049Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574435",
"45",
"user1",
"2",
"3",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"N",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"Visit_Complete",
"2025-10-29T15:11:33.049Z",
"33D0D74837F6454B836AAB5BA2574435",
"45",
"user1",
"Other",
"ScreeningForm_VISIT_NEW_FORM_STATUS_EVENT_LEVEL"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"SOFTWARE_VERSION_NUMBER",
"OBJECT_VERSION_NUMBER",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"LOCKED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"FORM_EVENT_TYPE",
"LAST_UPDATED_DATE",
"LAST_UPDATED_BY_ID",
"LAST_UPDATED_BY_WID",
"LAST_UPDATED_BY",
"REASON",
"COMMENTS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v14.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v14.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/blindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded kits for study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Kits dataset for a single study and mode.
The dataset exposes blinded kit inventory and dispensation history, including study, site, subject, randomization, shipment, lot, kit status, verification/confirmation metadata, and audit columns, without exposing unblinded treatment-arm details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for blinded kits associated with the study and mode.
This version additionally includes the following data points: SCREENING_NUMBER, COUNT_OF_KITS, and IS_NON_SERIALIZED_KIT. It also renames COUNTRY_NAME to COUNTRY.
Required permission: BlindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedKitsDataSetQuery_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedKitsDataSetQuery":{
"description":"BlindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kit context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version associated with the dataset row. |
\n STUDY_MODE | VARCHAR2(64 CHAR) | Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active. Possible values include test, active, or training. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | Indicates the principal investigator's prefix. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | Indicates the Drug Enforcement Administration number associated with the site. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the Drug Enforcement Administration number. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Indicates the site's source data verification strategy. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Indicates the number of initial subjects to be eligible for source data verification, as specified by a study manager. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Indicates if all questions or only critical questions are eligible for source data verification for the initial subjects, as specified by a study manager. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Indicates the percentage of remaining subjects to be eligible for source data verification, as specified by a study manager. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Indicates if all questions or only critical questions are eligible for source data verification for the remaining subjects, as specified by a study manager. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The ZIP or postal code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. This value reflects the country's ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The site's phone number, as entered by the site administrator when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The site's fax number, as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | The site's email address, as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | A site's country, as entered by the site administrator when they created or last modified the site. This value reflects the country's ISO code. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level code attributes associated with the site geography for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.INPROGRESS: the visit was never completed and has one or more required items with no saved data.NEW: the visit was either dynamically triggered or added as part of Advanced Study Versioning (ASV) and has no data.NOT_STARTED: the visit has not been started.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Indicates the system reference name of the parent visit from which the associated visit was scheduled. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization design settings and subject randomization outcome fields associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RAND_NUMBER | VARCHAR2(40) | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study. Can have one of the following values: PENDINGIN TRANSITRECEIVEDCANCELLEDLOSTCONFIRMEDINVALIDPENDING DESTRUCTIONRECEIVED FOR DESTRUCTIONDESTROYEDQUARANTINED
|
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a manual shipment or an automatic shipment. |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n SHIPMENT_RECEIPT_DATE | TIMESTAMP(6) | Indicates the date on which the shipment was received. |
\n SHIPMENT_RECEIVED_BY | VARCHAR2(255 CHAR) | Indicates the user who received the given shipment. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nRequired kit inventory, dispensing, dosing, and verification fields associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_TYPE | VARCHAR2(1020) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include BLISTERPACK, BOTTLE, DEVICE, SYRINGE, OINTMENT, VIAL, INHALER, INFUSION, BOX, or OTHER. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minimum number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA). |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n COUNT_OF_KITS | NUMBER | Indicates the number of kits represented by the inventory record. |
\n IS_NON_SERIALIZED_KIT | CHAR(1) | Indicates whether the inventory record corresponds to a non-serialized kit. Possible values include Y or N. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include ActivityWatch, BloodPressureMonitor, GlucoseMonitor, WeightScale, ECGReader, Spirometer, MobileApp, SmartPillBottle, PulseOximeter, WearablePatch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n CRA_VERIFIED | NUMBER | Indicates whether the inventory record was verified by a Clinical Research Associate (CRA). Possible values include 0 or 1. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the user who confirmed the dispensation of the specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if 'Other' is selected. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | Indicates the unique identifier of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SHIPMENT_RECEIVED_BY_ID | RAW(16 BYTE) | Indicates the user identifier of the user who confirmed receipt of the shipment order. |
\n SHIPMENT_RECEIVED_BY_WID | NUMBER | Indicates the numeric identifier of a user who confirmed receipt of the shipment order. |
\n INVENTORY_ID | RAW(16 BYTE) | Indicates the unique identifier of the study's inventory. |
\n INVENTORY_WID | NUMBER(10) | Indicates the numeric identifier of the study's inventory. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SHIPMENT_WID | NUMBER | A number that represents the unique identifier of a shipment. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_WID | NUMBER | Indicates the numeric identifier of the user who verified inventory data. |
\n CONFIRMED_BY_WID | NUMBER | Indicates the numeric identifier of a user who confirmed the dispensation of a kit during a visit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedKitsDataSetReport":{
"description":"BlindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"Study01",
"test",
"Study01",
"STUDY01",
"Vaccines",
"1.0.0.2",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active27",
"New",
"0",
"10004567",
"Randomized",
"2025-10-29T12:30:00.000Z",
"Blinded Lot 1",
"BLT1",
"2026-12-31T00:00:00.000Z",
"0",
"0",
"SHIP-0001",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"31",
"2025-10-28T12:00:00.000Z",
"testuser1",
"TRK123456",
"Y",
"Y",
"ScreeningForm",
"SCREENINGFORM",
"INPROGRESS",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"0",
"Device",
"ActivityWatch",
"DevicetoCloud",
"BLINDED",
"1",
"1",
"0",
"0",
"Available",
"50281",
"2025-10-29T12:00:00.000Z",
"0",
"AW-50281",
"0",
"N/A",
"Once Daily",
"0",
"0",
"N",
"1",
"1",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"testuser1",
"2025-10-29T12:20:00.000Z",
"2025-10-29T12:58:54.137Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"3",
"Data Entry Error",
"Corrected metadata",
"testuser1",
"Y",
"25",
"455",
"7",
"1001",
"31",
"88",
"88",
"2",
"2025-10-29T13:09:36.857Z",
"424CA68C1E623E82E063BDD14C646211",
"271",
"DATAHUB_AUT_Site2_Screen27",
"DATAHUB_AUT_Site2_Screen27",
"1",
"N",
"2F14BA8314EC4733A7B1504CDF494E16",
"27",
"Clinical Supply Manager - Unblinded (template)"
]
]
}
},
"BlindedKitsDataSetEmptyReport":{
"description":"BlindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-blindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-blindedkits-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, and BRANCH_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767 CHAR) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n VALIDATION_RULES | VARCHAR2(32767 CHAR) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | NUMBER(10) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"DataCollectionDataSetReport":{
"description":"DataCollectionDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"107",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"2",
"0",
"2",
"0",
"21",
"0",
"864",
"5",
"301",
"Treatment Arm A",
"ARM_A",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"N",
"0",
"Y",
"N",
"Arm A",
"ELIGIBILITY_FORM",
"Eligible for Arm A?",
"Yes",
"Screening",
"73",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"-1",
"N/A",
"-1",
"N/A",
"1.0",
"2025-01-01T00:00:00.000Z",
"0",
"346",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"value>=0 and value<=300",
"Weight must be between 0 and 300 kg",
"OnChange:RecalculateBMI",
"N/A",
"REQUIRED",
"N",
"1",
"",
"",
"0",
"3099-12-31T00:00:00.000Z",
"2025-10-29T13:09:36.312Z",
"testuser1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"{}"
]
]
}
},
"DataCollectionDataSetEmptyReport":{
"description":"DataCollectionDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/kitsAndRandomizations":{
"post":{
"tags":[
"Data Hub/Datasets/Get kits and randomization design data for study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Kits and Randomization Design dataset for a single study.
The dataset exposes versioned randomization and supply design configuration, including study-event linkage, randomization definitions, treatment arms, titration and allocation settings, kit types, calculated dose configuration, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for randomization and kit design entities configured for the study versions available in the selected mode.
This version additionally includes the following data points: CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: KitsAndRandomizationDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, STUDYEVENT_ID, RAND_ID, ARM_ID, KIT_ID, and TITRATION in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"KitsAndRandomizationDataSetQuery":{
"description":"KitsAndRandomizationDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"STUDYEVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"RAND_ID",
"sortOrder":"ASC"
},
{
"columnName":"ARM_ID",
"sortOrder":"ASC"
},
{
"columnName":"KIT_ID",
"sortOrder":"ASC"
},
{
"columnName":"TITRATION",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Randomization context | Event context | Kit context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer when they design the randomization in Study Design mode. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization. Possible values include Blinded or Unblinded. |
\n COHORT_NAME | VARCHAR2(32767 CHAR) | Indicates the cohort name, as specified by a study designer. |
\n COHORTTYPE | VARCHAR2(32 CHAR) | Indicates the type of cohort selected by a study designer when creating a randomization design: None, Adaptive, or Demography. Possible values include NoCohort, Adaptive, or Demography. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | The title of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | The ID of the treatment arm, as specified by the study designer when creating the arm. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n RANDOMIZATION_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the randomization data was entered. |
\n RANDOMIZATION_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when randomization data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-window attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | A visit's reference name used in the system. This value is composed by EVENT_TITLE converted to uppercase with blank spaces removed and once created it doesn't update. |
\n EVENT_TYPE | VARCHAR2(32) | The event type of the visit. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates the number of days before the event or activity should happen. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates the number of hours before the event or activity should happen. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates the number of days after the event or activity should happen. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates the number of hours after the event or activity should happen. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit design, supply configuration, and kit-type attributes associated with the study setup.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_TYPE | VARCHAR2(23) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include Blister Pack, Bottle, Device, Syringe, Topical Ointment, Vial, Inhaler, Infusion, Box, or Other. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates how one unit in the kit is measured, specifically its specified value. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculations defined based on subjects' answers to one or more questions. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include Activity Watch, Blood Pressure Monitor, Glucose Monitor, Weight Scale, ECG Reader, Spirometer, Mobile App, Smart Pill Bottle, Pulse Oximeter, Wearable Patch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. Possible values include Blinded, Unblinded, or Unblinded Pharmacist. |
\n KIT_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the kit data was entered. |
\n KIT_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when kit data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose definitions and dosing rules configured for kit supply design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n DOSING_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n PERCISION_FOR_EACH_DOSE | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n ROUND_UP_FOR | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. |
\n USE_LEFTOVER_UNITS_IN_NEXT_DOSE | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata captured with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | The user who last modify the study. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n RAND_ID | RAW(16 BYTE) | GUID of the randomization design. |
\n RAND_WID | NUMBER | A number that represents the unique identifier of the randomization design. |
\n ARM_ID | RAW(16 BYTE) | GUID of the treatment arm. |
\n ARM_WID | NUMBER | A number that represents the unique identifier of the treatment arm. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | VARCHAR2(32767) | Identifier of the cohort selected in the randomization design. |
\n COHORT_WID | VARCHAR2(32767) | A number that represents the unique identifier of the cohort. |
\n STUDYEVENT_ID | RAW(16 BYTE) | GUID of the study event. |
\n STUDYEVENT_WID | NUMBER(10) | A number that represents the unique identifier of the study event. |
\n KIT_ID | RAW(16 BYTE) | GUID of the kit. |
\n KIT_WID | NUMBER(10) | A number that represents the unique identifier of the kit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"KitsAndRandomizationDataSetReport":{
"description":"KitsAndRandomizationDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"testuser1",
"APPROVED",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"26",
"1DAB0F8B8BB249FEBB686596C7598EB1",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"NoCohort",
"1",
"2025-10-29T12:34:57.563Z",
"19",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"1",
"0",
"2025-10-29T12:20:42.956Z",
"3099-12-31T00:00:00.000Z",
"COHORT_1",
"101",
"Default Cohort",
"Y",
"Y",
"Week2",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"ScheduleAbleVisit",
"ONSITE",
"28",
"0",
"2",
"0",
"2",
"0",
"Week3",
"WEEK3",
"Week3",
"1536",
"116",
"5A05BF29727D48D5BBB108991017CF98",
"Connected Syringe Pump",
"BLE",
"0",
"BLINDED",
"SyringeKit",
"SYRINGE",
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"1",
"5.00",
"mL",
"0",
"2025-10-29T12:14:23.304Z",
"3099-12-31T00:00:00.000Z",
"Investigational Product",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"10.00",
"70.00",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)"
]
]
}
},
"KitsAndRandomizationDataSetEmptyReport":{
"description":"KitsAndRandomizationDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
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"EVENT_ID_NAME",
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"KIT_VERSION_END",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
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"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-kitsAndRandomizations-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-kitsandrandomizations-post"
}
},
"/ec-datahub-svc/rest/v2.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Mode of the study, accepts: test, active, or training. This will retrieve all study versions currently in that mode container, plus the study versions that were archived from that mode container.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v2.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v2.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in CDISC ODM-XML format. This extract only includes item level transactions. Clinical One version start timestamp is used to sort the values in the XML file. Clinical One version start timestamp is the time when the user entered the value/transaction occurred in Clinical One.",
"operationId":"getClinicalDataUnblinded_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Mode of the study, accepts: test, active, or training. This will retrieve all study versions currently in that mode container, plus the study versions that were archived from that mode container.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v2.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v2.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract meta data in CDISC ODM-XML format.",
"operationId":"getMetadata_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Mode of the study, accepts: test, active, or training. This will retrieve all study versions currently in that mode container, plus the study versions that were archived from that mode container.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v2.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/queries":{
"post":{
"tags":[
"Data Hub/Datasets/Get queries raised for study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Queries dataset for a single study and mode.
The dataset exposes query lifecycle history raised against clinical data, including query state and comments, rule context, study, site, subject, visit, form, and item context, together with audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns query-history rows for the selected study and mode, not only currently open queries.
This version additionally includes the following data points: REPEAT_FORM_NUMBER.
Required permission: StudyQueryDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and QUERY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"QueryDataSetQuery":{
"description":"QueryDataSetQuery",
"value":{
"selectColumns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"QUERY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Subject context | Event context | Form context | Item context | Query context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. Possible values include 1.3.0.8 or 5.3.0.16. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. Possible values include America/New_York or Asia/Kolkata. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit scheduling, status, and execution attributes associated with the queried record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.NOT_STARTED: the visit has not been started.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. Possible values include 0, 1, or 7. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design, repeat, and status attributes associated with the queried data element.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only receive this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nItem-level values, validation output, derived representations, and item metadata associated with the query.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. Possible values include TEXT, DATETIME, NUMERIC, CHOICE, LABEL, or FILE_UPLOAD. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, label, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Oracle Clinical One Platform integrations. |
\n FORMITEM_IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. Possible values include 0 or 1. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include 0 or 1. |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nQuery context
\nQuery lifecycle fields that describe the discrepancy, its state, ownership, and query-specific classification.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STATE | VARCHAR2(255 CHAR) | Indicates a query's status: OpenedAnsweredClosedCandidate query
|
\n QUERYAGE | NUMBER | Indicates the number of days passed since a query was first opened. - Current (Active) Record: Indicates how many days have passed since the query was first opened until today while it remains open. This means query age should be
0 when the query gets an opened status and increment the longer it remains open. - For candidate and deleted queries, query age should be always
0. - For candidate queries created on one date and opened on a different date, query age should be
0 at the time it gets an opened status and increment the longer it remains open. - For answered queries, reopened queries, and reopened queries with subsequent answers, as long as the status is still opened, query age should indicate how many days have passed since it was first opened until the current system's date.
- Closed Record: Indicates how long the query was open, from the first opened date to the date it was closed.
- Audit (Version-Ended) Record: Indicates the duration that each version of a query was active, measured from when it was opened to when that particular version ended.
|
\n QUERY_COMMENT | VARCHAR2(2048 CHAR) | Indicates a comment associated with a query, as entered by the user who last modified the query. |
\n ASSIGNED_ROLES | VARCHAR2(32767 CHAR) | Indicates the roles that are assigned to receive a query. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit trail metadata that explains when the row version became effective, who changed it, and whether it is current.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(20 CHAR) | Comment for record change. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(32 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(32 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(32 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(32 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(32 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n QUERY_ID | RAW(32 BYTE) | GUID of the query. |
\n QUERY_WID | NUMBER(10) | A number that represents the unique identifier of the query. |
\n USER_ID | RAW(32 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent record. |
\n PARENT_WID | NUMBER(10) | Indicates the numeric identifier of the parent record. A sentinel value of -1 can appear when no parent record applies. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root record. |
\n ROOT_WID | NUMBER(10) | Indicates the numeric identifier of the root record. A sentinel value of -1 can appear when no root record applies. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Indicates the number of times the form has been repeated. |
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the number of times the event has been repeated for the subject. |
\n TRANSACTION_START | DATE | Indicates the transaction start date associated with the queried subject form item record. |
\n TRANSACTION_END | DATE | Indicates the transaction end date associated with the queried subject form item record. |
\n STATE_ID | NUMBER | A number that represents the unique identifier of the query state. |
\n RULE_ID | RAW(32 BYTE) | GUID of the rule. |
\n DISCREPANCY_ID | NUMBER(38) | Indicates the discrepancy identifier associated with the query. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | GUID of the subject form item record associated with the queried data element. |
\n VARIABLE_ID | RAW(16 BYTE) | GUID of the variable. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Indicates the date and time when the referenced property version became effective. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form item record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of the normalized unit. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally as the underlying query dataset row is versioned. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"QueryDataSetReport":{
"description":"QueryDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
[
"3A06FA4026504D819D33D6061B0AF6AB",
"1",
"0",
"Candidate",
"please provide more details ",
"CE5F2D7A9B4C4D1E8F2A6C3B7D8E9A10",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"4F9D07D644904CEAB2F2DEFA02E8921C",
"2",
"DATAHUB_AUT_Site2_Active02",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"0",
"0",
"CF149710CBE24A6BB9266E52B5F5BA0F",
"618",
"Subject Initials",
"2025-10-30T17:02:09.726Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"2",
"Auto query created",
"Auto-created",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-30T17:04:02.544Z",
"1001",
"N",
"Y",
"Site CRA;Data Manager",
"0",
"6529F9EBEB914CED8DAED37B7C3DBCFA",
"41",
"FORM_02",
"6",
"2025-10-30T17:00:00.000Z",
"2025-10-30T17:02:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"ABC",
null,
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"2025-10-30T17:02:09.000Z",
"10",
"30",
"2025",
"17",
"02",
"09",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"ScreeningForm",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"ScreeningForm",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"ABC",
"ABC",
"TEXT",
"TEXT",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"FBDBB9C9A70C470E8E90B812460F00F8",
"2025-12-11T21:45:21.430Z",
"Enter subject initials",
"1",
"0",
"Subject_Initials",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"New",
"DATAHUB_AUT_Site2_Screen02",
"COMPLETED",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"ScreeningForm",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"N",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"candidate"
]
]
}
},
"QueryDataSetEmptyReport":{
"description":"QueryDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-queries-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-queries-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/codelists":{
"post":{
"tags":[
"Data Hub/Datasets/Get codelists for study"
],
"summary":"V2.0",
"description":"Retrieves the study-permissioned Study Level Codelists dataset for a single study and mode.
The dataset exposes versioned codelist configuration used in study design, including study, visit, form, and item context together with codelist definitions, localized code values, display metadata, grouping metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for codelists defined at study, event, form, and item level for the study versions available in the selected mode.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_REFNAME.
Required permission: StudyCodelistDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, CODE_LEVEL, STUDY_VERSION, EVENT_ID, FORM_ID, ITEM_ID, CODE_ID, CODE_VALUE_ID, and LOCALE in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"StudyLevelCodelistsDataSetQuery":{
"description":"StudyLevelCodelistsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_WID",
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_ID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"FORM_WID",
"FORM_ID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_ROLLOVER",
"FORM_IS_REPEATING",
"ITEM_WID",
"ITEM_ID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"CODE_VALUE_ID",
"CODE_VALUE_WID",
"SEQUENCE",
"CODE_VALUE",
"CODE_LABEL",
"CODE",
"LOCALE",
"CODE_ID",
"CODE_WID",
"CODE_NAME",
"CODE_DESCRIPTION",
"CODE_LEVEL",
"CODE_GROUP_ID",
"CODE_GROUP_WID",
"CODE_GROUP_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"USER_ID",
"USER_WID",
"USER_NAME",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_CODELIST_LEVEL",
"DH_TIMESTAMP",
"DISPLAY_CODE_NAME",
"TAG",
"CL_HIDDEN",
"LOINC",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"CODE_LEVEL",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"CODE_ID",
"sortOrder":"ASC"
},
{
"columnName":"CODE_VALUE_ID",
"sortOrder":"ASC"
},
{
"columnName":"LOCALE",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Codelist context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | In this dataset view, STUDY_TITLE is populated with the study description associated with the dataset row. |
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | In this dataset view, STUDY_ID_NAME is populated with the study version title associated with the dataset row. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nCodelist context
\nCodelist values, localization fields, and codelist-level metadata associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CODE_NAME | VARCHAR2(255 CHAR) | The name of the codelist. |
\n DISPLAY_CODE_NAME | VARCHAR2(255 CHAR) | Name that appears in a dropdown when a codelist is used. |
\n CODE_LABEL | VARCHAR2(1000 CHAR) | Full code name that gets displayed. |
\n CODE_VALUE | VARCHAR2(1000 CHAR) | The code value. |
\n CODE | VARCHAR2(255 CHAR) | Custom defined identifier for a code in Clinical One Cloud Service. |
\n CODE_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the code record. |
\n CODE_GROUP_NAME | VARCHAR2(255 CHAR) | Name that identifies the code group. |
\n CODE_LEVEL | VARCHAR2(32 CHAR) | Describes whether the record is at a system or custom level codelist. If it includes a custom codelist, this value indicates whether it is a static or dynamic codelist. Possible values include SYSTEM, CUSTOM, or DYNAMIC. |
\n DH_CODELIST_LEVEL | VARCHAR2(5) | Indicates the Data Hub codelist row level represented in the dataset. Possible values include item or study. |
\n LOCALE | VARCHAR2(255 CHAR) | Code locale. English, Chinese and Japanese languages are supported. Possible values include en-US, zh-CN, or ja-JP. |
\n LOINC | VARCHAR2(255 CHAR) | Indicates the LOINC code associated with the codelist value. |
\n TAG | VARCHAR2(1000 CHAR) | User defined tag for the code. |
\n CL_HIDDEN | NUMBER(1) | Denotes if a code is hidden to end users. Possible values include 0 or 1. |
\n SEQUENCE | NUMBER | Corresponds to the order assigned to a code in a codelist. This determines the order in which the codes in a codelist get listed. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the user-entered EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. This value does not change if the associated EVENT_TITLE is updated in a subsequent study version. |
\n EVENT_TYPE | VARCHAR2(32) | Indicates the event type configured for the visit, for example ONSITE. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Numeric visit order that follows the visit schedule as it was created. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE of the Scheduled From visit as defined in the Visit Schedule. If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit, in addition to the DELAY_DAYS field. |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
Possible values include 1 SECTION FORM, 2 SECTION FORM, or LAB FORM. |
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question configured for the item, as specified by the study designer. Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n ITEM_GROUP_ID | NUMBER | If this is a group question, indicates the group question ID. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | A question's reference code, as specified by the study designer when they created the question. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment for record change. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n CODE_VALUE_ID | RAW(16 BYTE) | GUID of the codelist value. |
\n CODE_VALUE_WID | NUMBER(10) | A number that represents the unique identifier of the codelist value. |
\n CODE_ID | RAW(16 BYTE) | GUID of the codelist. |
\n CODE_WID | NUMBER(10) | A number that represents the unique identifier of the codelist. |
\n CODE_GROUP_ID | RAW(16 BYTE) | GUID of the codelist group. |
\n CODE_GROUP_WID | NUMBER(10) | A number that represents the unique identifier of the codelist group. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"StudyLevelCodelistsDataSetReport":{
"description":"StudyLevelCodelistsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_WID",
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_ID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"FORM_WID",
"FORM_ID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_ROLLOVER",
"FORM_IS_REPEATING",
"ITEM_WID",
"ITEM_ID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"CODE_VALUE_ID",
"CODE_VALUE_WID",
"SEQUENCE",
"CODE_VALUE",
"CODE_LABEL",
"CODE",
"LOCALE",
"CODE_ID",
"CODE_WID",
"CODE_NAME",
"CODE_DESCRIPTION",
"CODE_LEVEL",
"CODE_GROUP_ID",
"CODE_GROUP_WID",
"CODE_GROUP_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"USER_ID",
"USER_WID",
"USER_NAME",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_CODELIST_LEVEL",
"DH_TIMESTAMP",
"DISPLAY_CODE_NAME",
"TAG",
"CL_HIDDEN",
"LOINC",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"25",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"205",
"57CCABE13C174836A48BCEDD46247AB8",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"WEEK1",
"2",
"0",
"2",
"0",
"21",
"0",
"864",
"5",
"73",
"3ADB1375C6714B8C97CA14AFA175D739",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"346",
"8F70423FE2204ED5A3B0B00F363C3306",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"D9C7A5634B804F28E053B7834C649CE1",
"2085",
"50",
"LT-43",
"Utena County",
"LT-43",
"ja-JP",
"E663E145A108493188C99CB71BA63CD6",
"13",
"Lithuania",
"Code list for Lithuania States",
"SYSTEM",
"4B9B6E1A2F3C4D5E8A9B0C1D2E3F4A5B",
"-1",
"Clinical One Default Code List",
"2025-10-29T11:41:11.052Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"1",
"00000000000000000000000000000001",
"43",
"testuser1",
"Initial load",
"Seeded by migration script",
"Y",
"study",
"2025-10-29T12:34:56.972Z",
"Lithuania Counties",
"geography",
"0",
"",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)"
]
]
}
},
"StudyLevelCodelistsDataSetEmptyReport":{
"description":"StudyLevelCodelistsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_WID",
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_ID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"FORM_WID",
"FORM_ID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_ROLLOVER",
"FORM_IS_REPEATING",
"ITEM_WID",
"ITEM_ID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"CODE_VALUE_ID",
"CODE_VALUE_WID",
"SEQUENCE",
"CODE_VALUE",
"CODE_LABEL",
"CODE",
"LOCALE",
"CODE_ID",
"CODE_WID",
"CODE_NAME",
"CODE_DESCRIPTION",
"CODE_LEVEL",
"CODE_GROUP_ID",
"CODE_GROUP_WID",
"CODE_GROUP_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"USER_ID",
"USER_WID",
"USER_NAME",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_CODELIST_LEVEL",
"DH_TIMESTAMP",
"DISPLAY_CODE_NAME",
"TAG",
"CL_HIDDEN",
"LOINC",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-codelists-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-codelists-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes subject event, form, study, site, contact, shipping, SDV, and site capability data points, including REPEAT_SEQUENCE_NUMBER, VERSION_START, VERSION_END, DH_TIMESTAMP, SUBJECT_EVENT_INST_ID, SUBJECT_STATE, EVENT_TITLE, EVENT_REFNAME, EVENT_ID_NAME, VISIT_IS_REQUIRED, VISIT_ORDER, SUBJECT_EVENTINST_FORM_WID, FORM_STATUS, SITE_ID_NAME, SITE_STATUS, PHONE, FAX, EMAIL, shipping address fields, study metadata, and SDV/site capability fields. It also removes legacy fields including DH_SUBJECT_FORMITEMS_VERSION_START, DH_SUBJECT_FORMITEMS_VERSION_END, REQUIRED, SF_REPEAT_SEQUENCE_NUMBER, SUBVIS_FORMS_DATASET_ID, STUDY_NAME, FROM_SITE_ID, FROM_SITE_WID, FROM_SITE_NAME, TO_SITE_ID, TO_SITE_WID, TO_SITE_NAME, SUBJECT_VIS_DATASET_VERSION_START, SUBJECT_VIS_DATASET_VERSION_END, SUBJECT_NAME, SUBJECT_TRANSFER_WID, SUBJECT_TRANSFER_ID, SUBJECT_TRANSFER_VERSION_START, SUBJECT_TRANSFER_VERSION_END, OLD_SUBJECT_NUMBER, NEW_SUBJECT_NUMBER, EVENT_NAME, and SUBVIS_FORMS_DATASET_IS_CURRENT.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | Date/time when the transaction began processing. |
\n TRANSACTION_END | DATE | Date/time when the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent data element that owns this question. |
\n PARENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER(10) | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Designer-provided GUID that identifies the question within the form. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance associated with this row, pairing with the numeric SUBJECT_EVENT_INST_WID identifier. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event whose schedule spawned this visit. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Decoded or display-friendly representation of the stored response. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | The dataset GUID for the subject form item row, corresponding to the ODM co:ItemGUID. |
\n VARIABLE_ID | RAW(16 BYTE) | UUID of the Designer variable or element tied to the question. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Identifier of the normalized measurement unit applied to the item value. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section that owns this item. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"LAB01",
"Targeted",
"50",
"Reduced",
"Tester2",
"N"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes form, subject event, study, site, contact, shipping, SDV, and site capability data points, including FORM_STATUS, DH_TIMESTAMP, study metadata, site metadata, contact and shipping fields, SUBJECT_EVENT_INST_ID, SUBJECT_STATE, EVENT_TITLE, EVENT_REFNAME, EVENT_ID_NAME, VISIT_IS_REQUIRED, VISIT_ORDER, SITE_STUDY_VERSION, DRUG_DESTRUCTION_CAPABLE, ADD_SUBJECTS, SCREEN_SUBJECTS, RANDOMIZE_SUBJECTS, DISPENSE_TO_SUBJECTS, DEA_NUMBER, EXPIRATION, TIMEZONE, SHIPPING_ATTENTION, PI_PREFIX, SDV_GROUP_NAME, INITIAL_SUBJECTS_COUNT, INITIAL_SUBJECTS_SDV_TYPE, and REMAINING_SUBJECTS_SDV_TYPE. It also removes legacy fields including SUBJECT_FORMS_VERSION_START, SUBJECT_FORMS_VERSION_END, SUBJECT_FORMS_USER_ID, SUBJECT_FORMS_USER_WID, SUBJECT_FORMS_USER_NAME, DH_SUBJECT_FORMS_IS_CURRENT, SUBJECT_FORMS_DH_TIMESTAMP, ID, STUDY_NAME, FROM_SITE_ID, FROM_SITE_WID, FROM_SITE_NAME, TO_SITE_ID, TO_SITE_WID, TO_SITE_NAME, OBJECT_VERSION_NUMBER, SOFTWARE_VERSION_NUMBER, REASON, COMMENT, SUBJECT_NAME, SUBJECT_TRANSFER_WID, SUBJECT_TRANSFER_ID, SUBJECT_TRANSFER_VERSION_START, SUBJECT_TRANSFER_VERSION_END, OLD_SUBJECT_NUMBER, NEW_SUBJECT_NUMBER, EVENT_NAME, and IS_REQUIRED.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and FORM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Dr.",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes study, site, subject, visit, kit, contact, shipping, SDV, and site capability data points, including COUNTRY_NAME, VISIT_ORDER, DH_TIMESTAMP, KIT_DESCRIPTION, QUANTITY, SUBJECT_STATE, SITE_ID_NAME, SITE_STATUS, STUDY_ID_NAME, STUDY_TITLE, STUDY_REFNAME, STUDY_PHASE, BLINDING_TYPE, THERAPEUTIC_AREA, EVENT_TITLE, EVENT_REFNAME, EVENT_ID_NAME, DRUG_DESTRUCTION_CAPABLE, PI_PREFIX, ADD_SUBJECTS, SCREEN_SUBJECTS, RANDOMIZE_SUBJECTS, SITE_STUDY_VERSION, DISPENSE_TO_SUBJECTS, DEA_NUMBER, EXPIRATION, TIMEZONE, SHIPPING_ATTENTION, SDV_GROUP_NAME, INITIAL_SUBJECTS_COUNT, INITIAL_SUBJECTS_SDV_TYPE, REMAINING_SUBJECTS_PERCENTAGE, REMAINING_SUBJECTS_SDV_TYPE, PHONE, FAX, EMAIL, and shipping address fields. It also removes legacy fields including SUBJECT_NAME, EVENT_NAME, STUDY_NAME, SUBJECT_TRANSFER_WID, SUBJECT_TRANSFER_ID, SUBJECT_TRANSFER_VERSION_START, SUBJECT_TRANSFER_VERSION_END, OLD_SUBJECT_NUMBER, NEW_SUBJECT_NUMBER, FROM_SITE_ID, FROM_SITE_WID, FROM_SITE_NAME, TO_SITE_ID, TO_SITE_WID, and TO_SITE_NAME.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | CHAR(1) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | NUMBER | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER(10) | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER(10) | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier that represents the treatment arm. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED"
],
"data":[
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"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"false",
"Dr.",
"true",
"true",
"true",
"1.0.0.3",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes study, site, subject, visit, contact, shipping, SDV, and site capability data points, including COUNTRY_NAME, VISIT_ORDER, DH_TIMESTAMP, SUBJECT_STATE, SITE_ID_NAME, SITE_STATUS, STUDY_ID_NAME, STUDY_TITLE, STUDY_REFNAME, THERAPEUTIC_AREA, STUDY_PHASE, BLINDING_TYPE, EVENT_TITLE, EVENT_REFNAME, EVENT_ID_NAME, RAND_NUMBER, KIT_NUMBERS, SITE_STUDY_VERSION, DRUG_DESTRUCTION_CAPABLE, PI_PREFIX, ADD_SUBJECTS, SCREEN_SUBJECTS, RANDOMIZE_SUBJECTS, DISPENSE_TO_SUBJECTS, DEA_NUMBER, EXPIRATION, TIMEZONE, SHIPPING_ATTENTION, SDV_GROUP_NAME, INITIAL_SUBJECTS_COUNT, INITIAL_SUBJECTS_SDV_TYPE, REMAINING_SUBJECTS_PERCENTAGE, REMAINING_SUBJECTS_SDV_TYPE, PHONE, FAX, EMAIL, and shipping address fields. It also removes legacy fields including STUDY_NAME, FROM_SITE_ID, FROM_SITE_WID, FROM_SITE_NAME, TO_SITE_ID, TO_SITE_WID, TO_SITE_NAME, SUBJECT_NAME, SUBJECT_TRANSFER_WID, SUBJECT_TRANSFER_ID, SUBJECT_TRANSFER_VERSION_START, SUBJECT_TRANSFER_VERSION_END, OLD_SUBJECT_NUMBER, NEW_SUBJECT_NUMBER, and EVENT_NAME.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedSubjectDataSetQuery_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | CHAR(1) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER(10) | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER(10) | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: TOTAL_VISITS, TOTAL_FORMS, COMPLETED_VISITS, TOTAL_FORMS_COMPLETED_VISITS, and COMPLETED_FORMS.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveSubjectDataSetQuery_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"DESCRIPTION",
"SUBJECT_NUMBER",
"OLD_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"STUDY_NAME",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY",
"INVESTIGATOR",
"IS_CURRENT",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS"
],
"whereColumns":[
{
"columnName":"VERSION_START",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"VERSION_START",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_NAME | VARCHAR2(64 CHAR) | Study identifier associated with the subject row. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the subject's site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"DESCRIPTION",
"SUBJECT_NUMBER",
"OLD_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"STUDY_NAME",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY",
"INVESTIGATOR",
"IS_CURRENT",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"Initial subject creation",
"Created via data hub load",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site1_Active05",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"T24.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"N",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"India",
"Tester2",
"N",
"11",
"27",
"1",
"1",
"6"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"DESCRIPTION",
"SUBJECT_NUMBER",
"OLD_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"STUDY_NAME",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY",
"INVESTIGATOR",
"IS_CURRENT",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v2.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: BLOCK_NUMBER.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"KIT_NUMBER",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | NUMBER | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(255 CHAR) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER(10) | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER(10) | Numeric identifier of the confirming user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER(10) | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"KIT_NUMBER",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
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"Boston",
"US",
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"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"Site",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"DATAHUB_AUT_Site2_Active13",
"Complete",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"19",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"0",
"0",
"1",
"Assigned",
"2025-10-29T17:31:09.030Z",
"MLOT1",
"BLT1",
"MLOT1",
"BLT1",
"2030-12-31T00:00:00.000Z",
"2026-12-31T00:00:00.000Z",
"10",
"0",
"10",
"0",
"9A8B7C6D5E4F4A1B8C7D6E5F4A3B2C1D",
"1001",
"SHIP-0002",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"TRK123999",
"1",
"Y",
"Week2",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"DISPENSATION",
"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
"28",
"0",
"2",
"0",
"2",
"0",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"Week3",
"WEEK3",
"Week3",
"1536",
"Device",
"ActivityWatch",
"DevicetoCloud",
"0",
"UNBLINDED",
"D26E345F8CBD44B6A22C666F11D1F04D",
"27",
"Device",
"DEVICE",
"1",
"1",
"0",
"N/A",
"0",
"0",
"0",
"424CA68C1E523E82E063BDD14C646211",
"255",
"50262",
"50254",
"mHC2CDevice",
"Dispensed",
"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
"N/A",
"Once Daily",
"0",
"0",
"false",
"1",
"1",
"7E6D5C4B3A29100FEE12DDCCBBAA9988",
"0",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"0",
"70",
"2025-10-29T17:31:19.861Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"4",
"Data correction",
"Updated during data sync",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"Y",
"11223344556677889900AABBCCDDEEFF",
"88",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"A1B2C3D4E5F60718293A4B5C6D7E8F90",
"88",
"Site Pharmacist",
"2025-10-29T12:20:00.000Z",
"2",
"2025-10-29T17:32:35.284Z",
"BLK-0001"
]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"KIT_NUMBER",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v2.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v2.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/blindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded kits for study"
],
"summary":"V3.0",
"description":"Retrieves the study-permissioned Blinded Kits dataset for a single study and mode.
The dataset exposes blinded kit inventory and dispensation history, including study, site, subject, randomization, shipment, lot, kit status, verification/confirmation metadata, and audit columns, without exposing unblinded treatment-arm details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for blinded kits associated with the study and mode.
This version additionally includes the following data points: ORDER_TYPE.
Required permission: BlindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedKitsDataSetQuery_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedKitsDataSetQuery":{
"description":"BlindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kit context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version associated with the dataset row. |
\n STUDY_MODE | VARCHAR2(64 CHAR) | Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active. Possible values include test, active, or training. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | Indicates the principal investigator's prefix. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | Indicates the Drug Enforcement Administration number associated with the site. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the Drug Enforcement Administration number. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Indicates the site's source data verification strategy. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Indicates the number of initial subjects to be eligible for source data verification, as specified by a study manager. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Indicates if all questions or only critical questions are eligible for source data verification for the initial subjects, as specified by a study manager. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Indicates the percentage of remaining subjects to be eligible for source data verification, as specified by a study manager. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Indicates if all questions or only critical questions are eligible for source data verification for the remaining subjects, as specified by a study manager. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The ZIP or postal code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. This value reflects the country's ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The site's phone number, as entered by the site administrator when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The site's fax number, as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | The site's email address, as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | A site's country, as entered by the site administrator when they created or last modified the site. This value reflects the country's ISO code. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level code attributes associated with the site geography for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.INPROGRESS: the visit was never completed and has one or more required items with no saved data.NEW: the visit was either dynamically triggered or added as part of Advanced Study Versioning (ASV) and has no data.NOT_STARTED: the visit has not been started.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Indicates the system reference name of the parent visit from which the associated visit was scheduled. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization design settings and subject randomization outcome fields associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RAND_NUMBER | VARCHAR2(40) | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n ORDER_TYPE | VARCHAR2(50 CHAR) | Indicates how the shipment was initiated. Possible values include INITIAL, MANUAL, or RESUPPLY. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study. Can have one of the following values: PENDINGIN TRANSITRECEIVEDCANCELLEDLOSTCONFIRMEDINVALIDPENDING DESTRUCTIONRECEIVED FOR DESTRUCTIONDESTROYEDQUARANTINED
|
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a manual shipment or an automatic shipment. |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n SHIPMENT_RECEIPT_DATE | TIMESTAMP(6) | Indicates the date on which the shipment was received. |
\n SHIPMENT_RECEIVED_BY | VARCHAR2(255 CHAR) | Indicates the user who received the given shipment. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nRequired kit inventory, dispensing, dosing, and verification fields associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_TYPE | VARCHAR2(1020) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include BLISTERPACK, BOTTLE, DEVICE, SYRINGE, OINTMENT, VIAL, INHALER, INFUSION, BOX, or OTHER. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minimum number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA). |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n COUNT_OF_KITS | NUMBER | Indicates the number of kits represented by the inventory record. |
\n IS_NON_SERIALIZED_KIT | CHAR(1) | Indicates whether the inventory record corresponds to a non-serialized kit. Possible values include Y or N. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include ActivityWatch, BloodPressureMonitor, GlucoseMonitor, WeightScale, ECGReader, Spirometer, MobileApp, SmartPillBottle, PulseOximeter, WearablePatch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n CRA_VERIFIED | NUMBER | Indicates whether the inventory record was verified by a Clinical Research Associate (CRA). Possible values include 0 or 1. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the user who confirmed the dispensation of the specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if 'Other' is selected. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | Indicates the unique identifier of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SHIPMENT_RECEIVED_BY_ID | RAW(16 BYTE) | Indicates the user identifier of the user who confirmed receipt of the shipment order. |
\n SHIPMENT_RECEIVED_BY_WID | NUMBER | Indicates the numeric identifier of a user who confirmed receipt of the shipment order. |
\n INVENTORY_ID | RAW(16 BYTE) | Indicates the unique identifier of the study's inventory. |
\n INVENTORY_WID | NUMBER(10) | Indicates the numeric identifier of the study's inventory. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SHIPMENT_WID | NUMBER | A number that represents the unique identifier of a shipment. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_WID | NUMBER | Indicates the numeric identifier of the user who verified inventory data. |
\n CONFIRMED_BY_WID | NUMBER | Indicates the numeric identifier of a user who confirmed the dispensation of a kit during a visit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedKitsDataSetReport":{
"description":"BlindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"Study01",
"test",
"Study01",
"STUDY01",
"Vaccines",
"1.0.0.2",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active27",
"New",
"0",
"10004567",
"Randomized",
"2025-10-29T12:30:00.000Z",
"Blinded Lot 1",
"BLT1",
"2026-12-31T00:00:00.000Z",
"0",
"0",
"SHIP-0001",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"31",
"2025-10-28T12:00:00.000Z",
"testuser1",
"TRK123456",
"Y",
"Y",
"ScreeningForm",
"SCREENINGFORM",
"INPROGRESS",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"0",
"Device",
"ActivityWatch",
"DevicetoCloud",
"BLINDED",
"1",
"1",
"0",
"0",
"Available",
"50281",
"2025-10-29T12:00:00.000Z",
"0",
"AW-50281",
"0",
"N/A",
"Once Daily",
"0",
"0",
"N",
"1",
"1",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"testuser1",
"2025-10-29T12:20:00.000Z",
"2025-10-29T12:58:54.137Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"3",
"Data Entry Error",
"Corrected metadata",
"testuser1",
"Y",
"25",
"455",
"7",
"1001",
"31",
"88",
"88",
"2",
"2025-10-29T13:09:36.857Z",
"424CA68C1E623E82E063BDD14C646211",
"271",
"DATAHUB_AUT_Site2_Screen27",
"DATAHUB_AUT_Site2_Screen27",
"1",
"N",
"Outbound",
"2F14BA8314EC4733A7B1504CDF494E16",
"27",
"Clinical Supply Manager - Unblinded (template)"
]
]
}
},
"BlindedKitsDataSetEmptyReport":{
"description":"BlindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-blindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-blindedkits-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: EVENT_ID, SCHEDULED_FROM_EVENT_REFNAME, SCHEDULED_FROM_EVENT_ID, SCHEDULED_FROM_EVENT_WID, FORM_ID, and ITEM_ID.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767 CHAR) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n VALIDATION_RULES | VARCHAR2(32767 CHAR) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | RAW(16 BYTE) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"DataCollectionDataSetReport":{
"description":"DataCollectionDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"WEEK1",
"3279AFB1AA3C44CFB6D6C419AAAC8A84",
"202",
"2",
"0",
"2",
"0",
"21",
"0",
"864",
"5",
"301",
"Treatment Arm A",
"ARM_A",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"N",
"0",
"Y",
"N",
"Arm A",
"ELIGIBILITY_FORM",
"Eligible for Arm A?",
"Yes",
"Screening",
"3ADB1375C6714B8C97CA14AFA175D739",
"73",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"-1",
"N/A",
"-1",
"N/A",
"1.0",
"2025-01-01T00:00:00.000Z",
"0",
"8F70423FE2204ED5A3B0B00F363C3306",
"346",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"value>=0 and value<=300",
"Weight must be between 0 and 300 kg",
"OnChange:RecalculateBMI",
"N/A",
"REQUIRED",
"N",
"1",
"",
"",
"0",
"3099-12-31T00:00:00.000Z",
"2025-10-29T13:09:36.312Z",
"testuser1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"{}"
]
]
}
},
"DataCollectionDataSetEmptyReport":{
"description":"DataCollectionDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/kitsAndRandomizations":{
"post":{
"tags":[
"Data Hub/Datasets/Get kits and randomization design data for study"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Kits and Randomization Design dataset for a single study.
The dataset exposes versioned randomization and supply design configuration, including study-event linkage, randomization definitions, treatment arms, titration and allocation settings, kit types, calculated dose configuration, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for randomization and kit design entities configured for the study versions available in the selected mode.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_ID, SCHEDULED_FROM_EVENT_WID, and SCHEDULED_FROM_EVENT_REFNAME.
Required permission: KitsAndRandomizationDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, STUDYEVENT_ID, RAND_ID, ARM_ID, KIT_ID, SCHEDULED_FROM_EVENT_ID, and TITRATION in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"KitsAndRandomizationDataSetQuery":{
"description":"KitsAndRandomizationDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"STUDYEVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"RAND_ID",
"sortOrder":"ASC"
},
{
"columnName":"ARM_ID",
"sortOrder":"ASC"
},
{
"columnName":"KIT_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"TITRATION",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Randomization context | Event context | Kit context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer when they design the randomization in Study Design mode. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization. Possible values include Blinded or Unblinded. |
\n COHORT_NAME | VARCHAR2(32767 CHAR) | Indicates the cohort name, as specified by a study designer. |
\n COHORTTYPE | VARCHAR2(32 CHAR) | Indicates the type of cohort selected by a study designer when creating a randomization design: None, Adaptive, or Demography. Possible values include NoCohort, Adaptive, or Demography. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | The title of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | The ID of the treatment arm, as specified by the study designer when creating the arm. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n RANDOMIZATION_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the randomization data was entered. |
\n RANDOMIZATION_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when randomization data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-window attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | A visit's reference name used in the system. This value is composed by EVENT_TITLE converted to uppercase with blank spaces removed and once created it doesn't update. |
\n EVENT_TYPE | VARCHAR2(32) | The event type of the visit. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates the number of days before the event or activity should happen. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates the number of hours before the event or activity should happen. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates the number of days after the event or activity should happen. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates the number of hours after the event or activity should happen. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit design, supply configuration, and kit-type attributes associated with the study setup.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_TYPE | VARCHAR2(23) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include Blister Pack, Bottle, Device, Syringe, Topical Ointment, Vial, Inhaler, Infusion, Box, or Other. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates how one unit in the kit is measured, specifically its specified value. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculations defined based on subjects' answers to one or more questions. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include Activity Watch, Blood Pressure Monitor, Glucose Monitor, Weight Scale, ECG Reader, Spirometer, Mobile App, Smart Pill Bottle, Pulse Oximeter, Wearable Patch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. Possible values include Blinded, Unblinded, or Unblinded Pharmacist. |
\n KIT_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the kit data was entered. |
\n KIT_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when kit data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose definitions and dosing rules configured for kit supply design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n DOSING_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n PERCISION_FOR_EACH_DOSE | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n ROUND_UP_FOR | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. |
\n USE_LEFTOVER_UNITS_IN_NEXT_DOSE | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata captured with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | The user who last modify the study. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n RAND_ID | RAW(16 BYTE) | GUID of the randomization design. |
\n RAND_WID | NUMBER | A number that represents the unique identifier of the randomization design. |
\n ARM_ID | RAW(16 BYTE) | GUID of the treatment arm. |
\n ARM_WID | NUMBER | A number that represents the unique identifier of the treatment arm. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | VARCHAR2(32767) | Identifier of the cohort selected in the randomization design. |
\n COHORT_WID | VARCHAR2(32767) | A number that represents the unique identifier of the cohort. |
\n STUDYEVENT_ID | RAW(16 BYTE) | GUID of the study event. |
\n STUDYEVENT_WID | NUMBER(10) | A number that represents the unique identifier of the study event. |
\n KIT_ID | RAW(16 BYTE) | GUID of the kit. |
\n KIT_WID | NUMBER(10) | A number that represents the unique identifier of the kit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"KitsAndRandomizationDataSetReport":{
"description":"KitsAndRandomizationDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
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"PERCISION_FOR_EACH_DOSE",
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"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
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"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"testuser1",
"APPROVED",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"26",
"1DAB0F8B8BB249FEBB686596C7598EB1",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"NoCohort",
"1",
"2025-10-29T12:34:57.563Z",
"19",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"1",
"0",
"2025-10-29T12:20:42.956Z",
"3099-12-31T00:00:00.000Z",
"COHORT_1",
"101",
"Default Cohort",
"Y",
"Y",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"ScheduleAbleVisit",
"ONSITE",
"28",
"0",
"2",
"0",
"2",
"0",
"Week3",
"WEEK3",
"Week3",
"1536",
"116",
"5A05BF29727D48D5BBB108991017CF98",
"Connected Syringe Pump",
"BLE",
"0",
"BLINDED",
"SyringeKit",
"SYRINGE",
"1",
"1",
"5.00",
"mL",
"0",
"2025-10-29T12:14:23.304Z",
"3099-12-31T00:00:00.000Z",
"Investigational Product",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"10.00",
"70.00",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)"
]
]
}
},
"KitsAndRandomizationDataSetEmptyReport":{
"description":"KitsAndRandomizationDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-kitsAndRandomizations-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-kitsandrandomizations-post"
}
},
"/ec-datahub-svc/rest/v3.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v3.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v3.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v3.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v3.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract meta data in CDISC ODM-XML format.",
"operationId":"getMetadata_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v3.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/queries":{
"post":{
"tags":[
"Data Hub/Datasets/Get queries raised for study"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Queries dataset for a single study and mode.
The dataset exposes query lifecycle history raised against clinical data, including query state and comments, rule context, study, site, subject, visit, form, and item context, together with audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns query-history rows for the selected study and mode, not only currently open queries.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER.
Required permission: StudyQueryDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and QUERY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_12",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"QueryDataSetQuery":{
"description":"QueryDataSetQuery",
"value":{
"selectColumns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"QUERY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Subject context | Event context | Form context | Item context | Query context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. Possible values include 1.3.0.8 or 5.3.0.16. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. Possible values include America/New_York or Asia/Kolkata. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit scheduling, status, and execution attributes associated with the queried record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.NOT_STARTED: the visit has not been started.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. Possible values include 0, 1, or 7. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design, repeat, and status attributes associated with the queried data element.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only receive this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nItem-level values, validation output, derived representations, and item metadata associated with the query.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. Possible values include TEXT, DATETIME, NUMERIC, CHOICE, LABEL, or FILE_UPLOAD. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, label, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Oracle Clinical One Platform integrations. |
\n FORMITEM_IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. Possible values include 0 or 1. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include 0 or 1. |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nQuery context
\nQuery lifecycle fields that describe the discrepancy, its state, ownership, and query-specific classification.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STATE | VARCHAR2(255 CHAR) | Indicates a query's status: OpenedAnsweredClosedCandidate query
|
\n QUERYAGE | NUMBER | Indicates the number of days passed since a query was first opened. - Current (Active) Record: Indicates how many days have passed since the query was first opened until today while it remains open. This means query age should be
0 when the query gets an opened status and increment the longer it remains open. - For candidate and deleted queries, query age should be always
0. - For candidate queries created on one date and opened on a different date, query age should be
0 at the time it gets an opened status and increment the longer it remains open. - For answered queries, reopened queries, and reopened queries with subsequent answers, as long as the status is still opened, query age should indicate how many days have passed since it was first opened until the current system's date.
- Closed Record: Indicates how long the query was open, from the first opened date to the date it was closed.
- Audit (Version-Ended) Record: Indicates the duration that each version of a query was active, measured from when it was opened to when that particular version ended.
|
\n QUERY_COMMENT | VARCHAR2(2048 CHAR) | Indicates a comment associated with a query, as entered by the user who last modified the query. |
\n ASSIGNED_ROLES | VARCHAR2(32767 CHAR) | Indicates the roles that are assigned to receive a query. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit trail metadata that explains when the row version became effective, who changed it, and whether it is current.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(20 CHAR) | Comment for record change. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(32 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(32 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(32 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(32 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(32 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n QUERY_ID | RAW(32 BYTE) | GUID of the query. |
\n QUERY_WID | NUMBER(10) | A number that represents the unique identifier of the query. |
\n USER_ID | RAW(32 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent record. |
\n PARENT_WID | NUMBER(10) | Indicates the numeric identifier of the parent record. A sentinel value of -1 can appear when no parent record applies. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root record. |
\n ROOT_WID | NUMBER(10) | Indicates the numeric identifier of the root record. A sentinel value of -1 can appear when no root record applies. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Indicates the number of times the form has been repeated. |
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the number of times the event has been repeated for the subject. |
\n TRANSACTION_START | DATE | Indicates the transaction start date associated with the queried subject form item record. |
\n TRANSACTION_END | DATE | Indicates the transaction end date associated with the queried subject form item record. |
\n STATE_ID | NUMBER | A number that represents the unique identifier of the query state. |
\n RULE_ID | RAW(32 BYTE) | GUID of the rule. |
\n DISCREPANCY_ID | NUMBER(38) | Indicates the discrepancy identifier associated with the query. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | GUID of the subject form item record associated with the queried data element. |
\n VARIABLE_ID | RAW(16 BYTE) | GUID of the variable. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Indicates the date and time when the referenced property version became effective. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form item record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of the normalized unit. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally as the underlying query dataset row is versioned. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"QueryDataSetReport":{
"description":"QueryDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
[
"3A06FA4026504D819D33D6061B0AF6AB",
"1",
"0",
"Candidate",
"please provide more details ",
"CE5F2D7A9B4C4D1E8F2A6C3B7D8E9A10",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"4F9D07D644904CEAB2F2DEFA02E8921C",
"2",
"DATAHUB_AUT_Site2_Active02",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"0",
"0",
"CF149710CBE24A6BB9266E52B5F5BA0F",
"618",
"Subject Initials",
"2025-10-30T17:02:09.726Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"2",
"Auto query created",
"Auto-created",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-30T17:04:02.544Z",
"1001",
"N",
"Y",
"Site CRA;Data Manager",
"0",
"6529F9EBEB914CED8DAED37B7C3DBCFA",
"41",
"FORM_02",
"6",
"2025-10-30T17:00:00.000Z",
"2025-10-30T17:02:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"ABC",
null,
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"2025-10-30T17:02:09.000Z",
"10",
"30",
"2025",
"17",
"02",
"09",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"ScreeningForm",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"ScreeningForm",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"ABC",
"ABC",
"TEXT",
"TEXT",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"FBDBB9C9A70C470E8E90B812460F00F8",
"2025-12-11T21:45:21.430Z",
"Enter subject initials",
"1",
"0",
"Subject_Initials",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"New",
"DATAHUB_AUT_Site2_Screen02",
"DATAHUB_AUT_Site2_Active02",
"COMPLETED",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"ScreeningForm",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"N",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"candidate"
]
]
}
},
"QueryDataSetEmptyReport":{
"description":"QueryDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-queries-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-queries-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/codelists":{
"post":{
"tags":[
"Data Hub/Datasets/Get codelists for study"
],
"summary":"V3.0",
"description":"Retrieves the study-permissioned Study Level Codelists dataset for a single study and mode.
The dataset exposes versioned codelist configuration used in study design, including study, visit, form, and item context together with codelist definitions, localized code values, display metadata, grouping metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for codelists defined at study, event, form, and item level for the study versions available in the selected mode.
This version additionally includes the following data points: SITE_ASSOCIATION and CODELIST_MODE.
Required permission: StudyCodelistDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, CODE_LEVEL, STUDY_VERSION, EVENT_ID, FORM_ID, ITEM_ID, CODE_ID, CODE_VALUE_ID, LOCALE, and CODELIST_MODE in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_13",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"StudyLevelCodelistsDataSetQuery":{
"description":"StudyLevelCodelistsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_WID",
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_ID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"FORM_WID",
"FORM_ID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_ROLLOVER",
"FORM_IS_REPEATING",
"ITEM_WID",
"ITEM_ID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"CODE_VALUE_ID",
"CODE_VALUE_WID",
"SEQUENCE",
"CODE_VALUE",
"CODE_LABEL",
"CODE",
"LOCALE",
"CODE_ID",
"CODE_WID",
"CODE_NAME",
"CODE_DESCRIPTION",
"CODE_LEVEL",
"CODE_GROUP_ID",
"CODE_GROUP_WID",
"CODE_GROUP_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"USER_ID",
"USER_WID",
"USER_NAME",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_CODELIST_LEVEL",
"DH_TIMESTAMP",
"DISPLAY_CODE_NAME",
"TAG",
"CL_HIDDEN",
"LOINC",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"SITE_ASSOCIATION",
"CODELIST_MODE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"CODE_LEVEL",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"CODE_ID",
"sortOrder":"ASC"
},
{
"columnName":"CODE_VALUE_ID",
"sortOrder":"ASC"
},
{
"columnName":"LOCALE",
"sortOrder":"ASC"
},
{
"columnName":"CODELIST_MODE",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Codelist context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | In this dataset view, STUDY_TITLE is populated with the study description associated with the dataset row. |
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | In this dataset view, STUDY_ID_NAME is populated with the study version title associated with the dataset row. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nCodelist context
\nCodelist values, localization fields, and codelist-level metadata associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CODE_NAME | VARCHAR2(255 CHAR) | The name of the codelist. |
\n DISPLAY_CODE_NAME | VARCHAR2(255 CHAR) | Name that appears in a dropdown when a codelist is used. |
\n CODE_LABEL | VARCHAR2(1000 CHAR) | Full code name that gets displayed. |
\n CODE_VALUE | VARCHAR2(1000 CHAR) | The code value. |
\n CODE | VARCHAR2(255 CHAR) | Custom defined identifier for a code in Clinical One Cloud Service. |
\n CODE_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the code record. |
\n CODE_GROUP_NAME | VARCHAR2(255 CHAR) | Name that identifies the code group. |
\n CODE_LEVEL | VARCHAR2(32 CHAR) | Describes whether the record is at a system or custom level codelist. If it includes a custom codelist, this value indicates whether it is a static or dynamic codelist. Possible values include SYSTEM, CUSTOM, or DYNAMIC. |
\n DH_CODELIST_LEVEL | VARCHAR2(5) | Indicates the Data Hub codelist row level represented in the dataset. Possible values include item or study. |
\n SITE_ASSOCIATION | VARCHAR2(32767 CHAR) | Indicates which sites in that mode the code list is mapped to with a value of either ALL SITES or an alphabetical list of the sites based on site ID. This field only populates for CODELIST_LEVEL = study. |
\n CODELIST_MODE | VARCHAR2(16 CHAR) | Indicates the mode in which the associated site was created: Training, Testing, or Active. Possible values include test, active, or training. |
\n LOCALE | VARCHAR2(255 CHAR) | Code locale. English, Chinese and Japanese languages are supported. Possible values include en-US, zh-CN, or ja-JP. |
\n LOINC | VARCHAR2(255 CHAR) | Indicates the LOINC code associated with the codelist value. |
\n TAG | VARCHAR2(1000 CHAR) | User defined tag for the code. |
\n CL_HIDDEN | NUMBER(1) | Denotes if a code is hidden to end users. Possible values include 0 or 1. |
\n SEQUENCE | NUMBER | Corresponds to the order assigned to a code in a codelist. This determines the order in which the codes in a codelist get listed. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the user-entered EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. This value does not change if the associated EVENT_TITLE is updated in a subsequent study version. |
\n EVENT_TYPE | VARCHAR2(32) | Indicates the event type configured for the visit, for example ONSITE. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Numeric visit order that follows the visit schedule as it was created. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE of the Scheduled From visit as defined in the Visit Schedule. If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit, in addition to the DELAY_DAYS field. |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
Possible values include 1 SECTION FORM, 2 SECTION FORM, or LAB FORM. |
\n FORM_IS_REPEATING | VARCHAR2(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question configured for the item, as specified by the study designer. Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n ITEM_GROUP_ID | NUMBER | If this is a group question, indicates the group question ID. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | A question's reference code, as specified by the study designer when they created the question. |
\n FORMITEM_IS_REQUIRED | VARCHAR2(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | VARCHAR2(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n HIDDEN | VARCHAR2(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment for record change. |
\n IS_CURRENT | VARCHAR2(4) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n CODE_VALUE_ID | RAW(16 BYTE) | GUID of the codelist value. |
\n CODE_VALUE_WID | NUMBER(10) | A number that represents the unique identifier of the codelist value. |
\n CODE_ID | RAW(16 BYTE) | GUID of the codelist. |
\n CODE_WID | NUMBER(10) | A number that represents the unique identifier of the codelist. |
\n CODE_GROUP_ID | RAW(16 BYTE) | GUID of the codelist group. |
\n CODE_GROUP_WID | NUMBER(10) | A number that represents the unique identifier of the codelist group. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"StudyLevelCodelistsDataSetReport":{
"description":"StudyLevelCodelistsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_WID",
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_ID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"FORM_WID",
"FORM_ID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_ROLLOVER",
"FORM_IS_REPEATING",
"ITEM_WID",
"ITEM_ID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"CODE_VALUE_ID",
"CODE_VALUE_WID",
"SEQUENCE",
"CODE_VALUE",
"CODE_LABEL",
"CODE",
"LOCALE",
"CODE_ID",
"CODE_WID",
"CODE_NAME",
"CODE_DESCRIPTION",
"CODE_LEVEL",
"CODE_GROUP_ID",
"CODE_GROUP_WID",
"CODE_GROUP_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"USER_ID",
"USER_WID",
"USER_NAME",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_CODELIST_LEVEL",
"DH_TIMESTAMP",
"DISPLAY_CODE_NAME",
"TAG",
"CL_HIDDEN",
"LOINC",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"SITE_ASSOCIATION",
"CODELIST_MODE"
],
"data":[
[
"25",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"205",
"57CCABE13C174836A48BCEDD46247AB8",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"WEEK1",
"2",
"0",
"2",
"0",
"21",
"0",
"864",
"5",
"73",
"3ADB1375C6714B8C97CA14AFA175D739",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"346",
"8F70423FE2204ED5A3B0B00F363C3306",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"D9C7A5634B804F28E053B7834C649CE1",
"2085",
"50",
"LT-43",
"Utena County",
"LT-43",
"ja-JP",
"E663E145A108493188C99CB71BA63CD6",
"13",
"Lithuania",
"Code list for Lithuania States",
"SYSTEM",
"4B9B6E1A2F3C4D5E8A9B0C1D2E3F4A5B",
"-1",
"Clinical One Default Code List",
"2025-10-29T11:41:11.052Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"1",
"00000000000000000000000000000001",
"43",
"testuser1",
"Initial load",
"Seeded by migration script",
"Y",
"study",
"2025-10-29T12:34:56.972Z",
"Lithuania Counties",
"geography",
"0",
"",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"Site1,Site2",
"test"
]
]
}
},
"StudyLevelCodelistsDataSetEmptyReport":{
"description":"StudyLevelCodelistsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_WID",
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_WID",
"EVENT_ID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"FORM_WID",
"FORM_ID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_ROLLOVER",
"FORM_IS_REPEATING",
"ITEM_WID",
"ITEM_ID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"CODE_VALUE_ID",
"CODE_VALUE_WID",
"SEQUENCE",
"CODE_VALUE",
"CODE_LABEL",
"CODE",
"LOCALE",
"CODE_ID",
"CODE_WID",
"CODE_NAME",
"CODE_DESCRIPTION",
"CODE_LEVEL",
"CODE_GROUP_ID",
"CODE_GROUP_WID",
"CODE_GROUP_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"USER_ID",
"USER_WID",
"USER_NAME",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_CODELIST_LEVEL",
"DH_TIMESTAMP",
"DISPLAY_CODE_NAME",
"TAG",
"CL_HIDDEN",
"LOINC",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"SITE_ASSOCIATION",
"CODELIST_MODE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-codelists-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-codelists-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: REPEAT_FORM_NUMBER, OUTER_REPEAT, and INNER_REPEAT.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER(10) | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER(10) | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Designer-provided GUID that identifies the question within the form. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID for the subject event instance that owns this data. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent event from which the current scheduled visit originates. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Decoded or display-friendly representation of the stored response. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"0",
"0",
"0",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: REPEAT_FORM_NUMBER, OUTER_REPEAT, INNER_REPEAT, ASSOCIATED_EVENT_ID, ASSOCIATED_EVENT_WID, ASSOCIATED_EVENT_NAME, ASSOCIATED_EVENT_INSTANCE_NUM, ASSOCIATED_FORM_ID, ASSOCIATED_FORM_WID, ASSOCIATED_FORM_NAME, ASSOCIATED_FORM_REFNAME, ASSOCIATED_FORM_TYPE, ASSOCIATED_REPEAT_SEQUENCE_NUM, and ASSOCIATED_STUDY_VERSION.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: IS_MISSING_VISIT.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y for scheduled visits or N for unscheduled ones. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | NUMBER | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier that represents the treatment arm. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
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"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
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"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
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"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"50262",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"false",
"Dr.",
"true",
"true",
"true",
"1.0.0.3",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: IS_MISSING_VISIT.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedSubjectDataSetQuery_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes study metadata, site metadata, contact, shipping, SDV, and site capability data points, including COUNTRY_NAME, DH_TIMESTAMP, STUDY_ID_NAME, STUDY_TITLE, STUDY_REFNAME, STUDY_PHASE, THERAPEUTIC_AREA, BLINDING_TYPE, SITE_ID_NAME, SITE_STATUS, ADDRESS_STREET_1, ADDRESS_STREET_2, ADDRESS_CITY, ADDRESS_STATE_OR_PROV_OR_CNTY, ADDRESS_POSTALCODE, ADDRESS_COUNTRY, FAX, EMAIL, PHONE, SHIPPING_ADDRESS_1, SHIPPING_ADDRESS_2, SHIPPING_CITY, SHIPPING_STATE_OR_PROV_OR_CNTY, SHIPPING_ZIP, SHIPPING_COUNTRY, SHIPPING_FAX, SHIPPING_EMAIL, SHIPPING_PHONE, SDV_GROUP_NAME, INITIAL_SUBJECTS_COUNT, INITIAL_SUBJECTS_SDV_TYPE, REMAINING_SUBJECTS_PERCENTAGE, REMAINING_SUBJECTS_SDV_TYPE, SITE_STUDY_VERSION, DRUG_DESTRUCTION_CAPABLE, ADD_SUBJECTS, SCREEN_SUBJECTS, RANDOMIZE_SUBJECTS, DISPENSE_TO_SUBJECTS, DEA_NUMBER, EXPIRATION, TIMEZONE, SHIPPING_ATTENTION, and PI_PREFIX. It also removes STUDY_NAME and renames COUNTRY to COUNTRY_NAME.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveSubjectDataSetQuery_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"N",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"Initial subject creation",
"Created via data hub load",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"1.0.0.3",
"false",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Dr."
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v3.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: BLOCK_NUMBER.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"KIT_NUMBER",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(255 CHAR) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER(10) | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER(10) | Numeric identifier of the confirming user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER(10) | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"KIT_NUMBER",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"Site",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"DATAHUB_AUT_Site2_Active13",
"Complete",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"19",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"0",
"0",
"1",
"Assigned",
"2025-10-29T17:31:09.030Z",
"MLOT1",
"BLT1",
"MLOT1",
"BLT1",
"2030-12-31T00:00:00.000Z",
"2026-12-31T00:00:00.000Z",
"10",
"0",
"10",
"0",
"9A8B7C6D5E4F4A1B8C7D6E5F4A3B2C1D",
"1001",
"SHIP-0002",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"TRK123999",
"1",
"Y",
"Week2",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"DISPENSATION",
"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
"28",
"0",
"2",
"0",
"2",
"0",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"Week3",
"WEEK3",
"Week3",
"1536",
"Device",
"ActivityWatch",
"DevicetoCloud",
"0",
"UNBLINDED",
"D26E345F8CBD44B6A22C666F11D1F04D",
"27",
"Device",
"DEVICE",
"1",
"1",
"0",
"N/A",
"0",
"0",
"0",
"424CA68C1E523E82E063BDD14C646211",
"255",
"50262",
"50254",
"mHC2CDevice",
"Dispensed",
"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
"N/A",
"Once Daily",
"0",
"0",
"false",
"1",
"1",
"7E6D5C4B3A29100FEE12DDCCBBAA9988",
"0",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"0",
"70",
"2025-10-29T17:31:19.861Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"4",
"Data correction",
"Updated during data sync",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"Y",
"11223344556677889900AABBCCDDEEFF",
"88",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"A1B2C3D4E5F60718293A4B5C6D7E8F90",
"88",
"Site Pharmacist",
"2025-10-29T12:20:00.000Z",
"2",
"2025-10-29T17:32:35.284Z",
"BLK-0001"
]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"KIT_NUMBER",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v3.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/blindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded kits for study"
],
"summary":"V4.0",
"description":"Retrieves the study-permissioned Blinded Kits dataset for a single study and mode.
The dataset exposes blinded kit inventory and dispensation history, including study, site, subject, randomization, shipment, lot, kit status, verification/confirmation metadata, and audit columns, without exposing unblinded treatment-arm details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for blinded kits associated with the study and mode.
This version additionally includes the following data points: SHIPMENT_RCVD_SITE_DEPOT_DATE.
Required permission: BlindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedKitsDataSetQuery_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedKitsDataSetQuery":{
"description":"BlindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RCVD_SITE_DEPOT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kit context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version associated with the dataset row. |
\n STUDY_MODE | VARCHAR2(64 CHAR) | Indicates the study mode used in the referencing data in a custom report, such as Testing, Training, or Active. Possible values include test, active, or training. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | Indicates the principal investigator's prefix. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | Indicates the Drug Enforcement Administration number associated with the site. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the Drug Enforcement Administration number. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Indicates the site's source data verification strategy. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Indicates the number of initial subjects to be eligible for source data verification, as specified by a study manager. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Indicates if all questions or only critical questions are eligible for source data verification for the initial subjects, as specified by a study manager. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Indicates the percentage of remaining subjects to be eligible for source data verification, as specified by a study manager. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Indicates if all questions or only critical questions are eligible for source data verification for the remaining subjects, as specified by a study manager. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The ZIP or postal code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. This value reflects the country's ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The site's phone number, as entered by the site administrator when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The site's fax number, as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | The site's email address, as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | A site's country, as entered by the site administrator when they created or last modified the site. This value reflects the country's ISO code. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level code attributes associated with the site geography for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.INPROGRESS: the visit was never completed and has one or more required items with no saved data.NEW: the visit was either dynamically triggered or added as part of Advanced Study Versioning (ASV) and has no data.NOT_STARTED: the visit has not been started.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Indicates the system reference name of the parent visit from which the associated visit was scheduled. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization design settings and subject randomization outcome fields associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RAND_NUMBER | VARCHAR2(40) | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n ORDER_TYPE | VARCHAR2(50 CHAR) | Indicates how the shipment was initiated. Possible values include INITIAL, MANUAL, or RESUPPLY. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study. Can have one of the following values: PENDINGIN TRANSITRECEIVEDCANCELLEDLOSTCONFIRMEDINVALIDPENDING DESTRUCTIONRECEIVED FOR DESTRUCTIONDESTROYEDQUARANTINED
|
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a manual shipment or an automatic shipment. |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n SHIPMENT_RECEIPT_DATE | TIMESTAMP(6) | Indicates the date on which the shipment was received. |
\n SHIPMENT_RCVD_SITE_DEPOT_DATE | TIMESTAMP(6) | Indicates the user-editable date when the shipment was received at the site or depot. Unlike SHIPMENT_RECEIPT_DATE, which is system-generated, this value reflects the actual receipt date entered by the user. |
\n SHIPMENT_RECEIVED_BY | VARCHAR2(255 CHAR) | Indicates the user who received the given shipment. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nRequired kit inventory, dispensing, dosing, and verification fields associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_TYPE | VARCHAR2(1020) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include BLISTERPACK, BOTTLE, DEVICE, SYRINGE, OINTMENT, VIAL, INHALER, INFUSION, BOX, or OTHER. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minimum number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA). |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n COUNT_OF_KITS | NUMBER | Indicates the number of kits represented by the inventory record. |
\n IS_NON_SERIALIZED_KIT | CHAR(1) | Indicates whether the inventory record corresponds to a non-serialized kit. Possible values include Y or N. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include ActivityWatch, BloodPressureMonitor, GlucoseMonitor, WeightScale, ECGReader, Spirometer, MobileApp, SmartPillBottle, PulseOximeter, WearablePatch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n CRA_VERIFIED | NUMBER | Indicates whether the inventory record was verified by a Clinical Research Associate (CRA). Possible values include 0 or 1. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the user who confirmed the dispensation of the specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if 'Other' is selected. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | Indicates the unique identifier of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SHIPMENT_RECEIVED_BY_ID | RAW(16 BYTE) | Indicates the user identifier of the user who confirmed receipt of the shipment order. |
\n SHIPMENT_RECEIVED_BY_WID | NUMBER | Indicates the numeric identifier of a user who confirmed receipt of the shipment order. |
\n INVENTORY_ID | RAW(16 BYTE) | Indicates the unique identifier of the study's inventory. |
\n INVENTORY_WID | NUMBER(10) | Indicates the numeric identifier of the study's inventory. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SHIPMENT_WID | NUMBER | A number that represents the unique identifier of a shipment. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_WID | NUMBER | Indicates the numeric identifier of the user who verified inventory data. |
\n CONFIRMED_BY_WID | NUMBER | Indicates the numeric identifier of a user who confirmed the dispensation of a kit during a visit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedKitsDataSetReport":{
"description":"BlindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RCVD_SITE_DEPOT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"Study01",
"test",
"Study01",
"STUDY01",
"Vaccines",
"1.0.0.2",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active27",
"New",
"0",
"10004567",
"Randomized",
"2025-10-29T12:30:00.000Z",
"Blinded Lot 1",
"BLT1",
"2026-12-31T00:00:00.000Z",
"0",
"0",
"SHIP-0001",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T11:45:00.000Z",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"31",
"2025-10-28T12:00:00.000Z",
"testuser1",
"TRK123456",
"Y",
"Y",
"ScreeningForm",
"SCREENINGFORM",
"INPROGRESS",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"0",
"Device",
"ActivityWatch",
"DevicetoCloud",
"BLINDED",
"1",
"1",
"0",
"0",
"Available",
"50281",
"2025-10-29T12:00:00.000Z",
"0",
"AW-50281",
"0",
"N/A",
"Once Daily",
"0",
"0",
"N",
"1",
"1",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"testuser1",
"2025-10-29T12:20:00.000Z",
"2025-10-29T12:58:54.137Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"3",
"Data Entry Error",
"Corrected metadata",
"testuser1",
"Y",
"25",
"455",
"7",
"1001",
"31",
"88",
"88",
"2",
"2025-10-29T13:09:36.857Z",
"424CA68C1E623E82E063BDD14C646211",
"271",
"DATAHUB_AUT_Site2_Screen27",
"DATAHUB_AUT_Site2_Screen27",
"1",
"N",
"Outbound",
"2F14BA8314EC4733A7B1504CDF494E16",
"27",
"Clinical Supply Manager - Unblinded (template)"
]
]
}
},
"BlindedKitsDataSetEmptyReport":{
"description":"BlindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_ID_NAME",
"STUDY_MODE",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_VERSION",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_NAME",
"SITE_ID_NAME",
"SUBJECT_NUMBER",
"SUBJECT_STATE",
"RERANDOMIZATION",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"BLINDED_LOT_TITLE",
"BLINDED_LOT_SHORT_NAME",
"BLINDED_LOT_EXPIRATION_DATE",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"SHIPMENT_RCVD_SITE_DEPOT_DATE",
"SHIPMENT_RECEIVED_BY_ID",
"SHIPMENT_RECEIVED_BY_WID",
"SHIPMENT_RECEIPT_DATE",
"SHIPMENT_RECEIVED_BY",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"CRA_VERIFIED",
"BALANCE_UNITS",
"KIT_STATUS",
"KIT_NUMBER",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_NAME",
"IS_CURRENT",
"STUDY_WID",
"SITE_WID",
"SUBJECT_WID",
"SHIPMENT_WID",
"USER_WID",
"VERIFIED_BY_WID",
"CONFIRMED_BY_WID",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"INVENTORY_ID",
"INVENTORY_WID",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-blindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-blindedkits-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: ALLOW_MULTIPLE_INSTANCES and ALLOW_FUTURE_DATE.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_14",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_MULTIPLE_INSTANCES | NUMBER | Indicates whether multiple instances of the same form can be added within a visit. Possible values include 0 or 1. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767 CHAR) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ALLOW_FUTURE_DATE | NUMBER(1) | For Date/Time questions. Indicates if the user is allowed to enter a future date. Possible values include 0 or 1. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n VALIDATION_RULES | VARCHAR2(32767 CHAR) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | RAW(16 BYTE) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"DataCollectionDataSetReport":{
"description":"DataCollectionDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"3279AFB1AA3C44CFB6D6C419AAAC8A84",
"WEEK1",
"202",
"2",
"0",
"2",
"0",
"21",
"0",
"864",
"5",
"301",
"Treatment Arm A",
"ARM_A",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"N",
"0",
"Y",
"N",
"Arm A",
"ELIGIBILITY_FORM",
"Eligible for Arm A?",
"Yes",
"Screening",
"3ADB1375C6714B8C97CA14AFA175D739",
"73",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"-1",
"N/A",
"-1",
"N/A",
"1.0",
"2025-01-01T00:00:00.000Z",
"0",
"0",
"8F70423FE2204ED5A3B0B00F363C3306",
"346",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"value>=0 and value<=300",
"Weight must be between 0 and 300 kg",
"OnChange:RecalculateBMI",
"N/A",
"REQUIRED",
"N",
"1",
"",
"",
"0",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"2025-10-29T13:09:36.312Z",
"testuser1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"{}"
]
]
}
},
"DataCollectionDataSetEmptyReport":{
"description":"DataCollectionDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/kitsAndRandomizations":{
"post":{
"tags":[
"Data Hub/Datasets/Get kits and randomization design data for study"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Kits and Randomization Design dataset for a single study.
The dataset exposes versioned randomization and supply design configuration, including study-event linkage, randomization definitions, treatment arms, titration and allocation settings, kit types, calculated dose configuration, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for randomization and kit design entities configured for the study versions available in the selected mode.
This version additionally includes the following data points: SERIALIZED, HAZARDOUS_MATERIAL, and CONTROL_SUBSTANCE.
Required permission: KitsAndRandomizationDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, STUDYEVENT_ID, RAND_ID, ARM_ID, KIT_ID, SCHEDULED_FROM_EVENT_ID, and TITRATION in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_15",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"KitsAndRandomizationDataSetQuery":{
"description":"KitsAndRandomizationDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"STUDYEVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"RAND_ID",
"sortOrder":"ASC"
},
{
"columnName":"ARM_ID",
"sortOrder":"ASC"
},
{
"columnName":"KIT_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"TITRATION",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Randomization context | Event context | Kit context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer when they design the randomization in Study Design mode. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization. Possible values include Blinded or Unblinded. |
\n COHORT_NAME | VARCHAR2(32767 CHAR) | Indicates the cohort name, as specified by a study designer. |
\n COHORTTYPE | VARCHAR2(32 CHAR) | Indicates the type of cohort selected by a study designer when creating a randomization design: None, Adaptive, or Demography. Possible values include NoCohort, Adaptive, or Demography. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | The title of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | The ID of the treatment arm, as specified by the study designer when creating the arm. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n RANDOMIZATION_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the randomization data was entered. |
\n RANDOMIZATION_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when randomization data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-window attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | A visit's reference name used in the system. This value is composed by EVENT_TITLE converted to uppercase with blank spaces removed and once created it doesn't update. |
\n EVENT_TYPE | VARCHAR2(32) | The event type of the visit. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates the number of days before the event or activity should happen. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates the number of hours before the event or activity should happen. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates the number of days after the event or activity should happen. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates the number of hours after the event or activity should happen. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit design, supply configuration, and kit-type attributes associated with the study setup.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_TYPE | VARCHAR2(23) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include Blister Pack, Bottle, Device, Syringe, Topical Ointment, Vial, Inhaler, Infusion, Box, or Other. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates how one unit in the kit is measured, specifically its specified value. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculations defined based on subjects' answers to one or more questions. |
\n SERIALIZED | CHAR(1) | Indicates whether a kit is serialized or non-serialized. Possible values include Y or N. |
\n CONTROL_SUBSTANCE | CHAR(1) | Indicates whether a kit constitutes a controlled substance. Possible values include Y or N. |
\n HAZARDOUS_MATERIAL | CHAR(1) | Indicates whether a kit contains hazardous materials. Possible values include Y or N. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include Activity Watch, Blood Pressure Monitor, Glucose Monitor, Weight Scale, ECG Reader, Spirometer, Mobile App, Smart Pill Bottle, Pulse Oximeter, Wearable Patch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. Possible values include Blinded, Unblinded, or Unblinded Pharmacist. |
\n KIT_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the kit data was entered. |
\n KIT_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when kit data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose definitions and dosing rules configured for kit supply design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n DOSING_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n PERCISION_FOR_EACH_DOSE | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n ROUND_UP_FOR | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. |
\n USE_LEFTOVER_UNITS_IN_NEXT_DOSE | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata captured with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | The user who last modify the study. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n RAND_ID | RAW(16 BYTE) | GUID of the randomization design. |
\n RAND_WID | NUMBER | A number that represents the unique identifier of the randomization design. |
\n ARM_ID | RAW(16 BYTE) | GUID of the treatment arm. |
\n ARM_WID | NUMBER | A number that represents the unique identifier of the treatment arm. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | VARCHAR2(32767) | Identifier of the cohort selected in the randomization design. |
\n COHORT_WID | VARCHAR2(32767) | A number that represents the unique identifier of the cohort. |
\n STUDYEVENT_ID | RAW(16 BYTE) | GUID of the study event. |
\n STUDYEVENT_WID | NUMBER(10) | A number that represents the unique identifier of the study event. |
\n KIT_ID | RAW(16 BYTE) | GUID of the kit. |
\n KIT_WID | NUMBER(10) | A number that represents the unique identifier of the kit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"KitsAndRandomizationDataSetReport":{
"description":"KitsAndRandomizationDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"testuser1",
"APPROVED",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"26",
"1DAB0F8B8BB249FEBB686596C7598EB1",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"NoCohort",
"1",
"2025-10-29T12:34:57.563Z",
"19",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"1",
"0",
"2025-10-29T12:20:42.956Z",
"3099-12-31T00:00:00.000Z",
"COHORT_1",
"101",
"Default Cohort",
"Y",
"Y",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"ScheduleAbleVisit",
"ONSITE",
"28",
"0",
"2",
"0",
"2",
"0",
"Week3",
"WEEK3",
"Week3",
"1536",
"116",
"5A05BF29727D48D5BBB108991017CF98",
"Connected Syringe Pump",
"BLE",
"0",
"BLINDED",
"SyringeKit",
"SYRINGE",
"1",
"1",
"5.00",
"mL",
"0",
"2025-10-29T12:14:23.304Z",
"3099-12-31T00:00:00.000Z",
"Y",
"N",
"N",
"Investigational Product",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"10.00",
"70.00",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)"
]
]
}
},
"KitsAndRandomizationDataSetEmptyReport":{
"description":"KitsAndRandomizationDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-kitsAndRandomizations-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-kitsandrandomizations-post"
}
},
"/ec-datahub-svc/rest/v4.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v4.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v4.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v4.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v4.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract meta data in CDISC ODM-XML format.",
"operationId":"getMetadata_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v4.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/queries":{
"post":{
"tags":[
"Data Hub/Datasets/Get queries raised for study"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Queries dataset for a single study and mode.
The dataset exposes query lifecycle history raised against clinical data, including query state and comments, rule context, study, site, subject, visit, form, and item context, together with audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns query-history rows for the selected study and mode, not only currently open queries.
This version additionally includes the following data points: IS_AUTO_QUERY and QUERY_TYPE.
Required permission: StudyQueryDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and QUERY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_16",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"QueryDataSetQuery":{
"description":"QueryDataSetQuery",
"value":{
"selectColumns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"QUERY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Subject context | Event context | Form context | Item context | Query context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. Possible values include 1.3.0.8 or 5.3.0.16. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. Possible values include America/New_York or Asia/Kolkata. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit scheduling, status, and execution attributes associated with the queried record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.NOT_STARTED: the visit has not been started.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. Possible values include 0, 1, or 7. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design, repeat, and status attributes associated with the queried data element.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only receive this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nItem-level values, validation output, derived representations, and item metadata associated with the query.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. Possible values include TEXT, DATETIME, NUMERIC, CHOICE, LABEL, or FILE_UPLOAD. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, label, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Oracle Clinical One Platform integrations. |
\n FORMITEM_IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. Possible values include 0 or 1. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include 0 or 1. |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nQuery context
\nQuery lifecycle fields that describe the discrepancy, its state, ownership, and query-specific classification.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n QUERY_TYPE | VARCHAR2(16 CHAR) | Indicates the query type. |
\n STATE | VARCHAR2(255 CHAR) | Indicates a query's status: OpenedAnsweredClosedCandidate query
|
\n QUERYAGE | NUMBER | Indicates the number of days passed since a query was first opened. - Current (Active) Record: Indicates how many days have passed since the query was first opened until today while it remains open. This means query age should be
0 when the query gets an opened status and increment the longer it remains open. - For candidate and deleted queries, query age should be always
0. - For candidate queries created on one date and opened on a different date, query age should be
0 at the time it gets an opened status and increment the longer it remains open. - For answered queries, reopened queries, and reopened queries with subsequent answers, as long as the status is still opened, query age should indicate how many days have passed since it was first opened until the current system's date.
- Closed Record: Indicates how long the query was open, from the first opened date to the date it was closed.
- Audit (Version-Ended) Record: Indicates the duration that each version of a query was active, measured from when it was opened to when that particular version ended.
|
\n QUERY_COMMENT | VARCHAR2(2048 CHAR) | Indicates a comment associated with a query, as entered by the user who last modified the query. |
\n ASSIGNED_ROLES | VARCHAR2(32767 CHAR) | Indicates the roles that are assigned to receive a query. |
\n IS_AUTO_QUERY | VARCHAR2(1 CHAR) | Indicates whether this is an automated query. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit trail metadata that explains when the row version became effective, who changed it, and whether it is current.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(20 CHAR) | Comment for record change. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(32 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(32 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(32 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(32 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(32 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n QUERY_ID | RAW(32 BYTE) | GUID of the query. |
\n QUERY_WID | NUMBER(10) | A number that represents the unique identifier of the query. |
\n USER_ID | RAW(32 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent record. |
\n PARENT_WID | NUMBER(10) | Indicates the numeric identifier of the parent record. A sentinel value of -1 can appear when no parent record applies. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root record. |
\n ROOT_WID | NUMBER(10) | Indicates the numeric identifier of the root record. A sentinel value of -1 can appear when no root record applies. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Indicates the number of times the form has been repeated. |
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the number of times the event has been repeated for the subject. |
\n TRANSACTION_START | DATE | Indicates the transaction start date associated with the queried subject form item record. |
\n TRANSACTION_END | DATE | Indicates the transaction end date associated with the queried subject form item record. |
\n STATE_ID | NUMBER | A number that represents the unique identifier of the query state. |
\n RULE_ID | RAW(32 BYTE) | GUID of the rule. |
\n DISCREPANCY_ID | NUMBER(38) | Indicates the discrepancy identifier associated with the query. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | GUID of the subject form item record associated with the queried data element. |
\n VARIABLE_ID | RAW(16 BYTE) | GUID of the variable. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Indicates the date and time when the referenced property version became effective. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form item record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of the normalized unit. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally as the underlying query dataset row is versioned. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"QueryDataSetReport":{
"description":"QueryDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE"
],
"data":[
[
"3A06FA4026504D819D33D6061B0AF6AB",
"1",
"0",
"Candidate",
"please provide more details ",
"CE5F2D7A9B4C4D1E8F2A6C3B7D8E9A10",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"4F9D07D644904CEAB2F2DEFA02E8921C",
"2",
"DATAHUB_AUT_Site2_Active02",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"0",
"0",
"CF149710CBE24A6BB9266E52B5F5BA0F",
"618",
"Subject Initials",
"2025-10-30T17:02:09.726Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"2",
"Auto query created",
"Auto-created",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-30T17:04:02.544Z",
"1001",
"N",
"Y",
"Site CRA;Data Manager",
"0",
"6529F9EBEB914CED8DAED37B7C3DBCFA",
"41",
"FORM_02",
"6",
"2025-10-30T17:00:00.000Z",
"2025-10-30T17:02:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"ABC",
null,
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"2025-10-30T17:02:09.000Z",
"10",
"30",
"2025",
"17",
"02",
"09",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"ScreeningForm",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"ScreeningForm",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"ABC",
"ABC",
"TEXT",
"TEXT",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"FBDBB9C9A70C470E8E90B812460F00F8",
"2025-12-11T21:45:21.430Z",
"Enter subject initials",
"1",
"0",
"Subject_Initials",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"New",
"DATAHUB_AUT_Site2_Screen02",
"DATAHUB_AUT_Site2_Active02",
"COMPLETED",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"ScreeningForm",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"N",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"candidate",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14"
]
]
}
},
"QueryDataSetEmptyReport":{
"description":"QueryDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-queries-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-queries-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: IS_MISSING_ITEM.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"IS_MISSING_ITEM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | Numeric identifier of the parent record. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Designer-provided GUID that identifies the question within the form. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID for the subject event instance that owns this data. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event whose scheduled visit spawned this visit. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property that owns this data element. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"IS_MISSING_ITEM"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
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"0",
"0",
"0",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
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"10",
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"2025",
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"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
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"8",
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"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"Manual Entry"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"IS_MISSING_ITEM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: IS_MISSING_FORM.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"IS_MISSING_FORM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"IS_MISSING_FORM"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"N"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"IS_MISSING_FORM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: IS_MISSING_VISIT.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y for scheduled visits or N for unscheduled ones. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier that represents the treatment arm. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
[
"7550C1E7E3CA4B8CAD09ACD1F1E7F580",
"37",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"Tester2",
"United States",
"DATAHUB_AUT_Site2_Active13",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
"10007890",
"2025-10-29T17:00:00.000Z",
"1",
"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"50262",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"false",
"Dr.",
"true",
"true",
"true",
"1.0.0.3",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"SITE_STUDY_VERSION",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: IS_MISSING_VISIT.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedSubjectDataSetQuery_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
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"STUDY_WID",
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"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
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"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
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"100% SDV",
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"Reduced",
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},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
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"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
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"SUBJECT_NUMBER",
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"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
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"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER, FREEZE, VERIFIED, SIGNED, and EXTERNAL_SOURCE_STATUS_DATE.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveSubjectDataSetQuery_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n EXTERNAL_SOURCE_STATUS_DATE | TIMESTAMP(6) | Indicates the date on which the subject status was updated by an external source. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if the subject's data is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the aggregate verification status for the subject's data. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the subject. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Screen01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"N",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"Initial subject creation",
"Created via data hub load",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"N",
"N",
"N",
"2025-10-29T13:00:00.000Z",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v4.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
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\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
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\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
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\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
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\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
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\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(255 CHAR) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
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\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
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\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
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\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
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\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER(10) | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER(10) | Numeric identifier of the confirming user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER(10) | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"Site",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"Complete",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"19",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"0",
"0",
"1",
"Assigned",
"2025-10-29T17:31:09.030Z",
"MLOT1",
"BLT1",
"MLOT1",
"BLT1",
"2030-12-31T00:00:00.000Z",
"2026-12-31T00:00:00.000Z",
"10",
"0",
"10",
"0",
"9A8B7C6D5E4F4A1B8C7D6E5F4A3B2C1D",
"1001",
"SHIP-0002",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"TRK123999",
"1",
"Y",
"Week2",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"DISPENSATION",
"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
"28",
"0",
"2",
"0",
"2",
"0",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"Week3",
"WEEK3",
"Week3",
"1536",
"Device",
"ActivityWatch",
"DevicetoCloud",
"0",
"UNBLINDED",
"D26E345F8CBD44B6A22C666F11D1F04D",
"27",
"Device",
"DEVICE",
"1",
"1",
"0",
"N/A",
"0",
"0",
"0",
"424CA68C1E523E82E063BDD14C646211",
"255",
"50254",
"mHC2CDevice",
"Dispensed",
"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
"N/A",
"Once Daily",
"0",
"0",
"false",
"1",
"1",
"7E6D5C4B3A29100FEE12DDCCBBAA9988",
"0",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"0",
"70",
"2025-10-29T17:31:19.861Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"4",
"Data correction",
"Updated during data sync",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"Y",
"11223344556677889900AABBCCDDEEFF",
"88",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"A1B2C3D4E5F60718293A4B5C6D7E8F90",
"88",
"Site Pharmacist",
"2025-10-29T12:20:00.000Z",
"2",
"2025-10-29T17:32:35.284Z",
"BLK-0001",
"50262"
]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v4.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v4.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: ALERT_OUTSIDE_VISIT_WINDOW.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_17",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n ALERT_OUTSIDE_VISIT_WINDOW | VARCHAR2(16 CHAR) | Indicates if there is any rule set to alert if visit date is out of window. Values can be: |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_MULTIPLE_INSTANCES | NUMBER | Indicates whether multiple instances of the same form can be added within a visit. Possible values include 0 or 1. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767 CHAR) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ALLOW_FUTURE_DATE | NUMBER(1) | For Date/Time questions. Indicates if the user is allowed to enter a future date. Possible values include 0 or 1. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n VALIDATION_RULES | VARCHAR2(32767 CHAR) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | RAW(16 BYTE) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"DataCollectionDataSetReport":{
"description":"DataCollectionDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"3279AFB1AA3C44CFB6D6C419AAAC8A84",
"WEEK1",
"202",
"2",
"0",
"2",
"0",
"ALERT",
"21",
"0",
"864",
"5",
"301",
"Treatment Arm A",
"ARM_A",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"N",
"0",
"Y",
"N",
"Arm A",
"ELIGIBILITY_FORM",
"Eligible for Arm A?",
"Yes",
"Screening",
"3ADB1375C6714B8C97CA14AFA175D739",
"73",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"-1",
"N/A",
"-1",
"N/A",
"1.0",
"2025-01-01T00:00:00.000Z",
"0",
"0",
"8F70423FE2204ED5A3B0B00F363C3306",
"346",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"value>=0 and value<=300",
"Weight must be between 0 and 300 kg",
"OnChange:RecalculateBMI",
"N/A",
"REQUIRED",
"N",
"1",
"",
"",
"0",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"2025-10-29T13:09:36.312Z",
"testuser1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"{}"
]
]
}
},
"DataCollectionDataSetEmptyReport":{
"description":"DataCollectionDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/kitsAndRandomizations":{
"post":{
"tags":[
"Data Hub/Datasets/Get kits and randomization design data for study"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Kits and Randomization Design dataset for a single study.
The dataset exposes versioned randomization and supply design configuration, including study-event linkage, randomization definitions, treatment arms, titration and allocation settings, kit types, calculated dose configuration, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for randomization and kit design entities configured for the study versions available in the selected mode.
This version additionally includes the following data points: RANDOMIZATION_STRATEGY.
Required permission: KitsAndRandomizationDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, STUDYEVENT_ID, RAND_ID, ARM_ID, KIT_ID, SCHEDULED_FROM_EVENT_ID, and TITRATION in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_18",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"KitsAndRandomizationDataSetQuery":{
"description":"KitsAndRandomizationDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"STUDYEVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"RAND_ID",
"sortOrder":"ASC"
},
{
"columnName":"ARM_ID",
"sortOrder":"ASC"
},
{
"columnName":"KIT_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"TITRATION",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Randomization context | Event context | Kit context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer when they design the randomization in Study Design mode. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization. Possible values include Blinded or Unblinded. |
\n RANDOMIZATION_STRATEGY | VARCHAR2(32 CHAR) | Indicates the randomization strategy selected for the randomization design. Possible values include Central Stratified, Country Blocked Dynamic Stratified, Country Blocked Fixed Stratified, Site Blocked Dynamic Stratified, Region Blocked Fixed Stratified, or Region Blocked Dynamic Stratified. |
\n COHORT_NAME | VARCHAR2(32767 CHAR) | Indicates the cohort name, as specified by a study designer. |
\n COHORTTYPE | VARCHAR2(32 CHAR) | Indicates the type of cohort selected by a study designer when creating a randomization design: None, Adaptive, or Demography. Possible values include NoCohort, Adaptive, or Demography. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | The title of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | The ID of the treatment arm, as specified by the study designer when creating the arm. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n RANDOMIZATION_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the randomization data was entered. |
\n RANDOMIZATION_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when randomization data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-window attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | A visit's reference name used in the system. This value is composed by EVENT_TITLE converted to uppercase with blank spaces removed and once created it doesn't update. |
\n EVENT_TYPE | VARCHAR2(32) | The event type of the visit. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates the number of days before the event or activity should happen. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates the number of hours before the event or activity should happen. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates the number of days after the event or activity should happen. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates the number of hours after the event or activity should happen. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit design, supply configuration, and kit-type attributes associated with the study setup.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_TYPE | VARCHAR2(23) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include Blister Pack, Bottle, Device, Syringe, Topical Ointment, Vial, Inhaler, Infusion, Box, or Other. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates how one unit in the kit is measured, specifically its specified value. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculations defined based on subjects' answers to one or more questions. |
\n SERIALIZED | CHAR(1) | Indicates whether a kit is serialized or non-serialized. Possible values include Y or N. |
\n CONTROL_SUBSTANCE | CHAR(1) | Indicates whether a kit constitutes a controlled substance. Possible values include Y or N. |
\n HAZARDOUS_MATERIAL | CHAR(1) | Indicates whether a kit contains hazardous materials. Possible values include Y or N. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include Activity Watch, Blood Pressure Monitor, Glucose Monitor, Weight Scale, ECG Reader, Spirometer, Mobile App, Smart Pill Bottle, Pulse Oximeter, Wearable Patch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. Possible values include Blinded, Unblinded, or Unblinded Pharmacist. |
\n KIT_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the kit data was entered. |
\n KIT_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when kit data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose definitions and dosing rules configured for kit supply design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n DOSING_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n PERCISION_FOR_EACH_DOSE | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n ROUND_UP_FOR | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. |
\n USE_LEFTOVER_UNITS_IN_NEXT_DOSE | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata captured with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | The user who last modify the study. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n RAND_ID | RAW(16 BYTE) | GUID of the randomization design. |
\n RAND_WID | NUMBER | A number that represents the unique identifier of the randomization design. |
\n ARM_ID | RAW(16 BYTE) | GUID of the treatment arm. |
\n ARM_WID | NUMBER | A number that represents the unique identifier of the treatment arm. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | VARCHAR2(32767) | Identifier of the cohort selected in the randomization design. |
\n COHORT_WID | VARCHAR2(32767) | A number that represents the unique identifier of the cohort. |
\n STUDYEVENT_ID | RAW(16 BYTE) | GUID of the study event. |
\n STUDYEVENT_WID | NUMBER(10) | A number that represents the unique identifier of the study event. |
\n KIT_ID | RAW(16 BYTE) | GUID of the kit. |
\n KIT_WID | NUMBER(10) | A number that represents the unique identifier of the kit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"KitsAndRandomizationDataSetReport":{
"description":"KitsAndRandomizationDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"testuser1",
"APPROVED",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"26",
"1DAB0F8B8BB249FEBB686596C7598EB1",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"NoCohort",
"1",
"2025-10-29T12:34:57.563Z",
"19",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"1",
"0",
"2025-10-29T12:20:42.956Z",
"3099-12-31T00:00:00.000Z",
"COHORT_1",
"101",
"Default Cohort",
"Y",
"Y",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"ScheduleAbleVisit",
"ONSITE",
"28",
"0",
"2",
"0",
"2",
"0",
"Week3",
"WEEK3",
"Week3",
"1536",
"116",
"5A05BF29727D48D5BBB108991017CF98",
"Connected Syringe Pump",
"BLE",
"0",
"BLINDED",
"SyringeKit",
"SYRINGE",
"1",
"1",
"5.00",
"mL",
"0",
"2025-10-29T12:14:23.304Z",
"3099-12-31T00:00:00.000Z",
"Y",
"N",
"N",
"Investigational Product",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"10.00",
"70.00",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"Central"
]
]
}
},
"KitsAndRandomizationDataSetEmptyReport":{
"description":"KitsAndRandomizationDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-kitsAndRandomizations-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-kitsandrandomizations-post"
}
},
"/ec-datahub-svc/rest/v5.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions. This version of the extract additionally includes labId and labName in FormData, and queryType, assignedRole, and queryRaised in Query transactions. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v5.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v5.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions. This version of the extract additionally includes labId and labName in FormData, and queryType, assignedRole, and queryRaised in Query transactions. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v5.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v5.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract meta data in CDISC ODM-XML format.",
"operationId":"getMetadata_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v5.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/{mode}/queries":{
"post":{
"tags":[
"Data Hub/Datasets/Get queries raised for study"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Queries dataset for a single study and mode.
The dataset exposes query lifecycle history raised against clinical data, including query state and comments, rule context, study, site, subject, visit, form, and item context, together with audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns query-history rows for the selected study and mode, not only currently open queries.
This version additionally includes the following data points: CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: StudyQueryDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and QUERY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_19",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"QueryDataSetQuery":{
"description":"QueryDataSetQuery",
"value":{
"selectColumns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"QUERY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Subject context | Event context | Form context | Item context | Query context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. Possible values include 1.3.0.8 or 5.3.0.16. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. Possible values include America/New_York or Asia/Kolkata. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit scheduling, status, and execution attributes associated with the queried record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.NOT_STARTED: the visit has not been started.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. Possible values include 0, 1, or 7. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design, repeat, and status attributes associated with the queried data element.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only receive this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nItem-level values, validation output, derived representations, and item metadata associated with the query.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. Possible values include TEXT, DATETIME, NUMERIC, CHOICE, LABEL, or FILE_UPLOAD. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, label, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Oracle Clinical One Platform integrations. |
\n FORMITEM_IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. Possible values include 0 or 1. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include 0 or 1. |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nQuery context
\nQuery lifecycle fields that describe the discrepancy, its state, ownership, and query-specific classification.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n QUERY_TYPE | VARCHAR2(16 CHAR) | Indicates the query type. |
\n STATE | VARCHAR2(255 CHAR) | Indicates a query's status: OpenedAnsweredClosedCandidate query
|
\n QUERYAGE | NUMBER | Indicates the number of days passed since a query was first opened. - Current (Active) Record: Indicates how many days have passed since the query was first opened until today while it remains open. This means query age should be
0 when the query gets an opened status and increment the longer it remains open. - For candidate and deleted queries, query age should be always
0. - For candidate queries created on one date and opened on a different date, query age should be
0 at the time it gets an opened status and increment the longer it remains open. - For answered queries, reopened queries, and reopened queries with subsequent answers, as long as the status is still opened, query age should indicate how many days have passed since it was first opened until the current system's date.
- Closed Record: Indicates how long the query was open, from the first opened date to the date it was closed.
- Audit (Version-Ended) Record: Indicates the duration that each version of a query was active, measured from when it was opened to when that particular version ended.
|
\n QUERY_COMMENT | VARCHAR2(2048 CHAR) | Indicates a comment associated with a query, as entered by the user who last modified the query. |
\n ASSIGNED_ROLES | VARCHAR2(32767 CHAR) | Indicates the roles that are assigned to receive a query. |
\n IS_AUTO_QUERY | VARCHAR2(1 CHAR) | Indicates whether this is an automated query. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit trail metadata that explains when the row version became effective, who changed it, and whether it is current.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(20 CHAR) | Comment for record change. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(32 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(32 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(32 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(32 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(32 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n QUERY_ID | RAW(32 BYTE) | GUID of the query. |
\n QUERY_WID | NUMBER(10) | A number that represents the unique identifier of the query. |
\n USER_ID | RAW(32 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent record. |
\n PARENT_WID | NUMBER(10) | Indicates the numeric identifier of the parent record. A sentinel value of -1 can appear when no parent record applies. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root record. |
\n ROOT_WID | NUMBER(10) | Indicates the numeric identifier of the root record. A sentinel value of -1 can appear when no root record applies. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Indicates the number of times the form has been repeated. |
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the number of times the event has been repeated for the subject. |
\n TRANSACTION_START | DATE | Indicates the transaction start date associated with the queried subject form item record. |
\n TRANSACTION_END | DATE | Indicates the transaction end date associated with the queried subject form item record. |
\n STATE_ID | NUMBER | A number that represents the unique identifier of the query state. |
\n RULE_ID | RAW(32 BYTE) | GUID of the rule. |
\n DISCREPANCY_ID | NUMBER(38) | Indicates the discrepancy identifier associated with the query. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | GUID of the subject form item record associated with the queried data element. |
\n VARIABLE_ID | RAW(16 BYTE) | GUID of the variable. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Indicates the date and time when the referenced property version became effective. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form item record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of the normalized unit. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally as the underlying query dataset row is versioned. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"QueryDataSetReport":{
"description":"QueryDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
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"3A06FA4026504D819D33D6061B0AF6AB",
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"Subject Initials",
"2025-10-30T17:02:09.726Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"2",
"Auto query created",
"Auto-created",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-30T17:04:02.544Z",
"1001",
"N",
"Y",
"Site CRA;Data Manager",
"0",
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"41",
"FORM_02",
"6",
"2025-10-30T17:00:00.000Z",
"2025-10-30T17:02:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"ABC",
null,
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"10",
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"ScreeningForm",
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"ScreeningForm",
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"TEXT",
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"FBDBB9C9A70C470E8E90B812460F00F8",
"2025-12-11T21:45:21.430Z",
"Enter subject initials",
"1",
"0",
"Subject_Initials",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"New",
"DATAHUB_AUT_Site2_Screen02",
"DATAHUB_AUT_Site2_Active02",
"COMPLETED",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"ScreeningForm",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"N",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"candidate",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"27",
"N"
]
]
}
},
"QueryDataSetEmptyReport":{
"description":"QueryDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-{mode}-queries-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-mode-queries-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"IS_MISSING_ITEM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Indicates the question type as specified by the study designer. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID for the subject event instance that owns this data. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the item. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Decoded or display-friendly representation of the stored response. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
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"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"IS_MISSING_ITEM"
],
"data":[
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"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"Manual Entry"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"IS_MISSING_ITEM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
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"schema":{
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"USER_ID",
"USER_WID",
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"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
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"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
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"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM"
],
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"columns":[
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"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier that represents the treatment arm. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
[
"7550C1E7E3CA4B8CAD09ACD1F1E7F580",
"37",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
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"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
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"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
"10007890",
"2025-10-29T17:00:00.000Z",
"1",
"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"KIT-000457",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
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"test@abc.com",
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"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedSubjectDataSetQuery_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Screen01",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveSubjectDataSetQuery_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n EXTERNAL_SOURCE_STATUS_DATE | TIMESTAMP(6) | Indicates the date on which the subject status was updated by an external source. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if the subject's data is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the aggregate verification status for the subject's data. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the subject. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Screen01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"N",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"Initial subject creation",
"Created via data hub load",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"N",
"N",
"N",
"2025-10-29T13:00:00.000Z",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"1.0.0.3",
"false",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Dr.",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"PI_PREFIX",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v5.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: MATERIAL_ID, ITEM_NUMBER, CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n ITEM_NUMBER | VARCHAR2(64 CHAR) | Numeric value used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n MATERIAL_ID | VARCHAR2(64 CHAR) | Alphanumeric identifier of the material of a given kit, used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(255 CHAR) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER(10) | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER(10) | Numeric identifier of the confirming user. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER(10) | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
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"Site",
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"13",
"DATAHUB_AUT_Site2_Active13",
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"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
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"19",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"0",
"0",
"1",
"Assigned",
"2025-10-29T17:31:09.030Z",
"MLOT1",
"BLT1",
"MLOT1",
"BLT1",
"2030-12-31T00:00:00.000Z",
"2026-12-31T00:00:00.000Z",
"10",
"0",
"10",
"0",
"9A8B7C6D5E4F4A1B8C7D6E5F4A3B2C1D",
"1001",
"SHIP-0002",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"TRK123999",
"1",
"Y",
"Week2",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"DISPENSATION",
"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
"28",
"0",
"2",
"0",
"2",
"0",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"Week3",
"WEEK3",
"Week3",
"1536",
"Device",
"ActivityWatch",
"DevicetoCloud",
"0",
"UNBLINDED",
"D26E345F8CBD44B6A22C666F11D1F04D",
"27",
"Device",
"DEVICE",
"1",
"1",
"0",
"N/A",
"0",
"0",
"0",
"424CA68C1E523E82E063BDD14C646211",
"255",
"50254",
"mHC2CDevice",
"Dispensed",
"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
"N/A",
"Once Daily",
"0",
"0",
"false",
"1",
"1",
"7E6D5C4B3A29100FEE12DDCCBBAA9988",
"0",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"0",
"70",
"2025-10-29T17:31:19.861Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"4",
"Data correction",
"Updated during data sync",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"Y",
"11223344556677889900AABBCCDDEEFF",
"88",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"A1B2C3D4E5F60718293A4B5C6D7E8F90",
"88",
"Site Pharmacist",
"2025-10-29T12:20:00.000Z",
"2",
"2025-10-29T17:32:35.284Z",
"BLK-0001",
"50262",
"MAT-001",
"ITEM-001",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)"
]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v5.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v5.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"V6.0",
"description":"Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: EHR_MAPPING and OCC_ENABLED.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_20",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n OCC_ENABLED | CHAR(1) | Indicates if a study is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a study or if a study was disabled for EHR. Possible values include Y or N.
|
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n ALERT_OUTSIDE_VISIT_WINDOW | VARCHAR2(16 CHAR) | Indicates if there is any rule set to alert if visit date is out of window. Values can be: |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_MULTIPLE_INSTANCES | NUMBER | Indicates whether multiple instances of the same form can be added within a visit. Possible values include 0 or 1. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767 CHAR) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ALLOW_FUTURE_DATE | NUMBER(1) | For Date/Time questions. Indicates if the user is allowed to enter a future date. Possible values include 0 or 1. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n EHR_MAPPING | VARCHAR2(32767 CHAR) | Displays the OCC data dictionary mapping value for a question mapped for Electronic Health Record (EHR) data import. |
\n VALIDATION_RULES | VARCHAR2(32767 CHAR) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | RAW(16 BYTE) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"DataCollectionDataSetReport":{
"description":"DataCollectionDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
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"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
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"CURRENT_STUDY_ROLE_WID",
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],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"3279AFB1AA3C44CFB6D6C419AAAC8A84",
"WEEK1",
"202",
"2",
"0",
"2",
"0",
"ALERT",
"21",
"0",
"864",
"5",
"301",
"Treatment Arm A",
"ARM_A",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"N",
"0",
"Y",
"N",
"Arm A",
"ELIGIBILITY_FORM",
"Eligible for Arm A?",
"Yes",
"Screening",
"3ADB1375C6714B8C97CA14AFA175D739",
"73",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"-1",
"N/A",
"-1",
"N/A",
"1.0",
"2025-01-01T00:00:00.000Z",
"0",
"0",
"8F70423FE2204ED5A3B0B00F363C3306",
"346",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"value>=0 and value<=300",
"Weight must be between 0 and 300 kg",
"OnChange:RecalculateBMI",
"N/A",
"REQUIRED",
"N",
"1",
"",
"",
"0",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"2025-10-29T13:09:36.312Z",
"testuser1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"{}",
"N",
"Y"
]
]
}
},
"DataCollectionDataSetEmptyReport":{
"description":"DataCollectionDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
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"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
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"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/kitsAndRandomizations":{
"post":{
"tags":[
"Data Hub/Datasets/Get kits and randomization design data for study"
],
"summary":"V6.0",
"description":"Retrieves the study-permissioned Kits and Randomization Design dataset for a single study.
The dataset exposes versioned randomization and supply design configuration, including study-event linkage, randomization definitions, treatment arms, titration and allocation settings, kit types, calculated dose configuration, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for randomization and kit design entities configured for the study versions available in the selected mode.
This version additionally includes the following data points: AD_GROUP_ID.
Required permission: KitsAndRandomizationDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, STUDYEVENT_ID, RAND_ID, ARM_ID, KIT_ID, SCHEDULED_FROM_EVENT_ID, TITRATION, and AD_GROUP_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_21",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"KitsAndRandomizationDataSetQuery":{
"description":"KitsAndRandomizationDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY",
"AD_GROUP_ID"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"STUDYEVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"RAND_ID",
"sortOrder":"ASC"
},
{
"columnName":"ARM_ID",
"sortOrder":"ASC"
},
{
"columnName":"KIT_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"TITRATION",
"sortOrder":"ASC"
},
{
"columnName":"AD_GROUP_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Randomization context | Event context | Kit context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer when they design the randomization in Study Design mode. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization. Possible values include Blinded or Unblinded. |
\n RANDOMIZATION_STRATEGY | VARCHAR2(32 CHAR) | Indicates the randomization strategy selected for the randomization design. Possible values include Central Stratified, Country Blocked Dynamic Stratified, Country Blocked Fixed Stratified, Site Blocked Dynamic Stratified, Region Blocked Fixed Stratified, or Region Blocked Dynamic Stratified. |
\n COHORT_NAME | VARCHAR2(32767 CHAR) | Indicates the cohort name, as specified by a study designer. |
\n COHORTTYPE | VARCHAR2(32 CHAR) | Indicates the type of cohort selected by a study designer when creating a randomization design: None, Adaptive, or Demography. Possible values include NoCohort, Adaptive, or Demography. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | The title of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | The ID of the treatment arm, as specified by the study designer when creating the arm. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n AD_GROUP_ID | RAW(16 BYTE) | GUID of the adaptive design group associated with the kit allocation configuration. |
\n RANDOMIZATION_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the randomization data was entered. |
\n RANDOMIZATION_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when randomization data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-window attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | A visit's reference name used in the system. This value is composed by EVENT_TITLE converted to uppercase with blank spaces removed and once created it doesn't update. |
\n EVENT_TYPE | VARCHAR2(32) | The event type of the visit. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates the number of days before the event or activity should happen. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates the number of hours before the event or activity should happen. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates the number of days after the event or activity should happen. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates the number of hours after the event or activity should happen. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit design, supply configuration, and kit-type attributes associated with the study setup.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_TYPE | VARCHAR2(23) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include Blister Pack, Bottle, Device, Syringe, Topical Ointment, Vial, Inhaler, Infusion, Box, or Other. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates how one unit in the kit is measured, specifically its specified value. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculations defined based on subjects' answers to one or more questions. |
\n SERIALIZED | CHAR(1) | Indicates whether a kit is serialized or non-serialized. Possible values include Y or N. |
\n CONTROL_SUBSTANCE | CHAR(1) | Indicates whether a kit constitutes a controlled substance. Possible values include Y or N. |
\n HAZARDOUS_MATERIAL | CHAR(1) | Indicates whether a kit contains hazardous materials. Possible values include Y or N. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include Activity Watch, Blood Pressure Monitor, Glucose Monitor, Weight Scale, ECG Reader, Spirometer, Mobile App, Smart Pill Bottle, Pulse Oximeter, Wearable Patch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. Possible values include Blinded, Unblinded, or Unblinded Pharmacist. |
\n KIT_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the kit data was entered. |
\n KIT_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when kit data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose definitions and dosing rules configured for kit supply design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n DOSING_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n PERCISION_FOR_EACH_DOSE | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n ROUND_UP_FOR | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. |
\n USE_LEFTOVER_UNITS_IN_NEXT_DOSE | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata captured with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | The user who last modify the study. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n RAND_ID | RAW(16 BYTE) | GUID of the randomization design. |
\n RAND_WID | NUMBER | A number that represents the unique identifier of the randomization design. |
\n ARM_ID | RAW(16 BYTE) | GUID of the treatment arm. |
\n ARM_WID | NUMBER | A number that represents the unique identifier of the treatment arm. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | VARCHAR2(32767) | Identifier of the cohort selected in the randomization design. |
\n COHORT_WID | VARCHAR2(32767) | A number that represents the unique identifier of the cohort. |
\n STUDYEVENT_ID | RAW(16 BYTE) | GUID of the study event. |
\n STUDYEVENT_WID | NUMBER(10) | A number that represents the unique identifier of the study event. |
\n KIT_ID | RAW(16 BYTE) | GUID of the kit. |
\n KIT_WID | NUMBER(10) | A number that represents the unique identifier of the kit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"KitsAndRandomizationDataSetReport":{
"description":"KitsAndRandomizationDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY",
"AD_GROUP_ID"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"testuser1",
"APPROVED",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"26",
"1DAB0F8B8BB249FEBB686596C7598EB1",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"NoCohort",
"1",
"2025-10-29T12:34:57.563Z",
"19",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"1",
"0",
"2025-10-29T12:20:42.956Z",
"3099-12-31T00:00:00.000Z",
"COHORT_1",
"101",
"Default Cohort",
"Y",
"Y",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"ScheduleAbleVisit",
"ONSITE",
"28",
"0",
"2",
"0",
"2",
"0",
"Week3",
"WEEK3",
"Week3",
"1536",
"116",
"5A05BF29727D48D5BBB108991017CF98",
"Connected Syringe Pump",
"BLE",
"0",
"BLINDED",
"SyringeKit",
"SYRINGE",
"1",
"1",
"5.00",
"mL",
"0",
"2025-10-29T12:14:23.304Z",
"3099-12-31T00:00:00.000Z",
"Y",
"N",
"N",
"Investigational Product",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"10.00",
"70.00",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"Central",
"00000000000000000000000000000000"
]
]
}
},
"KitsAndRandomizationDataSetEmptyReport":{
"description":"KitsAndRandomizationDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PERCISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY",
"AD_GROUP_ID"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-kitsAndRandomizations-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-kitsandrandomizations-post"
}
},
"/ec-datahub-svc/rest/v6.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions, labId and labName in FormData, and queryType, assignedRole, and queryRaised in Query transactions. This version of the extract additionally includes form association data. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v6.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v6.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in CDISC ODM-XML format. This extract includes subject, visit, and item level transactions, labId and labName in FormData, and queryType, assignedRole, and queryRaised in Query transactions. This version of the extract additionally includes form association data. If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v6.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v6.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract meta data in the CDISC ODM-XML format. This version introduces a new clinical one extension attribute for the alert outside visit window property",
"operationId":"getMetadata_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v6.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/{mode}/queries":{
"post":{
"tags":[
"Data Hub/Datasets/Get queries raised for study"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Queries dataset for a single study and mode.
The dataset exposes query lifecycle history raised against clinical data, including query state and comments, rule context, study, site, subject, visit, form, and item context, together with audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns query-history rows for the selected study and mode, not only currently open queries.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_REFNAME.
Required permission: StudyQueryDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and QUERY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_22",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"QueryDataSetQuery":{
"description":"QueryDataSetQuery",
"value":{
"selectColumns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"QUERY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Subject context | Event context | Form context | Item context | Query context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. Possible values include 1.3.0.8 or 5.3.0.16. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. Possible values include America/New_York or Asia/Kolkata. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit scheduling, status, and execution attributes associated with the queried record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.NOT_STARTED: the visit has not been started.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. Possible values include 0, 1, or 7. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design, repeat, and status attributes associated with the queried data element.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only receive this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nItem-level values, validation output, derived representations, and item metadata associated with the query.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. Possible values include TEXT, DATETIME, NUMERIC, CHOICE, LABEL, or FILE_UPLOAD. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, label, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Oracle Clinical One Platform integrations. |
\n FORMITEM_IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. Possible values include 0 or 1. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include 0 or 1. |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER(10) | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nQuery context
\nQuery lifecycle fields that describe the discrepancy, its state, ownership, and query-specific classification.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n QUERY_TYPE | VARCHAR2(16 CHAR) | Indicates the query type. |
\n STATE | VARCHAR2(255 CHAR) | Indicates a query's status: OpenedAnsweredClosedCandidate query
|
\n QUERYAGE | NUMBER | Indicates the number of days passed since a query was first opened. - Current (Active) Record: Indicates how many days have passed since the query was first opened until today while it remains open. This means query age should be
0 when the query gets an opened status and increment the longer it remains open. - For candidate and deleted queries, query age should be always
0. - For candidate queries created on one date and opened on a different date, query age should be
0 at the time it gets an opened status and increment the longer it remains open. - For answered queries, reopened queries, and reopened queries with subsequent answers, as long as the status is still opened, query age should indicate how many days have passed since it was first opened until the current system's date.
- Closed Record: Indicates how long the query was open, from the first opened date to the date it was closed.
- Audit (Version-Ended) Record: Indicates the duration that each version of a query was active, measured from when it was opened to when that particular version ended.
|
\n QUERY_COMMENT | VARCHAR2(2048 CHAR) | Indicates a comment associated with a query, as entered by the user who last modified the query. |
\n ASSIGNED_ROLES | VARCHAR2(32767 CHAR) | Indicates the roles that are assigned to receive a query. |
\n IS_AUTO_QUERY | VARCHAR2(1 CHAR) | Indicates whether this is an automated query. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit trail metadata that explains when the row version became effective, who changed it, and whether it is current.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(20 CHAR) | Comment for record change. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(32 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(32 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(32 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(32 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(32 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n QUERY_ID | RAW(32 BYTE) | GUID of the query. |
\n QUERY_WID | NUMBER(10) | A number that represents the unique identifier of the query. |
\n USER_ID | RAW(32 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent record. |
\n PARENT_WID | NUMBER(10) | Indicates the numeric identifier of the parent record. A sentinel value of -1 can appear when no parent record applies. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root record. |
\n ROOT_WID | NUMBER(10) | Indicates the numeric identifier of the root record. A sentinel value of -1 can appear when no root record applies. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Indicates the number of times the form has been repeated. |
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the number of times the event has been repeated for the subject. |
\n TRANSACTION_START | DATE | Indicates the transaction start date associated with the queried subject form item record. |
\n TRANSACTION_END | DATE | Indicates the transaction end date associated with the queried subject form item record. |
\n STATE_ID | NUMBER | A number that represents the unique identifier of the query state. |
\n RULE_ID | RAW(32 BYTE) | GUID of the rule. |
\n DISCREPANCY_ID | NUMBER(38) | Indicates the discrepancy identifier associated with the query. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | GUID of the subject form item record associated with the queried data element. |
\n VARIABLE_ID | RAW(16 BYTE) | GUID of the variable. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Indicates the date and time when the referenced property version became effective. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER(10) | A number that represents the unique identifier of the subject form item record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of the normalized unit. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally as the underlying query dataset row is versioned. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"QueryDataSetReport":{
"description":"QueryDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"3A06FA4026504D819D33D6061B0AF6AB",
"1",
"0",
"Candidate",
"please provide more details ",
"CE5F2D7A9B4C4D1E8F2A6C3B7D8E9A10",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"4F9D07D644904CEAB2F2DEFA02E8921C",
"2",
"DATAHUB_AUT_Site2_Active02",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"0",
"0",
"CF149710CBE24A6BB9266E52B5F5BA0F",
"618",
"Subject Initials",
"2025-10-30T17:02:09.726Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"2",
"Auto query created",
"Auto-created",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-30T17:04:02.544Z",
"1001",
"N",
"Y",
"Site CRA;Data Manager",
"0",
"6529F9EBEB914CED8DAED37B7C3DBCFA",
"41",
"FORM_02",
"6",
"2025-10-30T17:00:00.000Z",
"2025-10-30T17:02:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"ABC",
null,
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"2025-10-30T17:02:09.000Z",
"10",
"30",
"2025",
"17",
"02",
"09",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"ScreeningForm",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"ScreeningForm",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"ABC",
"ABC",
"TEXT",
"TEXT",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"FBDBB9C9A70C470E8E90B812460F00F8",
"2025-12-11T21:45:21.430Z",
"Enter subject initials",
"1",
"0",
"Subject_Initials",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"New",
"DATAHUB_AUT_Site2_Screen02",
"DATAHUB_AUT_Site2_Active02",
"COMPLETED",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"ScreeningForm",
"SCREENINGFORM",
"INPROGRESS",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"N",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"candidate",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"27",
"N"
]
]
}
},
"QueryDataSetEmptyReport":{
"description":"QueryDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-{mode}-queries-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-mode-queries-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: LAB_ID and LAB_NAME.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"IS_MISSING_ITEM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | Flags rows that describe a missing question or item value. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Indicates the question type as specified by the study designer. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID for the subject event instance that owns this data. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the item. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Indicates the row position of the item. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"IS_MISSING_ITEM"
],
"data":[
[
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"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"DATAHUB_AUT_Site2_Screen07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
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"0",
"0",
"0",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"Manual Entry"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"IS_MISSING_ITEM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: ASSOCIATED_FORM_SECTION_ID, ASSOCIATED_REPEAT_FORM_NUM, CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: TITRATION, TREATMENT_ARM_TITLE, TREATMENT_ARM_DESCRIPTION, UNBLIND_DATE, UNBLIND_REASON, and UNBLIND_COMMENT.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n UNBLIND_DATE | TIMESTAMP(6) | Indicates the date and time when the first code break was performed and the subject's treatment arm was unblinded. This value is a timestamp. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date. |
\n UNBLIND_REASON | VARCHAR2(255 CHAR) | Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason. |
\n UNBLIND_COMMENT | VARCHAR2(2048 CHAR) | Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier that represents the treatment arm. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"IS_MISSING_VISIT"
],
"data":[
[
"7550C1E7E3CA4B8CAD09ACD1F1E7F580",
"37",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"Tester2",
"United States",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
"10007890",
"2025-10-29T17:00:00.000Z",
"1",
"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"KIT-000457",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N",
"0",
"Treatment Arm A",
"Arm A dosing schedule",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedSubjectDataSetQuery_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Screen01",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: SCREENING_NUMBER.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveSubjectDataSetQuery_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n EXTERNAL_SOURCE_STATUS_DATE | TIMESTAMP(6) | Indicates the date on which the subject status was updated by an external source. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if the subject's data is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the aggregate verification status for the subject's data. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the subject. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Screen01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"N",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"Initial subject creation",
"Created via data hub load",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"DATAHUB_AUT_Site2_Active01",
"N",
"N",
"N",
"2025-10-29T13:00:00.000Z",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v6.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_REFNAME.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n ITEM_NUMBER | VARCHAR2(64 CHAR) | Numeric value used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n MATERIAL_ID | VARCHAR2(64 CHAR) | Alphanumeric identifier of the material of a given kit, used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(255 CHAR) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER(10) | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER(10) | Numeric identifier of the confirming user. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER(10) | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
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"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
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"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
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"DATAHUB_AUT_Site2_Active13",
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"0",
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"MLOT1",
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"2025-11-26T00:00:00.000Z",
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},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
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"columns":[
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"STUDY_ID_NAME",
"STUDY_TITLE",
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"STUDY_PHASE",
"BLINDING_TYPE",
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"DEA_NUMBER",
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"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v6.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v6.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"V7.0",
"description":"Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: REQ_SCREENING, REQ_RANDOMIZE, REQ_DISPENSE, and SAFETY_INTEGRATION_ENABLED.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_23",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n REQ_SCREENING | CHAR(1) | Indicates if the question is required for screening. Possible values include Y or N. |
\n REQ_RANDOMIZE | CHAR(1) | Indicates if the question is required for randomization. Possible values include Y or N. |
\n REQ_DISPENSE | CHAR(1) | Indicates if the question is required for dispensation. Possible values include Y or N. |
\n OCC_ENABLED | CHAR(1) | Indicates if a study is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a study or if a study was disabled for EHR. Possible values include Y or N.
|
\n SAFETY_INTEGRATION_ENABLED | CHAR(1) | Indicates if the Clinical One Cloud Service to Safety integration is enabled for the study. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n ALERT_OUTSIDE_VISIT_WINDOW | VARCHAR2(16 CHAR) | Indicates if there is any rule set to alert if visit date is out of window. Values can be: |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_MULTIPLE_INSTANCES | NUMBER | Indicates whether multiple instances of the same form can be added within a visit. Possible values include 0 or 1. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767 CHAR) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ALLOW_FUTURE_DATE | NUMBER(1) | For Date/Time questions. Indicates if the user is allowed to enter a future date. Possible values include 0 or 1. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n EHR_MAPPING | VARCHAR2(32767 CHAR) | Displays the OCC data dictionary mapping value for a question mapped for Electronic Health Record (EHR) data import. |
\n VALIDATION_RULES | VARCHAR2(32767 CHAR) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | RAW(16 BYTE) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"DataCollectionDataSetReport":{
"description":"DataCollectionDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"1.0.0.1",
"APPROVED",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"Y",
"Week1",
"3279AFB1AA3C44CFB6D6C419AAAC8A84",
"WEEK1",
"202",
"2",
"0",
"2",
"0",
"ALERT",
"21",
"0",
"864",
"5",
"301",
"Treatment Arm A",
"ARM_A",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"N",
"0",
"Y",
"N",
"Arm A",
"ELIGIBILITY_FORM",
"Eligible for Arm A?",
"Yes",
"Screening",
"3ADB1375C6714B8C97CA14AFA175D739",
"73",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"-1",
"N/A",
"-1",
"N/A",
"1.0",
"2025-01-01T00:00:00.000Z",
"0",
"0",
"8F70423FE2204ED5A3B0B00F363C3306",
"346",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"value>=0 and value<=300",
"Weight must be between 0 and 300 kg",
"OnChange:RecalculateBMI",
"N/A",
"REQUIRED",
"N",
"1",
"",
"",
"0",
"2025-10-29T13:03:20.263Z",
"3099-12-31T00:00:00.000Z",
"2025-10-29T13:09:36.312Z",
"testuser1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"{}",
"N",
"Y",
"N",
"N",
"N",
"N"
]
]
}
},
"DataCollectionDataSetEmptyReport":{
"description":"DataCollectionDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/kitsAndRandomizations":{
"post":{
"tags":[
"Data Hub/Datasets/Get kits and randomization design data for study"
],
"summary":"V7.0",
"description":"Retrieves the study-permissioned Kits and Randomization Design dataset for a single study.
The dataset exposes versioned randomization and supply design configuration, including study-event linkage, randomization definitions, treatment arms, titration and allocation settings, kit types, calculated dose configuration, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for randomization and kit design entities configured for the study versions available in the selected mode.
This version additionally includes the following data points: PRECISION_FOR_EACH_DOSE. It also retains the legacy PERCISION_FOR_EACH_DOSE column for backward compatibility and should be treated as obsolete.
Required permission: KitsAndRandomizationDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, STUDYEVENT_ID, RAND_ID, ARM_ID, KIT_ID, SCHEDULED_FROM_EVENT_ID, TITRATION, and AD_GROUP_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_24",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"EC942244BB30163BE053BEC44C64CF34"
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"KitsAndRandomizationDataSetQuery":{
"description":"KitsAndRandomizationDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PRECISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY",
"AD_GROUP_ID"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"STUDYEVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"RAND_ID",
"sortOrder":"ASC"
},
{
"columnName":"ARM_ID",
"sortOrder":"ASC"
},
{
"columnName":"KIT_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"TITRATION",
"sortOrder":"ASC"
},
{
"columnName":"AD_GROUP_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Randomization context | Event context | Kit context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer when they design the randomization in Study Design mode. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization. Possible values include Blinded or Unblinded. |
\n RANDOMIZATION_STRATEGY | VARCHAR2(32 CHAR) | Indicates the randomization strategy selected for the randomization design. Possible values include Central Stratified, Country Blocked Dynamic Stratified, Country Blocked Fixed Stratified, Site Blocked Dynamic Stratified, Region Blocked Fixed Stratified, or Region Blocked Dynamic Stratified. |
\n COHORT_NAME | VARCHAR2(32767 CHAR) | Indicates the cohort name, as specified by a study designer. |
\n COHORTTYPE | VARCHAR2(32 CHAR) | Indicates the type of cohort selected by a study designer when creating a randomization design: None, Adaptive, or Demography. Possible values include NoCohort, Adaptive, or Demography. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | The title of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | The description of the treatment arm, as specified by the study designer when creating the arm. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | The ID of the treatment arm, as specified by the study designer when creating the arm. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n AD_GROUP_ID | RAW(16 BYTE) | GUID of the adaptive design group associated with the kit allocation configuration. |
\n RANDOMIZATION_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the randomization data was entered. |
\n RANDOMIZATION_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when randomization data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, scheduling rules, and visit-window attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | A visit's reference name used in the system. This value is composed by EVENT_TITLE converted to uppercase with blank spaces removed and once created it doesn't update. |
\n EVENT_TYPE | VARCHAR2(32) | The event type of the visit. |
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates the number of days before the event or activity should happen. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates the number of hours before the event or activity should happen. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates the number of days after the event or activity should happen. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates the number of hours after the event or activity should happen. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit design, supply configuration, and kit-type attributes associated with the study setup.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_TYPE | VARCHAR2(23) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. Possible values include Blister Pack, Bottle, Device, Syringe, Topical Ointment, Vial, Inhaler, Infusion, Box, or Other. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates how one unit in the kit is measured, specifically its specified value. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculations defined based on subjects' answers to one or more questions. |
\n SERIALIZED | CHAR(1) | Indicates whether a kit is serialized or non-serialized. Possible values include Y or N. |
\n CONTROL_SUBSTANCE | CHAR(1) | Indicates whether a kit constitutes a controlled substance. Possible values include Y or N. |
\n HAZARDOUS_MATERIAL | CHAR(1) | Indicates whether a kit contains hazardous materials. Possible values include Y or N. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. Possible values include Activity Watch, Blood Pressure Monitor, Glucose Monitor, Weight Scale, ECG Reader, Spirometer, Mobile App, Smart Pill Bottle, Pulse Oximeter, Wearable Patch, or Other. |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. Possible values include Blinded, Unblinded, or Unblinded Pharmacist. |
\n KIT_VERSION_START | TIMESTAMP(6) | Indicates the date and time of when the kit data was entered. |
\n KIT_VERSION_END | TIMESTAMP(6) | Indicates the date and time of when kit data was changed, if the data is not current. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose definitions and dosing rules configured for kit supply design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n DOSING_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n [Obsolete]PERCISION_FOR_EACH_DOSE | NUMBER | Nullable | 2 | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n PRECISION_FOR_EACH_DOSE | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n ROUND_UP_FOR | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. |
\n USE_LEFTOVER_UNITS_IN_NEXT_DOSE | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata captured with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | The user who last modify the study. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n RAND_ID | RAW(16 BYTE) | GUID of the randomization design. |
\n RAND_WID | NUMBER | A number that represents the unique identifier of the randomization design. |
\n ARM_ID | RAW(16 BYTE) | GUID of the treatment arm. |
\n ARM_WID | NUMBER | A number that represents the unique identifier of the treatment arm. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | VARCHAR2(32767) | Identifier of the cohort selected in the randomization design. |
\n COHORT_WID | VARCHAR2(32767) | A number that represents the unique identifier of the cohort. |
\n STUDYEVENT_ID | RAW(16 BYTE) | GUID of the study event. |
\n STUDYEVENT_WID | NUMBER(10) | A number that represents the unique identifier of the study event. |
\n KIT_ID | RAW(16 BYTE) | GUID of the kit. |
\n KIT_WID | NUMBER(10) | A number that represents the unique identifier of the kit. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
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"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"MODIFIED_BY",
"STUDY_DESIGN_STATUS",
"VERSION_START",
"VERSION_END",
"RAND_WID",
"RAND_ID",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORTTYPE",
"RERANDOMIZATION",
"DH_TIMESTAMP",
"ARM_WID",
"ARM_ID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RANDOMIZATION_VERSION_START",
"RANDOMIZATION_VERSION_END",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"STUDYEVENT_ID",
"STUDYEVENT_WID",
"VISIT_TYPE",
"EVENT_TYPE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_HOUR_SEQ_ORDER",
"KIT_WID",
"KIT_ID",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_TYPE_ID",
"TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"TITRATION",
"KIT_VERSION_START",
"KIT_VERSION_END",
"SERIALIZED",
"HAZARDOUS_MATERIAL",
"CONTROL_SUBSTANCE",
"KIT_TYPE",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"PRECISION_FOR_EACH_DOSE",
"ROUND_UP_FOR",
"DOSING_FREQUENCY",
"USE_LEFTOVER_UNITS_IN_NEXT_DOSE",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"RANDOMIZATION_STRATEGY",
"AD_GROUP_ID"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-kitsAndRandomizations-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-kitsandrandomizations-post"
}
},
"/ec-datahub-svc/rest/v7.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds Screening Number as a new clinical one extension attribute at the subject level and includes visit date queries as transactions at the visit level. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v7.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v7.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds Screening Number as a new clinical one extension attribute at the subject level and includes visit date queries as transactions at the visit level. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v7.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v7.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract meta data in the CDISC ODM-XML format. This version introduces a new clinical one extension attribute 'EHRMapping' if an item is mapped to an EHR item.",
"operationId":"getMetadata_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string"
}
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v7.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/{mode}/queries":{
"post":{
"tags":[
"Data Hub/Datasets/Get queries raised for study"
],
"summary":"V7.0",
"description":"Retrieves the study-permissioned Queries dataset for a single study and mode.
The dataset exposes query lifecycle history raised against clinical data, including query state and comments, rule context, study, site, subject, visit, form, and item context, together with audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns query-history rows for the selected study and mode, not only currently open queries.
This version additionally includes the following data points: PROPERTY_NAME, PROPERTY_TYPE, SCREENING_NUMBER, and DATA_ELEMENT_VERSION_START.
Required permission: StudyQueryDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and QUERY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_25",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"QueryDataSetQuery":{
"description":"QueryDataSetQuery",
"value":{
"selectColumns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"PROPERTY_NAME",
"PROPERTY_TYPE",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"DATA_ELEMENT_VERSION_START"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"QUERY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Subject context | Event context | Form context | Item context | Query context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. Possible values include 1.3.0.8 or 5.3.0.16. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. Possible values include America/New_York or Asia/Kolkata. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit scheduling, status, and execution attributes associated with the queried record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.NOT_STARTED: the visit has not been started.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. Possible values include 0, 1, or 7. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design, repeat, and status attributes associated with the queried data element.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only receive this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nItem-level values, validation output, derived representations, and item metadata associated with the query.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. Possible values include TEXT, DATETIME, NUMERIC, CHOICE, LABEL, or FILE_UPLOAD. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, label, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Oracle Clinical One Platform integrations. |
\n FORMITEM_IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n READONLY | NUMBER | Indicates that the question is marked as read-only by a study designer. Possible values include 0 or 1. |
\n HIDDEN | NUMBER | Indicates if a question is hidden, as marked by a study designer. Possible values include 0 or 1. |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VALUE | VARCHAR2(16000) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(16000) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(16000) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(16000) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nQuery context
\nQuery lifecycle fields that describe the discrepancy, its state, ownership, and query-specific classification.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n PROPERTY_NAME | VARCHAR2(256 CHAR) | Name of the property to which the query is associated to. Note: This only applies to queries on visit dates and the default is visitStartDate. For other queries, this value is null. |
\n PROPERTY_TYPE | VARCHAR2(256 CHAR) | Type of property to which the query is associated to. Note: This only applies to queries on visit dates and the default is visit. For other queries, this value is null. |
\n QUERY_TYPE | VARCHAR2(16 CHAR) | Indicates the query type. |
\n STATE | VARCHAR2(255 CHAR) | Indicates a query's status: OpenedAnsweredClosedCandidate query
|
\n QUERYAGE | NUMBER | Indicates the number of days passed since a query was first opened. - Current (Active) Record: Indicates how many days have passed since the query was first opened until today while it remains open. This means query age should be
0 when the query gets an opened status and increment the longer it remains open. - For candidate and deleted queries, query age should be always
0. - For candidate queries created on one date and opened on a different date, query age should be
0 at the time it gets an opened status and increment the longer it remains open. - For answered queries, reopened queries, and reopened queries with subsequent answers, as long as the status is still opened, query age should indicate how many days have passed since it was first opened until the current system's date.
- Closed Record: Indicates how long the query was open, from the first opened date to the date it was closed.
- Audit (Version-Ended) Record: Indicates the duration that each version of a query was active, measured from when it was opened to when that particular version ended.
|
\n QUERY_COMMENT | VARCHAR2(2048 CHAR) | Indicates a comment associated with a query, as entered by the user who last modified the query. |
\n ASSIGNED_ROLES | VARCHAR2(32767 CHAR) | Indicates the roles that are assigned to receive a query. |
\n IS_AUTO_QUERY | VARCHAR2(1 CHAR) | Indicates whether this is an automated query. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit trail metadata that explains when the row version became effective, who changed it, and whether it is current.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(20 CHAR) | Comment for record change. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(32 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(32 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(32 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(32 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(32 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n QUERY_ID | RAW(32 BYTE) | GUID of the query. |
\n QUERY_WID | NUMBER(10) | A number that represents the unique identifier of the query. |
\n USER_ID | RAW(32 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent record. |
\n PARENT_WID | NUMBER | Indicates the numeric identifier of the parent record. A sentinel value of -1 can appear when no parent record applies. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root record. |
\n ROOT_WID | NUMBER | Indicates the numeric identifier of the root record. A sentinel value of -1 can appear when no root record applies. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Indicates the number of times the form has been repeated. |
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the number of times the event has been repeated for the subject. |
\n TRANSACTION_START | DATE | Indicates the transaction start date associated with the queried subject form item record. |
\n TRANSACTION_END | DATE | Indicates the transaction end date associated with the queried subject form item record. |
\n STATE_ID | NUMBER | A number that represents the unique identifier of the query state. |
\n RULE_ID | RAW(32 BYTE) | GUID of the rule. |
\n DISCREPANCY_ID | NUMBER(38) | Indicates the discrepancy identifier associated with the query. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | GUID of the subject form item record associated with the queried data element. |
\n VARIABLE_ID | RAW(16 BYTE) | GUID of the variable. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Indicates the date and time when the referenced property version became effective. |
\n DATA_ELEMENT_VERSION_START | TIMESTAMP(6) | Timestamp of a given item's start date. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of the normalized unit. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally as the underlying query dataset row is versioned. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"QueryDataSetReport":{
"description":"QueryDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"PROPERTY_NAME",
"PROPERTY_TYPE",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"DATA_ELEMENT_VERSION_START"
],
"data":[
[
"3A06FA4026504D819D33D6061B0AF6AB",
"1",
"0",
"Candidate",
"please provide more details ",
"CE5F2D7A9B4C4D1E8F2A6C3B7D8E9A10",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"4F9D07D644904CEAB2F2DEFA02E8921C",
"2",
"DATAHUB_AUT_Site2_Active02",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"0",
"0",
"CF149710CBE24A6BB9266E52B5F5BA0F",
"618",
"Subject Initials",
"2025-10-30T17:02:09.726Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"2",
"Auto query created",
"Auto-created",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-30T17:04:02.544Z",
"1001",
"N",
"Y",
"Range Check",
"Edit Check",
"Site CRA;Data Manager",
"0",
"6529F9EBEB914CED8DAED37B7C3DBCFA",
"41",
"FORM_02",
"6",
"2025-10-30T17:00:00.000Z",
"2025-10-30T17:02:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"ABC",
null,
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"2025-10-30T17:02:09.000Z",
"10",
"30",
"2025",
"17",
"02",
"09",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"ScreeningForm",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"ScreeningForm",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"ABC",
"ABC",
"TEXT",
"TEXT",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"FBDBB9C9A70C470E8E90B812460F00F8",
"2025-12-11T21:45:21.430Z",
"Enter subject initials",
"1",
"0",
"Subject_Initials",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"New",
"DATAHUB_AUT_Site2_Screen02",
"DATAHUB_AUT_Site2_Active02",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"COMPLETED",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"ScreeningForm",
"SCREENINGFORM",
"INPROGRESS",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"N",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"candidate",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"27",
"N",
"N"
]
]
}
},
"QueryDataSetEmptyReport":{
"description":"QueryDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"PROPERTY_NAME",
"PROPERTY_TYPE",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"DATA_ELEMENT_VERSION_START"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-{mode}-queries-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-mode-queries-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: EHR_ENABLED, EHR_LINK_STATUS, WITHDRAWAL_DATE, and STUDY_COMPLETION_DATE.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectDataset",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STUDY_COMPLETION_DATE | DATE | Date in which the subject completed the study. |
\n WITHDRAWAL_DATE | DATE | Date in which the subject got withdrawn from the study. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n EXTERNAL_SOURCE_STATUS_DATE | TIMESTAMP(6) | Indicates the date on which the subject status was updated by an external source. |
\n EHR_LINK_STATUS | CHAR(1) | Displays Yes or No, indicating if a subject is currently linked for Electronic Health Record (EHR) data import. Possible values include Y or N. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if the subject's data is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the aggregate verification status for the subject's data. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the subject. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Screen01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"N",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"Initial subject creation",
"Created via data hub load",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"DATAHUB_AUT_Site2_Active01",
"N",
"N",
"N",
"2025-10-29T13:00:00.000Z",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"N",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: HAS_QUERY, CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | Indicates if the item has an associated query. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Indicates the question type as specified by the study designer. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | A number that represents the unique identifier of the item. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | Indicates the current status of the subject in the study. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Indicates the row position of the item. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"DATAHUB_AUT_Site2_Screen07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"0",
"0",
"0",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"N",
"N",
"Manual Entry"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_REFNAME.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
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"limit":1,
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"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
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"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: CURRENT_STUDY_ROLE_ID, CURRENT_STUDY_ROLE_WID, and CURRENT_STUDY_ROLE_NAME.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n UNBLIND_DATE | TIMESTAMP(6) | Indicates the date and time when the first code break was performed and the subject's treatment arm was unblinded. This value is a timestamp. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date. |
\n UNBLIND_REASON | VARCHAR2(255 CHAR) | Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason. |
\n UNBLIND_COMMENT | VARCHAR2(2048 CHAR) | Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier that represents the treatment arm. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
[
"7550C1E7E3CA4B8CAD09ACD1F1E7F580",
"37",
"0C7CBA3F70034C47947E2FAB086BFBF5",
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"13",
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"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
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"1",
"Y",
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"ScreeningForm",
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"0",
"0",
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"0",
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"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
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"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
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"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"KIT-000457",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1.0.0.3",
"false",
"Dr.",
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"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
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"test@abc.com",
"456abc",
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"Boston",
"US",
"Kansas",
"560068",
"1234567891",
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"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N",
"0",
"Treatment Arm A",
"Arm A dosing schedule",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_REFNAME.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedSubjectDataSetQuery_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Screen01",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v7.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: SCREENING_NUMBER, COUNT_OF_KITS, and IS_NON_SERIALIZED_KIT.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n ITEM_NUMBER | VARCHAR2(64 CHAR) | Numeric value used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n MATERIAL_ID | VARCHAR2(64 CHAR) | Alphanumeric identifier of the material of a given kit, used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(1020) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n IS_NON_SERIALIZED_KIT | CHAR(1) | Indicates if the kit is non serialized: Y (Yes) the kit is non-serialized. N (No) the kit is serialized. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER | Numeric identifier of the confirming user. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
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"Study01",
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"Default Cohort",
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"2026-12-31T00:00:00.000Z",
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"2025-10-28T10:00:00.000Z",
"TRK123999",
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"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
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"255",
"50254",
"mHC2CDevice",
"Dispensed",
"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
"N/A",
"Once Daily",
"0",
"0",
"false",
"1",
"1",
"7E6D5C4B3A29100FEE12DDCCBBAA9988",
"0",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"0",
"70",
"2025-10-29T17:31:19.861Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"4",
"Data correction",
"Updated during data sync",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"Y",
"11223344556677889900AABBCCDDEEFF",
"88",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"A1B2C3D4E5F60718293A4B5C6D7E8F90",
"88",
"Site Pharmacist",
"2025-10-29T12:20:00.000Z",
"2",
"2025-10-29T17:32:35.284Z",
"BLK-0001",
"50262",
"MAT-001",
"ITEM-001",
"1",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)"
]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v7.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v7.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"V8.0",
"description":"Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: REASON_FOR_REVISION, VERSION_TITLE, IS_APPROVED, EARLIEST_VISIT_TO_COMPLETE, VISIT_ORDER, FORM_ORDER, ITEM_ORDER, ITEM_GROUP_ORDER, DATA_CLASSIFICATION, DATA_TYPE, and APPLY_CHANGE_VERSION.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_26",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"IS_APPROVED",
"REASON_FOR_REVISION",
"VERSION_TITLE",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"VISIT_ORDER",
"EARLIEST_VISIT_TO_COMPLETE",
"FORM_ORDER",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_ORDER",
"ITEM_GROUP_ORDER",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"DATA_CLASSIFICATION",
"DATA_TYPE",
"APPLY_CHANGE_VERSION",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n VERSION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the study version. If a value has not been specified for this element, its value displays as NULL. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n IS_APPROVED | CHAR(1) | This element aides in reviewing Archived study versions that may have been in the Active container in the past. It is applicable to all study versions, and is labeled as: N for any Study Version that was never moved to Active mode.Y for study versions moved from Test to Active. Also applicable when those versions are subsequently moved to archive.
|
\n REASON_FOR_REVISION | VARCHAR2(32 CHAR) | Indicates the user provided reason for revising the study version. This reason is provided when moving a study version from Test to Active container. If a value has not been specified for this element, its value displays as NULL. Possible values include INITIAL, PROTOCOL_AMENDMENT, REVISION, or VERSION. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n REQ_SCREENING | CHAR(1) | Indicates if the question is required for screening. Possible values include Y or N. |
\n REQ_RANDOMIZE | CHAR(1) | Indicates if the question is required for randomization. Possible values include Y or N. |
\n REQ_DISPENSE | CHAR(1) | Indicates if the question is required for dispensation. Possible values include Y or N. |
\n OCC_ENABLED | CHAR(1) | Indicates if a study is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a study or if a study was disabled for EHR. Possible values include Y or N.
|
\n SAFETY_INTEGRATION_ENABLED | CHAR(1) | Indicates if the Clinical One Cloud Service to Safety integration is enabled for the study. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_ORDER | NUMBER | An integer indicating a visit's ordinal position (order) within the visit schedule for the selected study version. These values may change across versions; for example, a visit that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new visit is inserted at position 3. Note: Ordinal values are study design attributes only and do not reflect a subject's progress through a study or carry clinical significance. About draft study versions: VISIT_ORDER values won't appear in the dataset for a draft study version until you either move the draft to the test container or choose Send to Analytics from the draft container menu. About visits: The dataset output displays scheduled (non-branch and branch) visits and unscheduled visits in the following manner. - Scheduled non-branch visits (for example, a screening visit) are listed first, followed by scheduled branch visits, and finally unscheduled visits when the
VISIT_ORDER is sorted in ascending order. - Scheduled branch visits are assigned an ordinal value that reflects their position in a branch. When sorted in ascending order, visits from earlier tiers appear before those in later ones.
Note: A tier, the highest level in visit branch design, is used to organize parallel branches, also called arms or cohorts. Each branch consists of a group of visits. For instance, a study includes two tiers (Tier1 and Tier2); each consists of two branches (BranchA and BranchB), and each branch contains a set of visits (Day1 and Day15). When sorted in ascending order, they appear as follows in the output. - Tier1.BranchA.Day1
- Tier1.BranchA.Day15
- Tier1.BranchB.Day1
- Tier1.BranchB.Day15
- Tier2.BranchA.Day1
- Tier2.BranchA.Day15
- Tier2.BranchB.Day1
- Tier2.BranchB.Day15
- Unscheduled visits, which include Withdrawal, Screen Fail, Rescreen, and Study Completion visits, are assigned an ordinal value based on the sequence defined on the Unscheduled Visit or Event sidebar and appear after scheduled branch visits when
VISIT_ORDER is sorted in ascending order.
|
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n EARLIEST_VISIT_TO_COMPLETE | VARCHAR2(64 CHAR) | When creating a study completion visit, you can specify an earlier visit that must be completed in order to enable the option for marking the subject as Complete. The reference name of that specified scheduled visit is provided in this field. This data element is added for each event. However, it is only specified when the record is for a Subject Completion event, while all other records display as a NULL value. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n ALERT_OUTSIDE_VISIT_WINDOW | VARCHAR2(16 CHAR) | Indicates if there is any rule set to alert if visit date is out of window. Values can be: |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_ORDER | NUMBER | An integer indicating a form's ordinal position (order) within a visit for the selected study version. These values may change across versions; for example, a form that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new form is inserted at position 3. Note: Ordinal values are positive integers that indicate the sequence of forms in a visit as defined by the study design. They do not indicate if a form was started or completed and do not carry any clinical significance. About Advanced Study Versioning (ASV): Duplicate FORM_ORDER values appear in the output when a new form is added using Advanced Study Versioning (ASV) and the dataset is generated for a previous study version. For example, study version 1.0.0.1 includes three forms, and study version 1.0.0.2 introduces a new form (Vitals). The output appears as follows when the dataset is generated for version 1.0.0.1. However, if the dataset is generated for version 1.0.0.2, no duplicate values appear and the order is sequentially correct. |
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_MULTIPLE_INSTANCES | NUMBER | Indicates whether multiple instances of the same form can be added within a visit. Possible values include 0 or 1. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n DATA_TYPE | VARCHAR2(64 CHAR) | Indicates the data format of the collected data. Note: Data type refers to how collected data is stored, which is different from the question type that defines how the question is presented to the site user. Possible values include VARCHAR, NUMBER, or DATE. |
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n ITEM_GROUP_ORDER | NUMBER | Indicates the order of items on two-section forms and in question group type questions. For example, a study's design includes a question group labeled Scan 1 with two questions: Scan Date and Upload Scan. In the design the group is treated as a single question, so in the output, the ITEM_GROUP and ITEM_ORDER are the same for each question in the group, and ITEM_GROUP_ORDER reflects each question's position within the group. For any other form or question types, ITEM_GROUP_ORDER is NULL. |
\n ITEM_ORDER | NUMBER | A numeric value indicating the ordinal position (order) of a question on a form for the selected study version. - Version-specific:
ITEM_ORDER reflects the order as defined in that specific study version. Values may change across study versions. For example, a question that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new question is inserted at position 3. - Not always an integer: In some study versions,
ITEM_ORDER may appear as a decimal value (for example, 2.001 or 4.001). This can occur when new items are inserted into an existing form in a particular study version (for example, items inserted after an existing question and associated with ASV). In these cases, the decimal value indicates the position of the inserted item relative to the prior item without renumbering all subsequent items in that version. - Latest version may be re-sequenced: When viewing a later or the latest study version, the same form may show a fully re-sequenced order using consecutive integers (for example,
1, 2, 3, 4, 5, 6).
In a later/latest study version, the order may be displayed as consecutive integers (for example): 1, 2, 3, 4, 5, 6 Note: Ordinal values indicate the sequence of questions on forms as defined by the study design for the selected study version. They do not indicate whether a question was answered and do not carry any clinical significance. About Age items on forms: When an Age item is added to a form, the system also adds a Date of Birth field and displays them together, making it appear as a single question in the study design. In the study design dataset, however, Age (a calculated item) and Date of Birth are recorded as two distinct items, each on its own row with a unique ordinal value. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767 CHAR) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ALLOW_FUTURE_DATE | NUMBER(1) | For Date/Time questions. Indicates if the user is allowed to enter a future date. Possible values include 0 or 1. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n DATA_CLASSIFICATION | VARCHAR2(2048 CHAR) | Indicates how the data is categorized according to its sensitivity and intended use. Applicable only to hidden items. This data element populates with a comma separated list of all the selected data classification groups of a hidden item. Possible values for this element include: Adjudication dataBlinded dataPII dataPublic dataSponsor data
|
\n EHR_MAPPING | VARCHAR2(32767 CHAR) | Displays the OCC data dictionary mapping value for a question mapped for Electronic Health Record (EHR) data import. |
\n VALIDATION_RULES | VARCHAR2(32767 CHAR) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n APPLY_CHANGE_VERSION | VARCHAR2(32 CHAR) | Indicates the version in which changes to the form item apply. This data element refers to the lowest study version in which the change is applied. This means the change is included in all study versions between the APPLY_CHANGE_VERSION and the current study version. |
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | RAW(16 BYTE) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
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"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_ORDER",
"ITEM_GROUP_ORDER",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"DATA_CLASSIFICATION",
"DATA_TYPE",
"APPLY_CHANGE_VERSION",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v8.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds new clinical one extension attribute 'SDVSelectionStatus' based on is the data captured in the item is targeted (Obligatory) not targeted (Optional) or not configured for SDV (Irrelevant) at the item level transactions. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"active",
"training"
]
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v8.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v8.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds new clinical one extension attribute 'SDVSelectionStatus' based on is the data captured in the item is targeted (Obligatory) not targeted (Optional) or not configured for SDV (Irrelevant) at the item level transactions. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"active",
"training"
]
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v8.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v8.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract meta data in the CDISC ODM-XML format. This version introduces a new clinical one extension attributes 'MandatoryScreening' if an item is required for Screening, 'MandatoryRandomize' if an item is required for Randomization, 'MandatoryDispense' if an item is required for Dispensation and 'SafetyIntegrationEnabled' if study is enabled for Safety Integration.",
"operationId":"getMetadata_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"active",
"training"
]
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string",
"format":"date-time"
},
"example":"2024-01-01T00:00:00Z"
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
},
"example":"1.0.0.1"
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV1"
},
"examples":{
"StudyMetadataResponse":{
"description":"StudyMetadataResponse",
"value":"STUDY01STUDY01STUDY01mgYearsmmHgcmKilogramkgKgEnableDynamicVisit?Association"
}
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"ErrorResponseExample":{
"description":"ErrorResponseExample",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"INVALID_START_TIME",
"errorMessage":"Invalid fromTimestamp in the request url"
},
"version":1
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v8.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/{mode}/queries":{
"post":{
"tags":[
"Data Hub/Datasets/Get queries raised for study"
],
"summary":"V8.0",
"description":"Retrieves the study-permissioned Queries dataset for a single study and mode.
The dataset exposes query lifecycle history raised against clinical data, including query state and comments, rule context, study, site, subject, visit, form, and item context, together with audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns query-history rows for the selected study and mode, not only currently open queries.
This version additionally includes the following data points: EHR_IMPORTED and EHR_ENABLED.
Required permission: StudyQueryDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and QUERY_ID in the orderColumns field of the request payload.
",
"operationId":"getStudyQueryDataset",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"QueryDataSetQuery":{
"description":"QueryDataSetQuery",
"value":{
"selectColumns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"PROPERTY_NAME",
"PROPERTY_TYPE",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"DATA_ELEMENT_VERSION_START",
"EHR_IMPORTED",
"EHR_ENABLED"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"QUERY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Subject context | Event context | Form context | Item context | Query context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. Possible values include 1.3.0.8 or 5.3.0.16. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. Possible values include America/New_York or Asia/Kolkata. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit scheduling, status, and execution attributes associated with the queried record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.NOT_STARTED: the visit has not been started.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. Possible values include 0, 1, or 7. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design, repeat, and status attributes associated with the queried data element.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only receive this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nItem-level values, validation output, derived representations, and item metadata associated with the query.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. Possible values include TEXT, DATETIME, NUMERIC, CHOICE, LABEL, or FILE_UPLOAD. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
Possible values include Text, DateTime, Number, Measurement, Calculation, Choice, label, or FileUpload. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Populated and used by Oracle Clinical One Platform integrations. |
\n FORMITEM_IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n READONLY | NUMBER | Indicates that the question is marked as read-only by a study designer. Possible values include 0 or 1. |
\n HIDDEN | NUMBER | Indicates if a question is hidden, as marked by a study designer. Possible values include 0 or 1. |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VALUE | VARCHAR2(16000) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(16000) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(16000) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(16000) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n\n
\n\nParent topic: Section index
\n
\n\nQuery context
\nQuery lifecycle fields that describe the discrepancy, its state, ownership, and query-specific classification.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n PROPERTY_NAME | VARCHAR2(256 CHAR) | Name of the property to which the query is associated to. Note: This only applies to queries on visit dates and the default is visitStartDate. For other queries, this value is null. |
\n PROPERTY_TYPE | VARCHAR2(256 CHAR) | Type of property to which the query is associated to. Note: This only applies to queries on visit dates and the default is visit. For other queries, this value is null. |
\n QUERY_TYPE | VARCHAR2(16 CHAR) | Indicates the query type. |
\n STATE | VARCHAR2(255 CHAR) | Indicates a query's status: OpenedAnsweredClosedCandidate query
|
\n QUERYAGE | NUMBER | Indicates the number of days passed since a query was first opened. - Current (Active) Record: Indicates how many days have passed since the query was first opened until today while it remains open. This means query age should be
0 when the query gets an opened status and increment the longer it remains open. - For candidate and deleted queries, query age should be always
0. - For candidate queries created on one date and opened on a different date, query age should be
0 at the time it gets an opened status and increment the longer it remains open. - For answered queries, reopened queries, and reopened queries with subsequent answers, as long as the status is still opened, query age should indicate how many days have passed since it was first opened until the current system's date.
- Closed Record: Indicates how long the query was open, from the first opened date to the date it was closed.
- Audit (Version-Ended) Record: Indicates the duration that each version of a query was active, measured from when it was opened to when that particular version ended.
|
\n QUERY_COMMENT | VARCHAR2(2048 CHAR) | Indicates a comment associated with a query, as entered by the user who last modified the query. |
\n ASSIGNED_ROLES | VARCHAR2(32767 CHAR) | Indicates the roles that are assigned to receive a query. |
\n IS_AUTO_QUERY | VARCHAR2(1 CHAR) | Indicates whether this is an automated query. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit trail metadata that explains when the row version became effective, who changed it, and whether it is current.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n EHR_IMPORTED | CHAR(1) | Indicates if a question was populated via an Electronic Health Record (EHR) data import. If EHR data import is disabled after the data is imported, EHR_IMPORTED continues to show Yes. Possible values include Y or N. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(20 CHAR) | Comment for record change. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(32 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(32 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(32 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(32 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(32 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n QUERY_ID | RAW(32 BYTE) | GUID of the query. |
\n QUERY_WID | NUMBER(10) | A number that represents the unique identifier of the query. |
\n USER_ID | RAW(32 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n PARENT_ID | RAW(16 BYTE) | GUID of the parent record. |
\n PARENT_WID | NUMBER | Indicates the numeric identifier of the parent record. A sentinel value of -1 can appear when no parent record applies. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root record. |
\n ROOT_WID | NUMBER | Indicates the numeric identifier of the root record. A sentinel value of -1 can appear when no root record applies. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Indicates the number of times the form has been repeated. |
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the number of times the event has been repeated for the subject. |
\n TRANSACTION_START | DATE | Indicates the transaction start date associated with the queried subject form item record. |
\n TRANSACTION_END | DATE | Indicates the transaction end date associated with the queried subject form item record. |
\n STATE_ID | NUMBER | A number that represents the unique identifier of the query state. |
\n RULE_ID | RAW(32 BYTE) | GUID of the rule. |
\n DISCREPANCY_ID | NUMBER(38) | Indicates the discrepancy identifier associated with the query. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | GUID of the subject form item record associated with the queried data element. |
\n VARIABLE_ID | RAW(16 BYTE) | GUID of the variable. |
\n ORIGINATOR_ID | RAW(16 BYTE) | GUID of the originator. |
\n PROPERTY_ID | RAW(16 BYTE) | GUID of the property. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Indicates the date and time when the referenced property version became effective. |
\n DATA_ELEMENT_VERSION_START | TIMESTAMP(6) | Timestamp of a given item's start date. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n SUBJECT_EVENT_INST_WID | NUMBER(10) | A number that represents the unique identifier of the subject event instance. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Reserved for future use. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | GUID of the normalized unit. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally as the underlying query dataset row is versioned. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"QueryDataSetReport":{
"description":"QueryDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"PROPERTY_NAME",
"PROPERTY_TYPE",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"DATA_ELEMENT_VERSION_START",
"EHR_IMPORTED",
"EHR_ENABLED"
],
"data":[
[
"3A06FA4026504D819D33D6061B0AF6AB",
"1",
"0",
"Candidate",
"please provide more details ",
"CE5F2D7A9B4C4D1E8F2A6C3B7D8E9A10",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"4F9D07D644904CEAB2F2DEFA02E8921C",
"2",
"DATAHUB_AUT_Site2_Active02",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"0",
"0",
"CF149710CBE24A6BB9266E52B5F5BA0F",
"618",
"Subject Initials",
"2025-10-30T17:02:09.726Z",
"3099-12-31T00:00:00.000Z",
"CREATED",
"1",
"2",
"Auto query created",
"Auto-created",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-30T17:04:02.544Z",
"1001",
"N",
"Y",
"Range Check",
"Edit Check",
"Site CRA;Data Manager",
"0",
"6529F9EBEB914CED8DAED37B7C3DBCFA",
"41",
"FORM_02",
"6",
"2025-10-30T17:00:00.000Z",
"2025-10-30T17:02:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"ABC",
null,
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"2025-10-30T17:02:09.000Z",
"10",
"30",
"2025",
"17",
"02",
"09",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"ScreeningForm",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"ScreeningForm",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"ABC",
"ABC",
"TEXT",
"TEXT",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"FBDBB9C9A70C470E8E90B812460F00F8",
"2025-12-11T21:45:21.430Z",
"Enter subject initials",
"1",
"0",
"Subject_Initials",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"New",
"DATAHUB_AUT_Site2_Screen02",
"DATAHUB_AUT_Site2_Active02",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"COMPLETED",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"ScreeningForm",
"SCREENINGFORM",
"INPROGRESS",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Started",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"N",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"candidate",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"27",
"N",
"N",
"N",
"N "
]
]
}
},
"QueryDataSetEmptyReport":{
"description":"QueryDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"QUERY_ID",
"QUERY_WID",
"STATE_ID",
"STATE",
"QUERY_COMMENT",
"RULE_ID",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"DISCREPANCY_ID",
"HAS_QUERY",
"IS_CURRENT",
"PROPERTY_NAME",
"PROPERTY_TYPE",
"ASSIGNED_ROLES",
"QUERYAGE",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"FORM_REFNAME",
"SUBJECT_EVENT_INST_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"FORM_SECTION_ID",
"FORM_STATUS",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"IS_AUTO_QUERY",
"QUERY_TYPE",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"DATA_ELEMENT_VERSION_START",
"EHR_IMPORTED",
"EHR_ENABLED"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-{mode}-queries-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-mode-queries-post"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"V8.0",
"description":"Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: WITHDRAWAL_REASON, WITHDRAWAL_COMMENT, SCREEN_FAILURE_DATE, SCREEN_FAILURE_COMMENT, and RESCREEN_INSTANCE_NUM.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectDataset_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE",
"WITHDRAWAL_REASON",
"WITHDRAWAL_COMMENT",
"REASON",
"COMMENT",
"SCREEN_FAILURE_DATE",
"SCREEN_FAILURE_COMMENT",
"SCREENING_FAILURE",
"RESCREEN_INSTANCE_NUM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n RESCREEN_INSTANCE_NUM | NUMBER | Instance number of the re-screening event for the subject. If this is the second time a subject is re-screened, the instance number would be 2. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STUDY_COMPLETION_DATE | DATE | Date in which the subject completed the study. |
\n WITHDRAWAL_DATE | DATE | Date in which the subject got withdrawn from the study. |
\n SCREEN_FAILURE_DATE | DATE | Date in which the subject failed screening. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREEN_FAILURE_COMMENT | VARCHAR2(2048 CHAR) | Comment added by the site user for a subject's screen failure event. |
\n WITHDRAWAL_REASON | VARCHAR2(255 CHAR) | Reason provided for a subject's withdrawal from study. |
\n WITHDRAWAL_COMMENT | VARCHAR2(2048 CHAR) | Comment added by the site user for the subject's withdrawal event. |
\n EXTERNAL_SOURCE_STATUS_DATE | TIMESTAMP(6) | Indicates the date on which the subject status was updated by an external source. |
\n EHR_LINK_STATUS | CHAR(1) | Displays Yes or No, indicating if a subject is currently linked for Electronic Health Record (EHR) data import. Possible values include Y or N. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if the subject's data is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the aggregate verification status for the subject's data. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the subject. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE",
"WITHDRAWAL_REASON",
"WITHDRAWAL_COMMENT",
"REASON",
"COMMENT",
"SCREEN_FAILURE_DATE",
"SCREEN_FAILURE_COMMENT",
"SCREENING_FAILURE",
"RESCREEN_INSTANCE_NUM"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Screen01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"DATAHUB_AUT_Site2_Active01",
"N",
"N",
"N",
"2025-10-29T13:00:00.000Z",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"N",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"Initial subject creation",
"Created via data hub load",
"3099-12-31T00:00:00.000Z",
"",
"N",
"0"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE",
"WITHDRAWAL_REASON",
"WITHDRAWAL_COMMENT",
"REASON",
"COMMENT",
"SCREEN_FAILURE_DATE",
"SCREEN_FAILURE_COMMENT",
"SCREENING_FAILURE",
"RESCREEN_INSTANCE_NUM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_REFNAME.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | Indicates if the item has an associated query. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Indicates the question type as specified by the study designer. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | A number that represents the unique identifier of the item. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | Indicates the current status of the subject in the study. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Indicates the row position of the item. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormItemsDataSetReport":{
"description":"SubjectFormItemsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"DATAHUB_AUT_Site2_Screen07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"9F7B4E2D1C0A4781B2C3D4E5F6071829",
"0",
"0",
"0",
"0",
"339F9E014F5140048D66DA85143CDF2C",
"176",
"2025-10-29T14:59:00.000Z",
"2025-10-29T15:00:00.000Z",
"SUCCESS",
"None",
"7C2FA1D0E3B44803B6C5A4F29E8D7C61",
"1A2B3C4D5E6F708192A3B4C5D6E7F809",
"ABC",
"ABC",
"Kilogram",
"8E6F5D4C3B2A1900FEEDCBA987654321",
"5C6D7E8F4091A2B3C4D5E6F708193A4B",
"0",
"1.5555",
"10",
"29",
"2025",
"15",
"0",
"0",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"3A4B5C6D7E8F4091A2B3C4D5E6F70819",
"45",
"-1",
"4B5C6D7E8F4091A2B3C4D5E6F708193A",
"46",
"5F6E7D8C9B0A4E31A2B3C4D5E6F71829",
"DE9626CE70F77849E053D79B4C6409C0",
"ABC",
"TEXT",
"TEXT",
"2F1E3D4C5B6A79808796A5B4C3D2E1F9",
"447DF571D4ED49DFA779A04941C4B191",
"2026-01-25T20:02:00.614Z",
"Enter subject initials",
"1",
"0",
"0",
"Subject Initials",
"N",
"N",
"SUBJECT_INITIALS",
"0",
"0",
"1305395A4A9E48239BFBD00542E1664B",
"23",
"2025-10-29T15:03:37.389Z",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"33D0D74837F6454B836AAB5BA2574D30",
"0000000000000000000000000000000A",
"32",
"1",
"8",
"8",
"Captured during screening",
"Y",
"2025-10-29T15:11:33.098Z",
"2026-04-29T11:37:07.588Z",
"14",
"EE39008E187C4F10817CEF4C27EB1BCA",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"D63FC00C7C5A4A1CA1A65B5638AEFA9D",
"10",
"SCREENINGFORM",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"2025-10-29T00:00:00.000Z",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-09-24T00:00:00.000Z",
"2025-09-29T00:00:00.000Z",
"2025-09-26T00:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"137",
"0",
"66",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"1234567891",
"343",
"560068",
"test@abc.com",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"N",
"N",
"SIGNED",
"N",
"1.0.0.3",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"Tester2",
"N",
"LAB01",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"7E8E9AD3EB4544CA91B6BC9E20777FBD",
"N",
"N",
"Manual Entry"
]
]
}
},
"SubjectFormItemsDataSetEmptyReport":{
"description":"SubjectFormItemsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: SCREENING_NUMBER.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_12",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: SCHEDULED_FROM_EVENT_REFNAME.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n UNBLIND_DATE | TIMESTAMP(6) | Indicates the date and time when the first code break was performed and the subject's treatment arm was unblinded. This value is a timestamp. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date. |
\n UNBLIND_REASON | VARCHAR2(255 CHAR) | Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason. |
\n UNBLIND_COMMENT | VARCHAR2(2048 CHAR) | Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier that represents the treatment arm. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
[
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"ScreeningForm",
"SCREENINGFORM",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
"10007890",
"2025-10-29T17:00:00.000Z",
"1",
"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"KIT-000457",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N",
"0",
"Treatment Arm A",
"Arm A dosing schedule",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: SCREENING_NUMBER.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"retrieveBlindedSubjectDataSetQuery_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Screen01",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v8.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: ORDER_TYPE and FORCED_RAND.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n FORCED_RAND | CHAR(1) | Indicates whether the subject underwent forced randomization. This helps track how many times forced randomization has been used over the course of the study. This scenario can occur due to a lack of kits for at least one treatment arm in the study at the time of randomization. For this data element, the following values can be displayed: Y: Indicates that a subject underwent forced randomization.N: Indicates that a subject was randomized normally.NULL: Indicates that a subject has not yet been randomized.
|
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n ORDER_TYPE | VARCHAR2(50 CHAR) | Indicates how a shipment was initiated: INITIAL; MANUAL; RESUPPLY |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n ITEM_NUMBER | VARCHAR2(64 CHAR) | Numeric value used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n MATERIAL_ID | VARCHAR2(64 CHAR) | Alphanumeric identifier of the material of a given kit, used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(1020) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n IS_NON_SERIALIZED_KIT | CHAR(1) | Indicates if the kit is non serialized: Y (Yes) the kit is non-serialized. N (No) the kit is serialized. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER | Numeric identifier of the confirming user. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"Site",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"Complete",
"DATAHUB_AUT_Site2_Active13",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"19",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"0",
"0",
"1",
"Assigned",
"2025-10-29T17:31:09.030Z",
"MLOT1",
"BLT1",
"MLOT1",
"BLT1",
"2030-12-31T00:00:00.000Z",
"2026-12-31T00:00:00.000Z",
"10",
"0",
"10",
"0",
"9A8B7C6D5E4F4A1B8C7D6E5F4A3B2C1D",
"1001",
"SHIP-0002",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"TRK123999",
"1",
"Y",
"Week2",
"WEEK2",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"DISPENSATION",
"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
"28",
"0",
"2",
"0",
"2",
"0",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"Week3",
"WEEK3",
"Week3",
"1536",
"Device",
"ActivityWatch",
"DevicetoCloud",
"0",
"UNBLINDED",
"D26E345F8CBD44B6A22C666F11D1F04D",
"27",
"Device",
"DEVICE",
"1",
"1",
"0",
"N/A",
"0",
"0",
"0",
"424CA68C1E523E82E063BDD14C646211",
"255",
"50254",
"mHC2CDevice",
"Dispensed",
"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
"N/A",
"Once Daily",
"0",
"0",
"false",
"1",
"1",
"7E6D5C4B3A29100FEE12DDCCBBAA9988",
"0",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"0",
"70",
"2025-10-29T17:31:19.861Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"4",
"Data correction",
"Updated during data sync",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"Y",
"11223344556677889900AABBCCDDEEFF",
"88",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"A1B2C3D4E5F60718293A4B5C6D7E8F90",
"88",
"Site Pharmacist",
"2025-10-29T12:20:00.000Z",
"2",
"2025-10-29T17:32:35.284Z",
"BLK-0001",
"50262",
"MAT-001",
"ITEM-001",
"1",
"N",
"Outbound",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)"
]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v8.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v8.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/dataCollection":{
"post":{
"tags":[
"Data Hub/Datasets/Get study design dataset"
],
"summary":"V9.0",
"description":"Retrieves the study-permissioned Study Design dataset for a single study and mode.
The dataset exposes versioned study design configuration, including branches, visits, scheduled-from relationships, forms, item groups, items, value and codelist settings, display and validation properties, and design audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows for design elements at branch, event, form, and item granularity for the study versions available in the selected mode.
This version additionally includes the following data points: SDV_VISIT_START, CODELIST_LINK_TYPE, and CODELIST_LANG.
Required permission: DataCollectionDesignDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, STUDY_VERSION, BRANCH_ID, EVENT_ID, FORM_ID, ITEM_ID, and SCHEDULED_FROM_EVENT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveQueryDataSet_27",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"DataCollectionDataSetQuery":{
"description":"DataCollectionDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"IS_APPROVED",
"REASON_FOR_REVISION",
"VERSION_TITLE",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"VISIT_ORDER",
"EARLIEST_VISIT_TO_COMPLETE",
"FORM_ORDER",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_ORDER",
"ITEM_GROUP_ORDER",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"DATA_CLASSIFICATION",
"DATA_TYPE",
"APPLY_CHANGE_VERSION",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED",
"SDV_VISIT_START",
"CODELIST_LINK_TYPE",
"CODELIST_LANG"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"STUDY_VERSION",
"sortOrder":"ASC"
},
{
"columnName":"BRANCH_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
},
{
"columnName":"SCHEDULED_FROM_EVENT_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Branch context | Event context | Form context | Item context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n VERSION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the study version. If a value has not been specified for this element, its value displays as NULL. |
\n STUDY_DESIGN_STATUS | VARCHAR2(16 CHAR) | Indicates the study design version status associated with the dataset row. Possible values include DRAFT, TESTING, APPROVED, ARCHIVED, or OLDDRAFT. |
\n IS_APPROVED | CHAR(1) | This element aides in reviewing Archived study versions that may have been in the Active container in the past. It is applicable to all study versions, and is labeled as: N for any Study Version that was never moved to Active mode.Y for study versions moved from Test to Active. Also applicable when those versions are subsequently moved to archive.
|
\n REASON_FOR_REVISION | VARCHAR2(32 CHAR) | Indicates the user provided reason for revising the study version. This reason is provided when moving a study version from Test to Active container. If a value has not been specified for this element, its value displays as NULL. Possible values include INITIAL, PROTOCOL_AMENDMENT, REVISION, or VERSION. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n REQ_SCREENING | CHAR(1) | Indicates if the question is required for screening. Possible values include Y or N. |
\n REQ_RANDOMIZE | CHAR(1) | Indicates if the question is required for randomization. Possible values include Y or N. |
\n REQ_DISPENSE | CHAR(1) | Indicates if the question is required for dispensation. Possible values include Y or N. |
\n OCC_ENABLED | CHAR(1) | Indicates if a study is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a study or if a study was disabled for EHR. Possible values include Y or N.
|
\n SAFETY_INTEGRATION_ENABLED | CHAR(1) | Indicates if the Clinical One Cloud Service to Safety integration is enabled for the study. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nBranch context
\nBranching and assignment rules that determine subject flow through the study design.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BRANCH_TITLE | VARCHAR2(64 CHAR) | Indicates the branch title or name. |
\n BRANCH_REFNAME | VARCHAR2(64 CHAR) | Indicates the branch reference name used by the system. |
\n BRANCH_VISIT | VARCHAR2(64 CHAR) | Specifies the visit containing the selected form and question that is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_FORM | VARCHAR2(64 CHAR) | Specifies which form contains the question used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_QUESTION | VARCHAR2(4000 CHAR) | Specifies which question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ANSWER | VARCHAR2(4000 CHAR) | Specifies which exact answer to the selected question is used to assign subjects to the current branch, in case subjects are assigned to the branch by form question. |
\n BRANCH_ARM | VARCHAR2(32767 CHAR) | Specifies which treatment arm(s) correspond to the current branch, in case subjects are assigned to the branch by treatment arm. |
\n IS_CYCLE_BRANCH | CHAR(1) | States whether the branch is cycled. Possible values include Y or N. |
\n CYCLE_COUNT | NUMBER | Specifies the number of cycles in case the branch is cycled. |
\n ASSIGN_SUBJECT_USING_FORM_QUESTION | CHAR(1) | Indicates if subjects get assigned to branch by a form question. Possible values include Y or N. |
\n ASSIGN_SUBJECT_USING_TREATMENT_ARM | CHAR(1) | Indicates if subjects are assigned to the branch by Treatment arm. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(32) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(32 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_ORDER | NUMBER | An integer indicating a visit's ordinal position (order) within the visit schedule for the selected study version. These values may change across versions; for example, a visit that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new visit is inserted at position 3. Note: Ordinal values are study design attributes only and do not reflect a subject's progress through a study or carry clinical significance. About draft study versions: VISIT_ORDER values won't appear in the dataset for a draft study version until you either move the draft to the test container or choose Send to Analytics from the draft container menu. About visits: The dataset output displays scheduled (non-branch and branch) visits and unscheduled visits in the following manner. - Scheduled non-branch visits (for example, a screening visit) are listed first, followed by scheduled branch visits, and finally unscheduled visits when the
VISIT_ORDER is sorted in ascending order. - Scheduled branch visits are assigned an ordinal value that reflects their position in a branch. When sorted in ascending order, visits from earlier tiers appear before those in later ones.
Note: A tier, the highest level in visit branch design, is used to organize parallel branches, also called arms or cohorts. Each branch consists of a group of visits. For instance, a study includes two tiers (Tier1 and Tier2); each consists of two branches (BranchA and BranchB), and each branch contains a set of visits (Day1 and Day15). When sorted in ascending order, they appear as follows in the output. - Tier1.BranchA.Day1
- Tier1.BranchA.Day15
- Tier1.BranchB.Day1
- Tier1.BranchB.Day15
- Tier2.BranchA.Day1
- Tier2.BranchA.Day15
- Tier2.BranchB.Day1
- Tier2.BranchB.Day15
- Unscheduled visits, which include Withdrawal, Screen Fail, Rescreen, and Study Completion visits, are assigned an ordinal value based on the sequence defined on the Unscheduled Visit or Event sidebar and appear after scheduled branch visits when
VISIT_ORDER is sorted in ascending order.
|
\n VISIT_CREATION_ORDER | NUMBER | Indicates the order number the event was created in relation to when the study started. |
\n VISIT_HOUR_SEQ_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n EARLIEST_VISIT_TO_COMPLETE | VARCHAR2(64 CHAR) | When creating a study completion visit, you can specify an earlier visit that must be completed in order to enable the option for marking the subject as Complete. The reference name of that specified scheduled visit is provided in this field. This data element is added for each event. However, it is only specified when the record is for a Subject Completion event, while all other records display as a NULL value. |
\n SDV_VISIT_START | VARCHAR2(12) | This data element captures SDV settings for visit dates with the following possible values: NULLALL SUBJECTSTARGETED SDV
Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n ALERT_OUTSIDE_VISIT_WINDOW | VARCHAR2(16 CHAR) | Indicates if there is any rule set to alert if visit date is out of window. Values can be: |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_TYPE | VARCHAR2(14) | Indicates the type of form: One-section formTwo-section formLab form
|
\n FORM_ORDER | NUMBER | An integer indicating a form's ordinal position (order) within a visit for the selected study version. These values may change across versions; for example, a form that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new form is inserted at position 3. Note: Ordinal values are positive integers that indicate the sequence of forms in a visit as defined by the study design. They do not indicate if a form was started or completed and do not carry any clinical significance. About Advanced Study Versioning (ASV): Duplicate FORM_ORDER values appear in the output when a new form is added using Advanced Study Versioning (ASV) and the dataset is generated for a previous study version. For example, study version 1.0.0.1 includes three forms, and study version 1.0.0.2 introduces a new form (Vitals). The output appears as follows when the dataset is generated for version 1.0.0.1. However, if the dataset is generated for version 1.0.0.2, no duplicate values appear and the order is sequentially correct. |
\n FORM_IS_REPEATING | CHAR(1) | Indicates whether the form is repeating. Possible values include Y or N. |
\n ALLOW_MULTIPLE_INSTANCES | NUMBER | Indicates whether multiple instances of the same form can be added within a visit. Possible values include 0 or 1. |
\n ALLOW_ADDITIONAL_ROWS | CHAR(1) | Indicates if this is a repeating form or table that allows additional rows to be added. Possible values include Y or N. |
\n FORM_IS_ROLLOVER | CHAR(1) | Indicates whether the form is rollover. Possible values include Y or N. |
\n SOURCE_STUDY_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the name of the study it was copied from. |
\n SOURCE_STUDY_VERSION | VARCHAR2(32 CHAR) | If it is a copied form, indicates the study version of the study it was copied from. |
\n SOURCE_DATAVIEW_NAME | VARCHAR2(64 CHAR) | If it is a copied form, indicates the original form it was copied from. |
\n SOURCE_VERSION_START | TIMESTAMP(6) | If it is a copied form, indicates the date and time of when the copied data was entered. |
\n RULE_COPY_STATUS | NUMBER | If it is a copied form, indicates the status of the source form rules copy. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n DATA_TYPE | VARCHAR2(64 CHAR) | Indicates the data format of the collected data. Note: Data type refers to how collected data is stored, which is different from the question type that defines how the question is presented to the site user. Possible values include VARCHAR, NUMBER, or DATE. |
\n FORMAT | VARCHAR2(40 CHAR) | Specifies the answer format. For example an specific date format, or the number of decimals after the point. |
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n ITEM_GROUP | VARCHAR2(64 CHAR) | If this is a group question, indicates the group question title. |
\n ITEM_GROUP_ORDER | NUMBER | Indicates the order of items on two-section forms and in question group type questions. For example, a study's design includes a question group labeled Scan 1 with two questions: Scan Date and Upload Scan. In the design the group is treated as a single question, so in the output, the ITEM_GROUP and ITEM_ORDER are the same for each question in the group, and ITEM_GROUP_ORDER reflects each question's position within the group. For any other form or question types, ITEM_GROUP_ORDER is NULL. |
\n ITEM_ORDER | NUMBER | A numeric value indicating the ordinal position (order) of a question on a form for the selected study version. - Version-specific:
ITEM_ORDER reflects the order as defined in that specific study version. Values may change across study versions. For example, a question that is in position 3 in version 1.0.0.1 may shift to position 4 in a later version if a new question is inserted at position 3. - Not always an integer: In some study versions,
ITEM_ORDER may appear as a decimal value (for example, 2.001 or 4.001). This can occur when new items are inserted into an existing form in a particular study version (for example, items inserted after an existing question and associated with ASV). In these cases, the decimal value indicates the position of the inserted item relative to the prior item without renumbering all subsequent items in that version. - Latest version may be re-sequenced: When viewing a later or the latest study version, the same form may show a fully re-sequenced order using consecutive integers (for example,
1, 2, 3, 4, 5, 6).
In a later/latest study version, the order may be displayed as consecutive integers (for example): 1, 2, 3, 4, 5, 6 Note: Ordinal values indicate the sequence of questions on forms as defined by the study design for the selected study version. They do not indicate whether a question was answered and do not carry any clinical significance. About Age items on forms: When an Age item is added to a form, the system also adds a Date of Birth field and displays them together, making it appear as a single question in the study design. In the study design dataset, however, Age (a calculated item) and Date of Birth are recorded as two distinct items, each on its own row with a unique ordinal value. |
\n GROUP_TYPE | VARCHAR2(32 CHAR) | Indicates if this is a group question. Possible values include QuestionGroup, section, or table. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n CODE_QUESTION | VARCHAR2(32767 CHAR) | If the question has a Coding Question property, lists the following information: - Dictionary
- Coding Item Type
- Tag for Central Coding
|
\n ITEM_VALUES | VARCHAR2(32767) | The raw value of the form question value (can be an array in questions with decodes). Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. For more details see Form item output mapping in data extracts. |
\n CODELIST_VALUES | VARCHAR2(32767) | Lists the codelist values added as answers to the current question. Note: This value displays as NULL for dynamic codelists, because the form does not contain dynamic codelist values. Only the type (DYNAMIC) of the codelist is visible. |
\n CODELIST_LINK_TYPE | VARCHAR2(20) | Indicates whether choice questions are DYNAMIC or STATIC. This value displays as NULL for non-choice questions. |
\n CODELIST_LANG | VARCHAR2(5) | Indicates the selected language (English, Chinese, Japanese) for the code list values. Possible values include en, zh, or ja. |
\n FORMITEM_IS_REQUIRED | CHAR(1) | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include Y or N. |
\n READONLY | CHAR(1) | Indicates that the question is marked as read-only by a study designer. Possible values include Y or N. |
\n ALLOW_FUTURE_DATE | NUMBER(1) | For Date/Time questions. Indicates if the user is allowed to enter a future date. Possible values include 0 or 1. |
\n ITEM_DATE_PARTIAL_REQUIRED | VARCHAR2(32 CHAR) | Indicates the partial date format allowed when partial date entry is enabled for the question. |
\n HIDDEN | CHAR(1) | Indicates if a question is hidden, as marked by a study designer. Possible values include Y or N. |
\n DATA_CLASSIFICATION | VARCHAR2(2048 CHAR) | Indicates how the data is categorized according to its sensitivity and intended use. Applicable only to hidden items. This data element populates with a comma separated list of all the selected data classification groups of a hidden item. Possible values for this element include: Adjudication dataBlinded dataPII dataPublic dataSponsor data
|
\n EHR_MAPPING | VARCHAR2(32767 CHAR) | Displays the OCC data dictionary mapping value for a question mapped for Electronic Health Record (EHR) data import. |
\n VALIDATION_RULES | VARCHAR2(32767) | Specifies the question's validation rule if any. Validation rules types available depend on the type of question: - Text questions:
- Date/Time and Date of birth questions:
- After
- On or After
- Before
- On or Before
- On
- Not On
- Not Between
- Range
- Number and Age questions:
- Greater Than
- Greater Than or Equal To
- Less Than
- Less Than or Equal To
- Is
- Not Equal To
- Not Between
- Range
- Drop-down and checkboxes questions:
- Select at Least
- Select at Most
- Select Exactly
- Answer Must Be
- Radio Buttons questions:
|
\n RULE_ERROR | VARCHAR2(32767) | Reason for failure if validation status is failed or the rule validation failed. |
\n ACTION_RULES | VARCHAR2(32767 CHAR) | Details the action rule of a question which can be of the types: Show QuestionShow FormShow VisitLink & Show Form
|
\n APPLY_CHANGE_VERSION | VARCHAR2(32 CHAR) | Indicates the version in which changes to the form item apply. This data element refers to the lowest study version in which the change is applied. This means the change is included in all study versions between the APPLY_CHANGE_VERSION and the current study version. |
\n SDV | VARCHAR2(12) | Specifies if the question has any SDV parameter and if it is of the type SDV for All Subjects or Critical Variables (Targeted SDV). Possible values include ALL SUBJECTS, TARGETED SDV, or NOT DEFINED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n MODIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who last modified the study design record. |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the event from which the visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER | A number that represents the unique identifier of the form. |
\n ITEM_ID | RAW(16 BYTE) | GUID of the item. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n MODIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who modified the study design record. |
\n MODIFIED_BY_WID | NUMBER(10) | A number that represents the unique identifier of the user who modified the study. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n BRANCH_ID | RAW(16 BYTE) | Indicates the branch identifier associated with the row. |
\n BRANCH_WID | NUMBER(10) | A number that represents the unique identifier of the visit branch. |
\n SOURCE_DATAVIEW_WID | NUMBER | A number that represents the unique identifier of the source form data view in a reference copy rule. |
\n SOURCE_STUDY_WID | NUMBER | A number that represents the unique identifier of the source study in a reference copy rule. |
\n ITEM_GROUP_ID | NUMBER | Indicates the item group ID associated with the question. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"DataCollectionDataSetReport":{
"description":"DataCollectionDataSetReport",
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"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"IS_APPROVED",
"REASON_FOR_REVISION",
"VERSION_TITLE",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
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"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"VISIT_ORDER",
"EARLIEST_VISIT_TO_COMPLETE",
"FORM_ORDER",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_ORDER",
"ITEM_GROUP_ORDER",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"DATA_CLASSIFICATION",
"DATA_TYPE",
"APPLY_CHANGE_VERSION",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED",
"SDV_VISIT_START",
"CODELIST_LINK_TYPE",
"CODELIST_LANG"
],
"data":[
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"Study_01",
"N",
"57CCABE13C174836A48BCEDD46247AB8",
"107",
"Week2",
"WEEK2",
"Week2",
"Y",
"ScheduleAbleVisit",
"ONSITE",
"1",
"Sponsor Data",
"7",
"Y",
"Week1",
"3279AFB1AA3C44CFB6D6C419AAAC8A84",
"WEEK1",
"202",
"2",
"0",
"2",
"0",
"ALERT",
"21",
"0",
"864",
"5",
"301",
"Treatment Arm A",
"ARM_A",
"A1B2C3D4E5F6478AB9C0D1E2F3A4B5C6",
"N",
"0",
"Y",
"N",
"Arm A",
"ELIGIBILITY_FORM",
"Eligible for Arm A?",
"Yes",
"Screening",
"3ADB1375C6714B8C97CA14AFA175D739",
"73",
"FORM TO COLLECT MEASUREMENT VITAL SIGNS",
"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT",
"1 SECTION FORM",
"N",
"N",
"-1",
"N/A",
"-1",
"N/A",
"1.0",
"2025-01-01T00:00:00.000Z",
"0",
"0",
"8F70423FE2204ED5A3B0B00F363C3306",
"346",
"1",
"TARGETED SDV",
"Weight",
"Kilogram",
"Measurement",
"Enter weight in kg",
"Y",
"N",
"NUMBER_02",
"Weight",
"NUMBER_02",
"-1",
"VITALS",
"FORM",
"N",
"value>=0 and value<=300",
"Weight must be between 0 and 300 kg",
"OnChange:RecalculateBMI",
"N/A",
"REQUIRED",
"N",
"1",
"",
"",
"0",
"2025-10-29T13:03:20.263Z",
"NUMBER",
"",
"3",
"3099-12-31T00:00:00.000Z",
"2025-10-29T13:09:36.312Z",
"testuser1",
"33D0D74837F6454B836AAB5BA2574D28",
"9",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"{}",
"N",
"Y",
"N",
"N",
"N",
"VERSION",
"STATIC",
"en",
"en"
]
]
}
},
"DataCollectionDataSetEmptyReport":{
"description":"DataCollectionDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"STUDY_VERSION",
"STUDY_DESIGN_STATUS",
"IS_APPROVED",
"REASON_FOR_REVISION",
"VERSION_TITLE",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"VISIT_TYPE",
"EVENT_TYPE",
"VISIT_ORDER",
"EARLIEST_VISIT_TO_COMPLETE",
"FORM_ORDER",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_REFNAME",
"SCHEDULED_FROM_EVENT_WID",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"ALERT_OUTSIDE_VISIT_WINDOW",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_HOUR_SEQ_ORDER",
"VISIT_CREATION_ORDER",
"BRANCH_WID",
"BRANCH_TITLE",
"BRANCH_REFNAME",
"BRANCH_ID",
"IS_CYCLE_BRANCH",
"CYCLE_COUNT",
"ASSIGN_SUBJECT_USING_TREATMENT_ARM",
"ASSIGN_SUBJECT_USING_FORM_QUESTION",
"BRANCH_ARM",
"BRANCH_FORM",
"BRANCH_QUESTION",
"BRANCH_ANSWER",
"BRANCH_VISIT",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_TYPE",
"FORM_IS_REPEATING",
"ALLOW_ADDITIONAL_ROWS",
"SOURCE_DATAVIEW_WID",
"SOURCE_DATAVIEW_NAME",
"SOURCE_STUDY_WID",
"SOURCE_STUDY_NAME",
"SOURCE_STUDY_VERSION",
"SOURCE_VERSION_START",
"RULE_COPY_STATUS",
"ALLOW_MULTIPLE_INSTANCES",
"ITEM_ID",
"ITEM_WID",
"ITEM_ORDER",
"ITEM_GROUP_ORDER",
"ITEM_NAME",
"MEASURE_UNIT",
"QUESTION_TYPE",
"QUESTION_HINT",
"FORMITEM_IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"REFERENCE_CODE",
"ITEM_GROUP_ID",
"ITEM_GROUP",
"GROUP_TYPE",
"HIDDEN",
"VALIDATION_RULES",
"RULE_ERROR",
"ACTION_RULES",
"CODE_QUESTION",
"SDV",
"FORM_IS_ROLLOVER",
"FORMAT",
"ITEM_DATE_PARTIAL_REQUIRED",
"ITEM_VALUES",
"CODELIST_VALUES",
"ALLOW_FUTURE_DATE",
"DATA_CLASSIFICATION",
"DATA_TYPE",
"APPLY_CHANGE_VERSION",
"VERSION_START",
"VERSION_END",
"DH_TIMESTAMP",
"MODIFIED_BY",
"MODIFIED_BY_ID",
"MODIFIED_BY_WID",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_MAPPING",
"OCC_ENABLED",
"REQ_SCREENING",
"REQ_RANDOMIZE",
"REQ_DISPENSE",
"SAFETY_INTEGRATION_ENABLED",
"SDV_VISIT_START",
"CODELIST_LINK_TYPE",
"CODELIST_LANG"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v9.0-tenant-{tenantId}-studies-{studyId}-dataCollection-post",
"x-filename-id":"ec-datahub-svc-rest-v9.0-tenant-tenantid-studies-studyid-datacollection-post"
}
},
"/ec-datahub-svc/rest/v9.0/studies/{studyId}/{mode}/odm/clinicalData/blinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data without hidden data"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract blinded clinical data (excluding hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds new clinical one extension attributes 'WithdrawalDate' at the subject level if Date of Withdrawal is entered, 'CompletionDate' at the subject level if Date of Completion is entered, 'EHRLinkStatus' at the subject level if the subject is linked to EHR and 'EHRImported' if the data is captured from EHR at the item level transactions. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataBlinded_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v9.0-studies-{studyId}-{mode}-odm-clinicalData-blinded-get",
"x-filename-id":"ec-datahub-svc-rest-v9.0-studies-studyid-mode-odm-clinicaldata-blinded-get"
}
},
"/ec-datahub-svc/rest/v9.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for clinical data with hidden data"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead.
This API is used to extract unblinded clinical data (including hidden data) in the CDISC ODM-XML format. This extract includes subject, visit, item level, and query transactions. Additionally this version adds new clinical one extension attributes 'WithdrawalDate' at the subject level if Date of Withdrawal is entered, 'CompletionDate' at the subject level if Date of Completion is entered, 'EHRLinkStatus' at the subject level if the subject is linked to EHR and 'EHRImported' if the data is captured from EHR at the item level transactions. Note: If offset and limit parameters are used for pagination, the transactions will be grouped per subject.",
"operationId":"getClinicalDataUnblinded_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"string"
}
},
{
"name":"fileType",
"in":"query",
"description":"It accepts 'Snapshot' or 'Transactional' to indicate whether to include in the ODM Extract current data only (Snapshot) or incremental data changes with audit information (Transactional).
The default value is Transactional.",
"schema":{
"type":"string"
}
},
{
"name":"fromTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract after this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"toTimestamp",
"in":"query",
"description":"It includes data in the ODM Extract up until this timestamp. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format. FromTimestamp and ToTimestamp parameters are based on the dh_timestamp and not on the Clinical One version start timestamp. dh_timestamp is the time when the transaction/value was loaded into Data Hub warehouse. The dh_timestamp value is used to ensure that all values from the database are displayed in the extract.",
"schema":{
"type":"string"
}
},
{
"name":"excludeHiddenData",
"in":"query",
"description":"Indicates whether to exclude or include hidden data from the ODM Extract. The API will only return what the user is authorized to see in either case. This value is used to limit the data returned if the requester has access to all data. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which subject you want to start retrieving clinical data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"The number of subjects, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve subjects in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/ClinicalDataODMExtV1"
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
},
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v9.0-studies-{studyId}-{mode}-odm-clinicalData-unblinded-get",
"x-filename-id":"ec-datahub-svc-rest-v9.0-studies-studyid-mode-odm-clinicaldata-unblinded-get"
}
},
"/ec-datahub-svc/rest/v9.0/studies/{studyId}/{mode}/odm/metadata":{
"get":{
"tags":[
"Data Hub/ODM/ODM extract for meta data"
],
"summary":"V9.0",
"description":"This API is used to extract meta data in the CDISC ODM-XML format. This version introduces new Clinical One extension attribute 'DataClassification': Specifies the data classifications applied to hidden items and logic change for the attribute 'OrderNumber' of StudyEventRef to maintain the sequence as defined in the Clinical One.",
"operationId":"getMetadata_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"includeCOExtensions",
"in":"query",
"description":"If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"studyVersionSummary",
"in":"query",
"description":"If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.",
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"fromTimestamp",
"in":"query",
"description":"Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.",
"schema":{
"type":"string",
"format":"date-time"
},
"example":"2024-01-01T00:00:00Z"
},
{
"name":"studyVersion",
"in":"query",
"description":"The version of the study to extract data from in the ODM Extract.",
"schema":{
"type":"string"
},
"example":"1.0.0.1"
},
{
"name":"offset",
"in":"query",
"description":"An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/StudyODMExtV9"
},
"examples":{
"StudyMetadataResponse":{
"description":"StudyMetadataResponse",
"value":"STUDY01STUDY01STUDY01mgYearsmmHgcmKilogramkgKgEnableDynamicVisit?Association"
}
}
}
}
},
"400":{
"description":"'Missing / invalid data'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"ErrorResponseExample":{
"description":"ErrorResponseExample",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"INVALID_START_TIME",
"errorMessage":"Invalid fromTimestamp in the request url"
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v9.0-studies-{studyId}-{mode}-odm-metadata-get",
"x-filename-id":"ec-datahub-svc-rest-v9.0-studies-studyid-mode-odm-metadata-get"
}
},
"/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/blindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get blinded visit details"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Blinded Subject Event dataset for a single study and mode.
The dataset exposes blinded subject visit history, including site, subject, visit scheduling and status, transfer context, form completion counts, and audit columns, without exposing unblinded treatment assignment details.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: EHR_ENABLED.
Required permission: BlindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBERS in the orderColumns field of the request payload.
",
"operationId":"getBlindedSubjectDataset_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"BlindedSubjectEventDataSetQuery":{
"description":"BlindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"KIT_NUMBERS",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry reference data associated with the site's primary country for the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Oracle Clinical One Platform. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Oracle Clinical One Platform user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
|
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Indicates the event type as specified by the study designer when they created the event. Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own refname. For example, SCREENINGVISIT is displayed for the Screening Visit, as it is the first visit in the schedule. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include SIGNED or UNSIGNED. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that a standard visit has been started.Y (Yes) indicates that a standard (expected) visit has not been started.
Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit and randomization attributes associated with the blinded subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBERS | VARCHAR2(32767 CHAR) | Indicates a kit's number, as assigned in the system. |
\n RAND_NUMBER | VARCHAR2(40) | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nDerived counts summarizing related form activity for the subject visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment recorded for the visit row change. It can come from reason-for-change entry or from system processing. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | Audit trail number that increments when the underlying visit row is updated. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"BlindedSubjectEventDataSetReport":{
"description":"BlindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
[
"F99CCCACADCB4FF087D12EE943689BCA",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.2",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"Tester2",
"United States",
"1",
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"DATAHUB_AUT_Site2_Active01",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T13:31:11.372Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Visit completed",
"Auto-update on form submission",
"Y",
"2025-10-29T13:33:22.326Z",
"1",
"1",
"Screening_Initiated",
"DATAHUB_AUT_Site2_Screen01",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"10004567",
"KIT-000123",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"N",
"N",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"BlindedSubjectEventDataSetEmptyReport":{
"description":"BlindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"RAND_NUMBER",
"KIT_NUMBERS",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"FREEZE",
"VERIFIED",
"SIGNED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v9.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-blindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v9.0-tenant-tenantid-studies-studyid-mode-subjects-blindedvisits-post"
}
},
"/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"V9.0",
"description":"Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: ENROLLMENT_DATE.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectDataset_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"ENROLLMENT_DATE",
"STATE",
"STATE_DATE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE",
"WITHDRAWAL_REASON",
"WITHDRAWAL_COMMENT",
"REASON",
"COMMENT",
"SCREEN_FAILURE_DATE",
"SCREEN_FAILURE_COMMENT",
"SCREENING_FAILURE",
"RESCREEN_INSTANCE_NUM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N.
|
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n RESCREEN_INSTANCE_NUM | NUMBER | Instance number of the re-screening event for the subject. If this is the second time a subject is re-screened, the instance number would be 2. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_DATE | DATE | Indicates the date on which the subject was enrolled in the study. |
\n STUDY_COMPLETION_DATE | DATE | Date in which the subject completed the study. |
\n WITHDRAWAL_DATE | DATE | Date in which the subject got withdrawn from the study. |
\n SCREEN_FAILURE_DATE | DATE | Date in which the subject failed screening. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREEN_FAILURE_COMMENT | VARCHAR2(2048 CHAR) | Comment added by the site user for a subject's screen failure event. |
\n WITHDRAWAL_REASON | VARCHAR2(255 CHAR) | Reason provided for a subject's withdrawal from study. |
\n WITHDRAWAL_COMMENT | VARCHAR2(2048 CHAR) | Comment added by the site user for the subject's withdrawal event. |
\n EXTERNAL_SOURCE_STATUS_DATE | TIMESTAMP(6) | Indicates the date on which the subject status was updated by an external source. |
\n EHR_LINK_STATUS | CHAR(1) | Displays Yes or No, indicating if a subject is currently linked for Electronic Health Record (EHR) data import. Possible values include Y or N. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if the subject's data is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the aggregate verification status for the subject's data. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the subject. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"ENROLLMENT_DATE",
"STATE",
"STATE_DATE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE",
"WITHDRAWAL_REASON",
"WITHDRAWAL_COMMENT",
"REASON",
"COMMENT",
"SCREEN_FAILURE_DATE",
"SCREEN_FAILURE_COMMENT",
"SCREENING_FAILURE",
"RESCREEN_INSTANCE_NUM"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Screen01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"2025-10-22T09:30:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"DATAHUB_AUT_Site2_Active01",
"N",
"N",
"N",
"2025-10-29T13:00:00.000Z",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"343",
"test@abc.com",
"1234567891",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"N",
"D6F3EDE882AE4422AE3D8687E1CC9E14",
"20",
"Study Designer (template)",
"N",
"3099-12-31T00:00:00.000Z",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"Initial subject creation",
"Created via data hub load",
"3099-12-31T00:00:00.000Z",
"",
"N",
"0"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"ENROLLMENT_DATE",
"STATE",
"STATE_DATE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"SCREENING_NUMBER",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"FAX",
"EMAIL",
"PHONE",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SHIPPING_PHONE",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"EHR_ENABLED",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"EHR_LINK_STATUS",
"WITHDRAWAL_DATE",
"STUDY_COMPLETION_DATE",
"WITHDRAWAL_REASON",
"WITHDRAWAL_COMMENT",
"REASON",
"COMMENT",
"SCREEN_FAILURE_DATE",
"SCREEN_FAILURE_COMMENT",
"SCREENING_FAILURE",
"RESCREEN_INSTANCE_NUM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v9.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v9.0-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/formItems":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject form items data details"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Form Items dataset for a single study and mode.
The dataset exposes subject form-item transaction history, including captured values, typed/normalized value variants, validation state, item metadata, form and visit context, subject context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns item-level history rows as subject data is created, modified, removed, or otherwise updated over time.
This version additionally includes the following data points: SCREENING_NUMBER.
Required permission: SubjectFormItemsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, OUTER_REPEAT, and ITEM_ID in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormItemsDataset_12",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormItemsDataSetQuery":{
"description":"SubjectFormItemsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"DH_SUBJECT_FORMITEMS_ID",
"SUBJECT_EVENTINST_FORMITEM_WID",
"TRANSACTION_START",
"TRANSACTION_END",
"VALIDATION_STATUS",
"VALIDATION_FAILURE",
"VARIABLE_ID",
"ORIGINATOR_ID",
"VENDOR_CODE",
"VALUE",
"MEASURE_UNIT",
"NORMALIZED_VALUE",
"NORMALIZED_UNIT_ID",
"NUM_VALUE",
"FLOAT_VALUE",
"UTC_DATETIME_VALUE",
"MONTH_VALUE",
"DAY_VALUE",
"YEAR_VALUE",
"HOUR_VALUE",
"MINUTE_VALUE",
"SECOND_VALUE",
"PARENT_ID",
"PARENT_WID",
"PARENT_NAME",
"ROOT_ID",
"ROOT_WID",
"ROOT_NAME",
"DATA_FLAG",
"ITEM_D",
"ITEM_R",
"ITEM_F",
"ITEM_TYPE",
"PROPERTY_ID",
"PROPERTY_VERSION_START",
"QUESTION_TYPE",
"QUESTION_HINT",
"IS_REQUIRED",
"READONLY",
"SAS_VARIABLE",
"SAS_LABEL",
"IS_ROLLOVER",
"IS_REPEATING",
"REFERENCE_CODE",
"HIDDEN",
"ITEM_ID",
"ITEM_WID",
"ITEM_NAME",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"ITEM_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nForm item value context | Study context | Site context | Country context | Subject context | Event context | Form context | Item context | Required context | Audit context | Reference and system identifiers
\n\nForm item value context
\nCollected form-item values and normalized representations associated with the subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VALUE | VARCHAR2(4000 CHAR) | The raw value of the form question value (can be an array in questions with decodes). For more details see Form item output mapping in data extracts. |
\n NORMALIZED_VALUE | VARCHAR2(100 CHAR) | Currently not populated. |
\n NUM_VALUE | NUMBER | If the question type is a calculation, measurement, or number, this field is populated with that number. |
\n FLOAT_VALUE | NUMBER | Item value without decimal places, if precision is provided in the study design. |
\n UTC_DATETIME_VALUE | TIMESTAMP(6) | Indicates the date and time in UTC for a Date/Time type of question. |
\n ITEM_D | VARCHAR2(4000 CHAR) | Decoded raw value, with additional considerations according to data type. If the question has a code value, it is populated in this field. For more details see Form item output mapping in data extracts. |
\n ITEM_R | VARCHAR2(4000 CHAR) | The raw value: alphanumeric value as entered in Clinical One Cloud Service with no conversions. This includes data entry flags. For more details see Form item output mapping in data extracts. |
\n ITEM_F | VARCHAR2(4000 CHAR) | The formatted value: value as entered in Clinical One Cloud Service converted to the question data type as per form design. Values from text questions are formatted to remove all non-printable characters (such as tabs, carriage returns, newline characters, and leading or trailing white spaces). For more details see Form item output mapping in data extracts. |
\n YEAR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the year value (i.e. 2021). |
\n MONTH_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the numeric month value (1-12). |
\n DAY_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the day value (1-31). |
\n HOUR_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the hour value (0-23). |
\n MINUTE_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the minute value (0-59). |
\n SECOND_VALUE | NUMBER | If the question type is Date/Time, this field is populated with the second value (0-59). |
\n VALIDATION_STATUS | VARCHAR2(25 CHAR) | Indicates if a form item passed validation. For example, if the question was entered correctly and a rule was not broken. |
\n VALIDATION_FAILURE | VARCHAR2(4000 CHAR) | Reason for failure if validation status is failed or the rule validation failed. |
\n DATA_FLAG | RAW(16 BYTE) | Data-entry flag that supplements the raw item value (for example NA, ND, or UNK). |
\n VENDOR_CODE | VARCHAR2(100 CHAR) | Vendor-supplied code associated with the data element, when provided. |
\n TRANSACTION_START | DATE | A number that represents the unique identifier of the subject form item record. |
\n TRANSACTION_END | DATE | Date/time at which the transaction completed processing. |
\n SUBJECT_EVENTINST_FORMITEM_WID | NUMBER | A number that represents the unique identifier of the subject form item record. |
\n\n
\n\nParent topic: Section index
\n
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(2048 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include true or false. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include Y or N. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-specific site address fields exposed separately for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(400) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: ScreeningRandomizationDispensationNon-DispensationOptionalWithdrawalStudy Completion
Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_SCHEDULED_VISIT | VARCHAR2(4) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. |
\n IS_ROLLOVER | CHAR(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nItem context
\nQuestion-level configuration and collected item attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ITEM_NAME | VARCHAR2(4000 CHAR) | Indicates the title of the question, as entered by a study designer. |
\n ITEM_TYPE | VARCHAR2(255 CHAR) | The form item's question type. |
\n QUESTION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of question as defined by a study designer. For example: TextNumberAgeDate/timeDrop-downRadio buttonsCheckboxes
|
\n QUESTION_HINT | VARCHAR2(4000 CHAR) | Indicates information that a study designer provided as a hint to help answer a question. |
\n MEASURE_UNIT | VARCHAR2(64 CHAR) | Indicates the measure of unit specified by a study designer for a Number type of question. |
\n SAS_VARIABLE | VARCHAR2(32 CHAR) | Indicates the SAS Variable of a form defined by a study designer. |
\n SAS_LABEL | VARCHAR2(4000 CHAR) | Indicates the SAS Label of a form defined by a study designer. Possible values include Y or N. |
\n REFERENCE_CODE | VARCHAR2(64 CHAR) | Indicates a question's reference code. |
\n LAB_NAME | VARCHAR2(500 CHAR) | Indicates the associated lab name, when the item is part of a lab form. |
\n READONLY | NUMBER(1) | Indicates that the question is marked as read-only by a study designer. |
\n HIDDEN | NUMBER(1) | Indicates if a question is hidden, as marked by a study designer. |
\n HAS_QUERY | CHAR(1) | Indicates if there is a query raised against a question, irrespective of the status. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a question is frozen by a data manager or CRA. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the question's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
Note: VERIFY_REQUIRED and NOT_APPLICABLE are not currently supported statuses in Oracle Clinical One Analytics. Possible values include Y or N. |
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the item. |
\n IS_MISSING_ITEM | CHAR(1) | Flags rows that describe a missing question or item value. |
\n\n
\n\nParent topic: Section index
\n
\n\nRequired context
\nQuestion-level and visit-level requiredness indicators associated with the expected item and visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VISIT_IS_REQUIRED | VARCHAR2(4) | Indicates if a visit is required. Possible values include Y or N. |
\n IS_REQUIRED | NUMBER | Indicates if the question is required. Required questions must be answered in order to save the form that contains it. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. Possible values include Y or N. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Comment entered for changing the value. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | A number that represents the unique identifier of the event. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n PARENT_ID | RAW(16 BYTE) | Indicates the numeric representation of the item value. |
\n PARENT_WID | NUMBER | Numeric identifier of the parent record. |
\n ROOT_ID | RAW(16 BYTE) | GUID of the root-level grouping containing this item. |
\n ROOT_WID | NUMBER | Numeric identifier of the root record. |
\n ITEM_ID | RAW(16 BYTE) | Indicates the question type as specified by the study designer. |
\n ITEM_WID | NUMBER(10) | A number that represents the unique identifier of the item. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | A number that represents the unique identifier of the item. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | Indicates the current status of the subject in the study. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n PARENT_NAME | VARCHAR2(4000 CHAR) | Display name of the parent data element or section. |
\n ROOT_NAME | VARCHAR2(4000 CHAR) | Display name of the root-level grouping for this data point. |
\n PROPERTY_ID | RAW(16 BYTE) | Indicates the row position of the item. |
\n PROPERTY_VERSION_START | TIMESTAMP(6) | Timestamp that marks when the property version became valid. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n DH_SUBJECT_FORMITEMS_ID | RAW(16 BYTE) | Indicates the number of times the form has been repeated. |
\n VARIABLE_ID | RAW(16 BYTE) | Indicates the validation status of the item value. |
\n ORIGINATOR_ID | RAW(16 BYTE) | UUID of the system or user that initiated the transaction. |
\n NORMALIZED_UNIT_ID | RAW(16 BYTE) | Indicates the item value collected for the subject. |
\n LAB_ID | VARCHAR2(50 CHAR) | Indicates the associated lab ID, when the item is part of a lab form. |
\n FORM_SECTION_ID | RAW(16 BYTE) | A number that represents the unique identifier of the form. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
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"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_STATUS",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"INVESTIGATOR",
"LAB_ID",
"LAB_NAME",
"HAS_QUERY",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_ITEM"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v9.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-formItems-post",
"x-filename-id":"ec-datahub-svc-rest-v9.0-tenant-tenantid-studies-studyid-mode-subjects-formitems-post"
}
},
"/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/forms":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject forms data details"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject Forms dataset for a single study and mode.
The dataset exposes versioned subject form status history, including form repetition and rollover settings, entered-versus-total item counts, visit context, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-form rows for form instances captured across visits in the selected study and mode.
This version additionally includes the following data points: EHR_ENABLED.
Required permission: SubjectFormDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, FORM_ID, INNER_REPEAT, and OUTER_REPEAT in the orderColumns field of the request payload.
",
"operationId":"getSubjectFormsDataset_13",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectFormsDataSetQuery":{
"description":"SubjectFormsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
},
{
"columnName":"FORM_ID",
"sortOrder":"ASC"
},
{
"columnName":"INNER_REPEAT",
"sortOrder":"ASC"
},
{
"columnName":"OUTER_REPEAT",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Form context | Form association context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n EHR_ENABLED | CHAR(3) | Indicates if a site is currently enabled for Electronic Health Record (EHR) data import. No is displayed if EHR has never been enabled for a site or if a site was disabled for EHR. Possible values include Y or N. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_CompleteVisit_Date_ChangedVisitDateClearedVisitDateEnteredVisit_Not_StartedVisit_Skip_UndoneVisit_SkippedVisit_StartedVisit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change.
Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening Randomization Dispensation Non-Dispensation Optional Withdrawal Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(128) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm context
\nForm-level design or collected-form attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n FORM_NAME | VARCHAR2(64 CHAR) | The name of the form, as specified by the study designer. |
\n FORM_REFNAME | VARCHAR2(64 CHAR) | A form's reference name. |
\n FORM_STATUS | VARCHAR2(100) | The status of the given form. Can have one of the following values: COMPLETED: all required items are completed with no open queries.COMPLETED_WITH_ERROR: all required items are complete but the form has validation errors. Validation errors can happen when a Designer rule condition is not met.IN_PROGRESS: the form was never completed and has one or more required items not completed.IN_PROGRESS_WITH_ERROR: the form was never completed and has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.INCOMPLETE: the form was completed at some point but now it has one or more required items not completed.INCOMPLETE_WITH_ERROR: the form was completed at some point but now it has one or more required items not completed and the form has validation errors. Validation errors can happen when a Designer rule condition is not met.SCHEDULED: the form is new and has no data entered for it.DELETED: All questions in a form have been cleared and the form is considered deleted.BLANK: indicates null or not applicable.OPTIONAL: the form does not have any required or completed items.NEW: none of the items of the form have been completed yet. A form can only received this status if it is triggered by a question with a show form rule or if it is added as part of Advanced Study Versioning (ASV).
|
\n REPEAT_FORM_NUMBER | NUMBER | Refers to the form instance number of all applicable form types with repeating data: Two section forms: indicates the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: this value will be null.
|
\n REPEAT_SEQUENCE_NUMBER | NUMBER | Refers to the row instance number of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: indicates the repeating form number.
|
\n INNER_REPEAT | NUMBER | Refers to the Section Repeat values of all applicable form types with repeating data: Two section forms: unique numeric identifier of the row in the repeating section.Lab forms: unique numeric identifier of the row in the repeating section that captures lab tests and results.Repeating forms: this value will be null.
|
\n OUTER_REPEAT | NUMBER | Refers to the Form Repeat values of all applicable form types with repeating data: Two section forms: unique identifier of the non-repeating section of the form, the form instance number.Lab forms: defaulted to a value of 1.Repeating forms: unique numeric identifier of the repeating form.
|
\n IS_REPEATING | CHAR(1) | Indicates if it is a repeating form. Possible values include Y or N. |
\n IS_ROLLOVER | VARCHAR2(1) | Indicates whether the form contains a rollover type of question. Possible values include Y or N. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a form is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the form's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the form. |
\n IS_MISSING_FORM | CHAR(1) | N (No) indicates that a form has been started. Y (Yes) indicates that a form has not been started or all questions on that form were cleared/deleted. Dynamic and unscheduled forms only appear when the form has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nForm association context
\nLinkage fields that connect the current form record to its associated form or visit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n ASSOCIATED_FORM_NAME | VARCHAR2(64 CHAR) | The name of the associated form. |
\n ASSOCIATED_FORM_REFNAME | VARCHAR2(64 CHAR) | Indicates the reference code of the associated form. |
\n ASSOCIATED_FORM_TYPE | NUMBER | Indicates the form type of the associated form. Possible values include 0 or 1. |
\n ASSOCIATED_EVENT_NAME | VARCHAR2(64 CHAR) | The name of the associated event. |
\n ASSOCIATED_EVENT_INSTANCE_NUM | NUMBER | The unique identifier for an associated event. Note: If the visit is not UnScheduleAbleVisit, this field will not be populated with any value. |
\n ASSOCIATED_STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version of the associated form. |
\n ASSOCIATED_REPEAT_FORM_NUM | NUMBER | When association is with a repeating form, indicates the associated repeating form number. |
\n ASSOCIATED_REPEAT_SEQUENCE_NUM | NUMBER | When association is with a repeating form, indicates the associated sequence number. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_ITEMS | NUMBER | Number of total questions in a form. |
\n ENTERED_ITEMS | NUMBER | Number of questions answered in a form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject within the study. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit or event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n FORM_ID | RAW(16 BYTE) | GUID of the form. |
\n FORM_WID | NUMBER(10) | A number that represents the unique identifier of the form. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n SUBJECT_EVENT_INST_ID | RAW(16 BYTE) | GUID of the subject event instance. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the parent visit from which the associated visit was scheduled. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n ASSOCIATED_EVENT_ID | RAW(16 BYTE) | GUID of the associated event. |
\n ASSOCIATED_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the associated event. |
\n ASSOCIATED_FORM_ID | RAW(16 BYTE) | GUID of the associated form. |
\n ASSOCIATED_FORM_WID | NUMBER(10) | A number that represents the unique identifier of the associated form. |
\n SUBJECT_EVENTINST_FORM_WID | NUMBER | A number that represents the unique identifier of the subject form record. |
\n COUNTRY_WID | NUMBER(10) | A number that represents the unique identifier of the country associated with the site address. |
\n FORM_SECTION_ID | RAW(16 BYTE) | GUID of the form section. |
\n ASSOCIATED_FORM_SECTION_ID | RAW(16 BYTE) | GUID of the associated form section. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectFormsDataSetReport":{
"description":"SubjectFormsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"449C1F544353423BBBBDD20D41DBDE00",
"7",
"DATAHUB_AUT_Site2_Active07",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"1",
"137",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1F2E3D4C5B6A79808796A5B4C3D2E1F0",
"0",
"0",
"0",
"0",
"COMPLETED",
"N",
"N",
"4",
"3",
"2103",
"United States",
"Tester2",
"Y",
"2025-10-29T15:03:37.782Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"0000000000000000000000000000000A",
"53",
"testuser1",
"2025-10-29T15:11:33.049Z",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"N",
"A5FF9D4196FB4EDA9CB5E7EEAC66E325",
"19",
"Screening_Initiated",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"0",
"0",
"0",
"0",
"0",
"N",
"N",
"SIGNED",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"1",
"FC21BE51B8424A54907F2F3672E72C29",
"7",
"ScreeningForm",
"FORM_02",
"1",
"0",
"1.0.0.3",
"0A1B2C3D4E5F60718293A4B5C6D7E8F9",
"0",
"DATAHUB_AUT_Site2_Screen07",
"DATAHUB_AUT_Site2_Screen07",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)"
]
]
}
},
"SubjectFormsDataSetEmptyReport":{
"description":"SubjectFormsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"EVENT_ID",
"EVENT_WID",
"EVENT_INSTANCE_NUM",
"SUBJECT_EVENTINST_FORM_WID",
"FORM_ID",
"FORM_WID",
"FORM_NAME",
"FORM_REFNAME",
"FORM_SECTION_ID",
"REPEAT_SEQUENCE_NUMBER",
"REPEAT_FORM_NUMBER",
"OUTER_REPEAT",
"INNER_REPEAT",
"FORM_STATUS",
"IS_REPEATING",
"IS_ROLLOVER",
"TOTAL_ITEMS",
"ENTERED_ITEMS",
"COUNTRY_WID",
"COUNTRY_NAME",
"INVESTIGATOR",
"IS_CURRENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"DH_TIMESTAMP",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"EHR_ENABLED",
"SUBJECT_EVENT_INST_ID",
"SUBJECT_EVENT_INST_WID",
"SUBJECT_STATE",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_ORDER",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"FREEZE",
"VERIFIED",
"SIGNED",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ASSOCIATED_EVENT_ID",
"ASSOCIATED_EVENT_WID",
"ASSOCIATED_EVENT_NAME",
"ASSOCIATED_EVENT_INSTANCE_NUM",
"ASSOCIATED_FORM_ID",
"ASSOCIATED_FORM_WID",
"ASSOCIATED_FORM_NAME",
"ASSOCIATED_FORM_REFNAME",
"ASSOCIATED_FORM_TYPE",
"ASSOCIATED_REPEAT_SEQUENCE_NUM",
"ASSOCIATED_STUDY_VERSION",
"ASSOCIATED_FORM_SECTION_ID",
"ASSOCIATED_REPEAT_FORM_NUM",
"PREVIOUS_SUBJECT_NUMBER",
"SCREENING_NUMBER",
"IS_MISSING_FORM",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v9.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-forms-post",
"x-filename-id":"ec-datahub-svc-rest-v9.0-tenant-tenantid-studies-studyid-mode-subjects-forms-post"
}
},
"/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/{mode}/subjects/unblindedVisits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded visit details"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Unblinded Subject Event dataset for a single study and mode.
The dataset exposes unblinded subject visit history, including visit scheduling and status, study/site/subject context, treatment and randomization details, dispensation details, form completion counts, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns versioned subject-visit rows for subjects associated with the study and mode.
This version additionally includes the following data points: SCREENING_NUMBER and COUNT_OF_KITS.
Required permission: UnblindedSubjectEventDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID, SUBJECT_ID, EVENT_ID, EVENT_INSTANCE_NUM, and KIT_NUMBER in the orderColumns field of the request payload.
",
"operationId":"getUnblindedSubjectDataset_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedSubjectEventDataSetQuery":{
"description":"UnblindedSubjectEventDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"SUBJECT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_ID",
"sortOrder":"ASC"
},
{
"columnName":"EVENT_INSTANCE_NUM",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Kit context | Aggregation context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(100 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n UNBLIND_DATE | TIMESTAMP(6) | Indicates the date and time when the first code break was performed and the subject's treatment arm was unblinded. This value is a timestamp. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break date. |
\n UNBLIND_REASON | VARCHAR2(255 CHAR) | Reason provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break reason. |
\n UNBLIND_COMMENT | VARCHAR2(2048 CHAR) | Comment provided by the user when the first code break was performed and the subject's treatment arm was unblinded. Note: Even if subject undergoes multiple code breaks, this filed displays only the first code break comment. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100 CHAR) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n EVENT_INSTANCE_NUM | NUMBER | Indicates the unscheduled visit instance number as designed by the study designer. |
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n IS_REQUIRED | VARCHAR2(1 CHAR) | Indicates if the visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | VARCHAR2(1 CHAR) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if a visit is frozen by a data manager or CRA. Possible values include Y or N. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the visit's verification status. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified. NOT_APPLICABLE
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the event. Possible values include Y or N. |
\n IS_MISSING_VISIT | CHAR(1) | N (No) indicates that the visit is not considered missing. Y (Yes) indicates that the visit is considered missing. Dynamic, branching, and unscheduled visits only appear when the visit has been started, and data entry has occurred. |
\n\n
\n\nParent topic: Section index
\n
\n\nKit context
\nKit-design, inventory, randomization, dispensation, and treatment details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n TREATMENT_NAME | VARCHAR2(64 CHAR) | This data element is obsolete, use TREATMENT_ARM_TITLE instead. Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n INVENTORY_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include Y or N. |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | VARCHAR2(64 CHAR) | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation context
\nPre-aggregated counts and summary measures returned with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n FORM_TOTAL_COUNT | NUMBER | Count of all forms created as part of the study design. |
\n FORM_COMPLETED_COUNT | NUMBER | Count of completed forms. Repeating instances are only counted once, meaning that repeating rows are not counted as an additional completed form. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject event instance. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n EVENT_ID | RAW(16 BYTE) | A number that represents the unique identifier of the subject. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n SCHEDULED_FROM_EVENT_ID | RAW(16 BYTE) | GUID of the previously scheduled event. |
\n SCHEDULED_FROM_EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the parent visit from which the associated visit was scheduled. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER | Indicates a user's numeric identifier. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID that represents the treatment arm. |
\n TREATMENT_WID | NUMBER | Numeric identifier that represents the treatment arm. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | Indicates whether a subject has been randomized in the study. |
\n COHORT_WID | NUMBER | A number that represents the unique identifier of the cohort. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Unblinded Subject Event dataset record. |
\n SUBJECT_EVENT_INST_WID | NUMBER | A number that represents the unique identifier of the subject event instance. |
\n INVENTORY_ID | RAW(16 BYTE) | A number that represents the unique identifier of the cohort. |
\n KIT_TYPE_SRC_ID | RAW(16 BYTE) | Indicates the kit number associated with the dispensed inventory item. |
\n INVENTORY_STATUS_ID | NUMBER | Numeric identifier that maps to the kit inventory status. |
\n MHEALTH_DEVICE_ID | RAW(16 BYTE) | Indicates a kit's status in the study's inventory. |
\n RND_STATUS_ID | NUMBER | Indicates the treatment associated with the subject randomization. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedSubjectEventDataSetReport":{
"description":"UnblindedSubjectEventDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS"
],
"data":[
[
"7550C1E7E3CA4B8CAD09ACD1F1E7F580",
"37",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"SCREENING",
"Visit_Complete",
"1",
"Tester2",
"United States",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"2025-10-28T09:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"2025-10-28T09:00:00.000Z",
"0",
"1",
"Y",
"FD227430BECA4DECA5EA8B0E4DBE18CA",
"16",
"ScreeningForm",
"SCREENINGFORM",
"0",
"0",
"0",
"0",
"0",
"0",
"2025-10-29T17:27:52.908Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"5",
"5",
"Auto-update on completion",
"System updated visit after form submit",
"Y",
"2025-10-29T17:32:36.385Z",
"A3E4B2D1C0F94A4E9D3B7C6A8F1E2D34",
"101",
"Arm A",
"10007890",
"2025-10-29T17:00:00.000Z",
"1",
"Randomized",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"9C8B7A6D5E4F4A1B8C7D6E5F4A3B2C1D",
"KIT-000457",
"11223344556677889900AABBCCDDEEFF",
"10",
"Dispensed",
"2025-10-29T17:15:00.000Z",
"7F6E5D4C3B2A19008F7E6D5C4B3A2910",
"1",
"BC1234567890",
"Yes",
"70 kg",
"Once Daily",
"0",
"0",
"N",
"Syringe kit 5 mL",
"1",
"1",
"1",
"Complete",
"DATAHUB_AUT_Site2_Active",
"Active",
"Study01",
"Study01",
"STUDY01",
"IV",
"Observational",
"Vaccines",
"ScreeningForm",
"SCREENINGFORM",
"SCR",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"N",
"VERIFY_REQUIRED",
"N",
"0",
"Treatment Arm A",
"Arm A dosing schedule",
"3099-12-31T00:00:00.000Z",
"Not Applicable",
"",
"DATAHUB_AUT_Site2_Screen13",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N",
"1"
]
]
}
},
"UnblindedSubjectEventDataSetEmptyReport":{
"description":"UnblindedSubjectEventDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_EVENT_INST_WID",
"STUDY_ID",
"STUDY_WID",
"STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SUBJECT_ID",
"SUBJECT_WID",
"EVENT_ID",
"EVENT_WID",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"EVENT_INSTANCE_NUM",
"INVESTIGATOR",
"COUNTRY_NAME",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"VISIT_ORDER",
"IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_ID",
"SCHEDULED_FROM_EVENT_WID",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_NAME",
"RAND_NUMBER",
"RANDOMIZATION_DATE",
"RND_STATUS_ID",
"RND_STATUS",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"INSTANCE_NUMBER",
"INVENTORY_ID",
"KIT_NUMBER",
"KIT_TYPE_SRC_ID",
"INVENTORY_STATUS_ID",
"INVENTORY_STATUS",
"DISPENSATION_DATE",
"MHEALTH_DEVICE_ID",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"KIT_DESCRIPTION",
"QUANTITY",
"FORM_TOTAL_COUNT",
"FORM_COMPLETED_COUNT",
"SUBJECT_STATE",
"SITE_ID_NAME",
"SITE_STATUS",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"BLINDING_TYPE",
"THERAPEUTIC_AREA",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"FREEZE",
"VERIFIED",
"SIGNED",
"TITRATION",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"UNBLIND_DATE",
"UNBLIND_REASON",
"UNBLIND_COMMENT",
"SCREENING_NUMBER",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"IS_MISSING_VISIT",
"COUNT_OF_KITS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v9.0-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-unblindedVisits-post",
"x-filename-id":"ec-datahub-svc-rest-v9.0-tenant-tenantid-studies-studyid-mode-subjects-unblindedvisits-post"
}
},
"/ec-datahub-svc/rest/v9.0/tenant/{tenantId}/studies/{studyId}/{mode}/unblindedKits":{
"post":{
"tags":[
"Data Hub/Datasets/Get unblinded kits for study"
],
"summary":"V9.0",
"description":"Retrieves the study-permissioned Unblinded Kits dataset for a single study and mode.
The dataset exposes unblinded kit inventory and dispensation history, including study, site, subject, randomization, treatment arm and dosing details, shipment/lot information, inventory status transitions, verification/confirmation metadata, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns rows at inventory level for unblinded kits associated with the study and mode.
This version additionally includes the following data points: COMPOUNDING_KITS.
Required permission: UnblindedKitsDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and INVENTORY_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveUnblidedKitsDataSetQuery_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":100
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32",
"example":0
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"UnblindedKitsDataSetQuery":{
"description":"UnblindedKitsDataSetQuery",
"value":{
"selectColumns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"COMPOUNDING_KITS"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
},
{
"columnName":"INVENTORY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Randomization context | Lot context | Shipment context | Kits context | Calculated dose context | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_TYPE | VARCHAR2(50 CHAR) | Indicates the type of organization. Possible values include Hospital, Teaching Hospital, Medical Clinic, or Other. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n SCREENING_NUMBER | VARCHAR2(500 CHAR) | Always displays the original screening number, assigned to the subject at screening. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n SUBJECT_STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nVisit metadata, scheduling rules, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TITLE | VARCHAR2(64 CHAR) | The event's title, defined by the user when an event is created. |
\n EVENT_ID_NAME | VARCHAR2(16 CHAR) | The event's id as in Clinical One Cloud Service. |
\n EVENT_REFNAME | VARCHAR2(64 CHAR) | The event's reference name. Displays a capitalized version of the (user entered) EVENT_TITLE with blank spaces removed. Oracle Clinical One Analytics generates this value, which is not displayed in the Clinical One Cloud Service user interface. Note: This value does not change if the associated EVENT_TITLE is updated in a subsequent Study Version. |
\n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a visit's status. Upon selecting this data element, only events that occurred in your study are displayed. For example, you may see some of the following events: Visit_Complete; Visit_Date_Changed; VisitDateCleared; VisitDateEntered; Visit_Not_Started; Visit_Skip_Undone; Visit_Skipped; Visit_Started; Visit_Inserted: this option refers to new visits inserted into the study's schedule as an Advanced Study Versioning change. Possible values include Visit Started, Visit Completed, Visit Not Done, or Visit Missed. |
\n VISIT_TYPE | VARCHAR2(100 CHAR) | Displays the type of visit: Screening; Randomization; Dispensation; Non-Dispensation; Optional; Withdrawal; Study Completion Possible values include ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, or ReScreeningEvent. |
\n VISIT_STATUS | VARCHAR2(32 CHAR) | Indicates a visit's status in the system. Can have one of the following values: NEW: the visit was dynamically triggered and has no data.SCHEDULED: the visit is scheduled for the subject but has no data. Note: Future visits are included with the status of SCHEDULED. Dynamic and cycle visits will not be included until an event happens that causes their creation on the subject's schedule.INPROGRESS: the visit was never completed and has one or more required items with no saved data.INCOMPLETE: the visit was completed at some point but now has one or more required items that are not completed.INCOMPLETE_ERR: the visit was completed at some point but now has one or more required items that are not completed and open queries.COMPLETE: all required items within the visit are completed and there are no open queries.COMPLETE_ERR: all required items within the visit are completed but there are open queries.SKIPPED: the visit was part of the visit schedule for the subject but was skipped by a site user.UNDO_SKIP: the visit was skipped at some point but the skip action was undone.
|
\n VISIT_ORDER | NUMBER | The order in which subject visits occur, as configured in the study design. |
\n VISIT_IS_REQUIRED | CHAR(1) | Indicates if a visit is required. Possible values include 0 or 1. |
\n IS_SCHEDULED_VISIT | CHAR(1) | Indicates if the visit is scheduled. Possible values include Y or N. |
\n SCHEDULED_FROM_EVENT_NAME | VARCHAR2(64 CHAR) | Displays the EVENT_TITLE (visit title) of the Scheduled From visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with the visit's own title. For example, Screening Visit is displayed for the Screening Visit, if it is the first visit in the schedule. |
\n SCHEDULED_FROM_EVENT_REFNAME | VARCHAR2(64 CHAR) | Displays the EVENT_REFNAME of the Scheduled From Visit as defined in the Visit Schedule. Note: If a visit is not scheduled or it is the first visit in the schedule, then this element is populated with that visit's own refname.. |
\n VISIT_START_DATE | DATE | Date stamp of a visit's start date. |
\n PROJECTED_VISIT_START_DATE | TIMESTAMP(6) | Date when the next scheduled visit should start in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_END_DATE | TIMESTAMP(6) | Date when the next scheduled visit should end in the study, based on the configured visit schedule. |
\n PROJECTED_VISIT_DATE | TIMESTAMP(6) | Date when the next scheduled visit should take place in the study, based on the configured visit schedule. |
\n DELAY_DAYS | NUMBER | The number of days between the prior scheduled visit. |
\n DELAY_HOURS | NUMBER | The number of hours between the prior scheduled visit (in addition to the DELAY_DAYS field). |
\n VISIT_WINDOW_BEFORE_DAYS | NUMBER | Indicates how many days before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_BEFORE_HOURS | NUMBER | Indicates how many hours before the scheduled date and time the visit can occur, as entered by a study designer. |
\n VISIT_WINDOW_AFTER_DAYS | NUMBER | Indicates how many days after the scheduled date and time the visit can occur. |
\n VISIT_WINDOW_AFTER_HOURS | NUMBER | Indicates how many hours after the scheduled date and time the visit can occur. |
\n\n
\n\nParent topic: Section index
\n
\n\nRandomization context
\nRandomization, cohort, treatment-arm, and allocation settings associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n RANDOMIZATION_TITLE | VARCHAR2(64 CHAR) | Indicates the title of a randomization strategy, as specified by a study designer in Clinical One Cloud Service. |
\n RANDOMIZATION_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the description a study designer provides in the Description field, on the Create Randomization dialog. Creating a randomization is done in Study Design mode. |
\n RANDOMIZATION_TYPE | VARCHAR2(32 CHAR) | Indicates the type of randomization, as specified by a study designer when creating a randomization: Blinded: if blinded users should never see any of the titles of the treatment arms used in the randomization design. Unblinded: if users should be aware of the titles of the treatment arms used in the randomization design. |
\n COHORT_NAME | VARCHAR2(64 CHAR) | Indicates the name of the cohort as defined by the study designer when creating a randomization design. |
\n TREATMENT_ARM_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the treatment arm from the protocol, as specified by the study designer in Clinical One Cloud Service. Displays the title for every treatment arm created in the study. |
\n TREATMENT_ARM_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates the additional details provided by a study designer in the Description field, when they created the treatment arm in Study Design mode. |
\n TREATMENT_ARM_ID | VARCHAR2(64 CHAR) | Indicates the short name that helps a user identify a treatment arm, such as A or Active 1, as specified by the study designer when they created the treatment arm. |
\n RAND_NUMBER | NUMBER | Indicates the randomization number assigned to each randomized subject in a study. Note: If the Blind Randomization Number option in your study's settings is set to Yes, data for this field displays as Blinded. For more information, see Specify study, enrollment, and visits settings. |
\n RND_STATUS | VARCHAR2(64 CHAR) | Indicates the randomization status for the subject's randomization number. Can have one of the following values: Assigned: the subject has a randomization number assigned.Randomized in error: the subject was randomized in error.
|
\n RANDOMIZATION_DATE | TIMESTAMP(6) | Indicates the date on which a subject has been randomized in the study. |
\n RERANDOMIZATION | NUMBER | Indicates whether the study designer chose to use the current randomization design for a second or later randomization event in the study. Values can be 1 or 0. |
\n FORCED_RAND | CHAR(1) | Indicates whether the subject underwent forced randomization. This helps track how many times forced randomization has been used over the course of the study. This scenario can occur due to a lack of kits for at least one treatment arm in the study at the time of randomization. For this data element, the following values can be displayed: Y: Indicates that a subject underwent forced randomization.N: Indicates that a subject was randomized normally.NULL: Indicates that a subject has not yet been randomized.
|
\n RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that subjects can only be assigned to specific treatment arms during randomization if the associated kit types are available. This would result in forced randomization to a specific treatment arm if the kits for a different treatment arm are not in stock.0: Indicates that a study designer chose not to restrict the randomization to available kit types. When randomization is not restricted, a subject can be randomized to a given treatment arm regardless of site inventory and may result in dispensation failure when there are no available kit types to dispense.
|
\n ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS | NUMBER | Indicates the option that a study designer chose (1 or 0) when configuring this setting. 1: Indicates that, when a randomization number is skipped due to forced randomization, the skipped randomization number may be subsequently assigned to a subject who enrolls after.0: Indicates that skipped randomization numbers are never assigned to subjects.
|
\n\n
\n\nParent topic: Section index
\n
\n\nLot context
\nLot identifiers, expiration controls, and supply-state attributes associated with the row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n BLINDED_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a blinded lot, as specified by a clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative blinded lot label, as specified by the clinical supply manager when they created the blinded lot. A blinded lot short name can be used when multiple depots use the same lot and have different naming conventions. One depot can use the title of a blinded lot, whereas another depot can use the short name. |
\n BLINDED_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the entire blinded lot, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n BLINDED_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_TITLE | VARCHAR2(64 CHAR) | Indicates the unique name of a manufacturing lot title, as specified by a clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_SHORT_NAME | VARCHAR2(64 CHAR) | Indicates an alternative manufacturing lot label, as specified by the clinical supply manager when they created the manufacturing lot. A manufacturing lot short name can be used when your organization's labeling conventions differ from the lot name supplied by the depot. |
\n MANFACTURING_LOT_EXPIRATION_DATE | DATE | Indicates the expiration date for the kits in the manufacturing lot, as specified by the clinical supply manager when they created the manufacturing lot. |
\n MANFACTURING_LOT_DO_NOT_COUNT_DAYS | NUMBER | Indicates the number of days before the expiration date when the kit is no longer counted in a site's inventory, as specified by the clinical supply manager when they created the blinded lot. |
\n MANFACTURING_LOT_DO_NOT_SHIP_DAYS | NUMBER | Indicates the number of days before the expiration date when a kit can no longer be shipped from a depot to a site, as specified by the clinical supply manager when they created the manufacturing lot. |
\n\n
\n\nParent topic: Section index
\n
\n\nShipment context
\nShipment lifecycle, receipt, and tracking details associated with kit distribution.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SHIPMENT_NAME | VARCHAR2(64 CHAR) | Indicates a shipment's full name. |
\n ORDER_TYPE | VARCHAR2(50 CHAR) | Indicates how a shipment was initiated: INITIAL; MANUAL; RESUPPLY |
\n SHIPMENT_STATUS | VARCHAR2(64 CHAR) | Indicates the status of a shipment, as updated by the system or by a user in the study: Pending; In Transit; Received; Cancelled; Lost; Confirmed; Invalid; Pending Destruction; Received for Destruction; Destroyed Possible values include PENDING, IN TRANSIT, RECEIVED, CANCELLED, LOST, CONFIRMED, INVALID, PENDING DESTRUCTION, RECEIVED FOR DESTRUCTION, or DESTROYED. |
\n TRACKING_NUMBER | VARCHAR2(64 CHAR) | Indicates a shipment's tracking number, as specified by the depot user. |
\n SHIPMENT_CREATED_DATE | TIMESTAMP(6) | Indicates the date a shipment was created, whether it is a: Manual shipment: this is a shipment that is created by either a depot or sponsor user. The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). Automatic shipment: this is a shipment that is automatically created and sent based on the study's resupply strategy (as designed by the clinical supply manager) or based on a study's integration with a clinical depot facility (as designed by your Oracle point of contact). The date during which the shipment was created in displayed in Coordinated Universal Time (UTC). |
\n SHIPMENT_DATE | TIMESTAMP(6) | Indicates a shipment's ship date, either automatically specified by an integration with the clinical depot facility or manually specified by someone from either the sponsor or depot. |
\n COMPOUNDING_KITS | VARCHAR2(1) | Indicates whether a shipment contains compounding kits: Y: the shipment does contain compounding kits. N: the shipment does not contain compounding kits. |
\n\n
\n\nParent topic: Section index
\n
\n\nKits context
\nInventory, dispensing, dosing, and verification fields associated with the kit or subject record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n KIT_NUMBER | VARCHAR2(1024 CHAR) | Indicates a kit's number, as assigned in the system. |
\n ITEM_NUMBER | VARCHAR2(64 CHAR) | Numeric value used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n BAR_CODE | VARCHAR2(1000 CHAR) | If included in a study, this indicates a kit's bar code as generated by the system. |
\n MATERIAL_ID | VARCHAR2(64 CHAR) | Alphanumeric identifier of the material of a given kit, used as a reference element for batch processing. Note: This field is part of the SAP system and populated via integration. This field does not display in Clinical One Cloud Service. |
\n SEQUENCE_NUMBER | NUMBER | Indicates a kit's sequence number, as specified by a clinical supply manager when setting up whether kits should be dispensed by sequence. |
\n BLOCK_NUMBER | VARCHAR2(512 CHAR) | Indicates the block number of randomization assigned to a site, country or region, for fixed randomization designs. |
\n KIT_DESCRIPTION | VARCHAR2(4000 CHAR) | Indicates a kit's description, as specified by the study designer when they created the kit type. |
\n KIT_TYPE | VARCHAR2(1020) | A kit's type, as specified by the study designer when they created the kit. The following values can be displayed: Investigation ProductDeviceKit Type Titration
|
\n KIT_TYPE_ID | VARCHAR2(64 CHAR) | Indicates the unique identifier for a kit type. |
\n KIT_STATUS | VARCHAR2(64 CHAR) | Indicates a kit's status in the study's inventory. For more information on what a kit's status may be, see What statuses can kits have? |
\n INSTANCE_NUMBER | NUMBER | Indicates the repeat instance number of the visit. |
\n DOSAGE | NUMBER | Indicates the dosage for the dispensed kit, when the kit contains calculated doses. |
\n FREQUENCY | VARCHAR2(64 CHAR) | Indicates the dosing frequency as defined by a study designer. |
\n MEASUREMENT | VARCHAR2(1000 CHAR) | Indicates the total numeric value for the product in a kit with calculated doses, as defined by a study designer. |
\n TRIAL_SUPPLY_TYPE | VARCHAR2(16 CHAR) | Indicates the supply type of the kit, as specified by the study designer. The following values can be displayed: Blister Pack; Bottle; Device; Syringe; Topical Ointment; Vial; Inhaler; Infusion; Box; Other |
\n TITRATION | NUMBER | Indicates if a kit type is part of a kit type titration. Values can be 1 or 0. |
\n MINIMUM_KITS_TO_SHIP | NUMBER | Indicates the minim number of kits to include in each shipment to meet packaging requirements, as specified by the study designer when they created the kit type. |
\n QUANTITY | NUMBER | Indicates a kit's quantity, as specified by the study designer. |
\n UNITS_PER_KIT | NUMBER | Indicates the number of units in the kit, such as the number of pills in a bottle, as specified by the study designer. For more information on this value, see Define the kits for investigational products. |
\n SINGLE_UNIT_DOSE_VALUE | NUMBER(20,2) | Indicates the value of a single unit in the kit. For example, if the kit is a blister pack, it would indicate how many milligrams of product are contained in 1 capsule. |
\n SINGLE_UNIT_DOSE_UNITS | VARCHAR2(16 CHAR) | Indicates how one unit in the kit is measured. For example: g, mg, ml, etc. |
\n BALANCE_UNITS | NUMBER | Indicates the total units of a kit minus the missing and returned units. |
\n RETURNED_UNITS | NUMBER | Number of units remaining in the kit as indicated by the site user or Clinical Research Associate (CRA) |
\n MISSING_UNITS | NUMBER | Number of lost or damaged units in the kit as indicated by the site user. |
\n COUNT_OF_KITS | NUMBER | The total count of kits. |
\n CALCULATING_DOSES | NUMBER | Indicates whether the study designer specified that the kit type should have calculated doses defined based on subjects' answers to one or more questions. The following values can be displayed: 1 or 0. |
\n IS_NON_SERIALIZED_KIT | CHAR(1) | Indicates if the kit is non serialized: Y (Yes) the kit is non-serialized. N (No) the kit is serialized. |
\n CONSERVED | VARCHAR2(16 CHAR) | Indicates whether a kit was conserved by a site user. Possible values include true or false. |
\n DEVICE_TYPE | VARCHAR2(255) | Indicates the type of device, as specified by the study designer when they created the device kit type. The following values can be displayed: Activity Watch; Blood Pressure Monitor; Glucose Monitor; Weight Scale; ECG Reader; Spirometer; Mobile App; Smart Pill Bottle; Pulse Oximeter; Wearable Patch; Other |
\n DEVICE_CONNECTION | VARCHAR2(255) | Indicates the type of device connection, as specified by the study designer when they created the device kit type. The following values can be displayed: No ConnectionDevice to CloudCloud to Cloud
|
\n DISTRIBUTION_SETTINGS | VARCHAR2(16 CHAR) | Indicates the type of distribution a kit has, as specified by the study designer. The following values can be displayed: Blinded: If blinded users should never see the kit type description.Unblinded: If users should always be aware of the kit type description.Unblinded Pharmacist: If blinded users should never see these kits at all and only pharmacists or unblinded site users can dispense these kit types.
|
\n CRA_VERIFIED | NUMBER | Indicates whether a question, a form, or a visit has been verified by a Clinical Research Associate (CRA). |
\n DISPENSATION_DATE | TIMESTAMP(6) | Indicates a kit's dispensation date, as entered by a site user when they dispensed the kit to a subject. |
\n DISPENSATION_CONFIRMED | NUMBER | Indicates whether a kit's dispensation was confirmed by a site user. Possible values include 0 or 1. |
\n CONFIRMED_DATE | TIMESTAMP(6) | Indicates the date at which a specified kit's dispensation was confirmed. |
\n CONFIRMED_BY | VARCHAR2(255 CHAR) | Indicates the email address of the user who confirmed the dispensation of a specified kit. |
\n VERIFIED_DATE | TIMESTAMP(6) | Indicates the date when inventory was verified. Date is displayed in UTC. |
\n VERIFIED_BY | VARCHAR2(255 CHAR) | Indicates the user who verified inventory data. |
\n\n
\n\nParent topic: Section index
\n
\n\nCalculated dose context
\nCalculated-dose configuration and measured values associated with dose determination for the dispensed kit.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n CALCULATED_DOSE_TITLE | VARCHAR2(64 CHAR) | Indicates the title of the kit type containing calculated doses, as specified by the study designer. |
\n FORM_QUESTION_FOR_CALCULATED_DOSE | VARCHAR2(64 CHAR) | Indicates the question that is selected by the study designer to be used in calculating the appropriate dose. |
\n VISIT_WHERE_FORM_IS_COLLECTED | VARCHAR2(64 CHAR) | Indicates the visit in which the question that is used to calculate the appropriate dose is asked, as specified by the study designer. |
\n SUBJECT_MEASUREMENT | NUMBER(20,2) | Indicates the value that, along with the answer for the subject and the value of a single unit, determines the dose, as specified by the study designer. |
\n KIT_MEASUREMENT | NUMBER(20,2) | Indicates the total numeric value for the product in the kit, as specified by the study designer. |
\n DOSE_FREQUENCY | VARCHAR2(21 CHAR) | Indicates how many doses the subject must consume, as specified by the study designer. |
\n DOSE_PRECISION | NUMBER | Indicates the number of places after the decimal point that each dose should be calculated in, as specified by the study designer. For example, if the precision for each dose is 0.0001, this value displays the number 4. |
\n DOSE_ROUND_UP | NUMBER | Indicates how the rounding is performed to reach the dose precision, as specified by the study designer. This field displays a whole number indicating the minimal decimal value to round-up and reach dose precision. For example, if the precision for each dose is 0.0001 and the round up is 0.00006 (as entered in the Clinical One Cloud Service): For the dose precision, the number 4 is displayed, this value represents the number of places after the decimal point. For the dose round up, the number 6 is displayed. |
\n DOSE_LEFT_OVER_UNITS | NUMBER | Indicates whether leftover units from a previous dose can be used in a next dose, during the study conduct period, as specified by the study designer. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n CURRENT_STUDY_ROLE_NAME | VARCHAR2(100 CHAR) | Current study role name of the user who updated the dataset row. If the user's study role changes later, this field shows the user's current study role. |
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment captured when \"Other\" is chosen as the change reason; rule-executed values also populate this field. |
\n IS_CURRENT | VARCHAR2(1 CHAR) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n SUBJECT_ID | RAW(16 BYTE) | GUID of the subject. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n TREATMENT_ID | RAW(16 BYTE) | GUID of the treatment assigned to the subject. |
\n TREATMENT_WID | NUMBER(10) | Numeric identifier of the treatment. |
\n EVENT_ID | RAW(16 BYTE) | GUID of the visit event. |
\n EVENT_WID | NUMBER(10) | A number that represents the unique identifier of the event. |
\n CALCULATED_DOSE_ID | RAW(16 BYTE) | GUID of the calculated dose configuration. |
\n CALCULATED_DOSE_WID | NUMBER(10) | Numeric identifier of the calculated dose configuration. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n VERIFIED_BY_ID | RAW(16 BYTE) | GUID of the user who verified the kit. |
\n VERIFIED_BY_WID | NUMBER | Numeric identifier of the verifying user. |
\n CONFIRMED_BY_ID | RAW(16 BYTE) | GUID of the user who confirmed the kit dispensation. |
\n CONFIRMED_BY_WID | NUMBER | Numeric identifier of the confirming user. |
\n CURRENT_STUDY_ROLE_ID | RAW(16 BYTE) | The ID associated with the study role assigned to the user who updated the given record. If the user study role changes, this field will show the current study role ID of the given user. |
\n CURRENT_STUDY_ROLE_WID | NUMBER(10) | Numeric identifier of the role of the user who updated the given record. If the user study role changes, this field will show the current study role of the given user. |
\n COHORT_ID | RAW(16 BYTE) | GUID of the cohort assigned to the subject. |
\n COHORT_WID | NUMBER(10) | A number that represents the unique identifier of the cohort. |
\n SHIPMENT_ID | RAW(16 BYTE) | GUID of the shipment. |
\n SHIPMENT_WID | NUMBER | Numeric identifier of the shipment. |
\n KIT_DESIGN_ID | RAW(16 BYTE) | GUID of the kit design. |
\n KIT_DESIGN_WID | NUMBER(10) | Numeric identifier of the kit design. |
\n INVENTORY_ID | RAW(16 BYTE) | GUID of the inventory record. |
\n INVENTORY_WID | NUMBER(10) | Numeric identifier of the inventory record. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"UnblindedKitsDataSetReport":{
"description":"UnblindedKitsDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"COMPOUNDING_KITS"
],
"data":[
[
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"Study01",
"Study01",
"STUDY01",
"Vaccines",
"IV",
"Observational",
"US",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"Tester2",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"US",
"Kansas",
"560068",
"1234567891",
"343",
"test@abc.com",
"Active",
"1.0.0.3",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"DATAHUB_AUT_Site2_Active",
"Site",
"FE1B887ADDDD4E6588075E5F8D4F0F1B",
"13",
"DATAHUB_AUT_Site2_Active13",
"DATAHUB_AUT_Site2_Screen13",
"Complete",
"DATAHUB_AUT_Site2_Active13",
"BasicRand_01",
"BasicRand_01_Description",
"Blinded",
"5F7C3E2A9B1D4F1E8A7C6B5A4D3E2F10",
"301",
"Default Cohort",
"1",
"C6BC3AF48A8F44EA9AEE157709CB5D39",
"19",
"Treatment_Arm_2",
"Treatment_Arm_2_description",
"TREATMENT_ARM_2_SHORTNAME",
"0",
"0",
"1",
"Assigned",
"2025-10-29T17:31:09.030Z",
"MLOT1",
"BLT1",
"MLOT1",
"BLT1",
"2030-12-31T00:00:00.000Z",
"2026-12-31T00:00:00.000Z",
"10",
"0",
"10",
"0",
"9A8B7C6D5E4F4A1B8C7D6E5F4A3B2C1D",
"1001",
"SHIP-0002",
"RECEIVED",
"2025-10-28T08:00:00.000Z",
"2025-10-28T10:00:00.000Z",
"TRK123999",
"1",
"Y",
"Week2",
"WEEK2",
"COMPLETE",
"2025-10-29T00:00:00.000Z",
"DISPENSATION",
"Visit_Complete",
"2025-11-24T00:00:00.000Z",
"2025-11-28T00:00:00.000Z",
"2025-11-26T00:00:00.000Z",
"28",
"0",
"2",
"0",
"2",
"0",
"449CBE4790CF4F66AB58619C86CA405B",
"206",
"Week3",
"WEEK3",
"Week3",
"1536",
"Device",
"ActivityWatch",
"DevicetoCloud",
"0",
"UNBLINDED",
"D26E345F8CBD44B6A22C666F11D1F04D",
"27",
"Device",
"DEVICE",
"1",
"1",
"0",
"N/A",
"0",
"0",
"0",
"424CA68C1E523E82E063BDD14C646211",
"255",
"50254",
"mHC2CDevice",
"Dispensed",
"2025-10-29T17:31:19.625Z",
"0",
"AW-50254",
"0",
"N/A",
"Once Daily",
"0",
"0",
"false",
"1",
"1",
"7E6D5C4B3A29100FEE12DDCCBBAA9988",
"0",
"Dose by Weight",
"Weight (kg)",
"Week1",
"2",
"0",
"Once Daily",
"0",
"0",
"70",
"2025-10-29T17:31:19.861Z",
"3099-12-31T00:00:00.000Z",
"MODIFIED",
"4",
"Data correction",
"Updated during data sync",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"Y",
"11223344556677889900AABBCCDDEEFF",
"88",
"Site Pharmacist",
"2025-10-29T12:15:00.000Z",
"A1B2C3D4E5F60718293A4B5C6D7E8F90",
"88",
"Site Pharmacist",
"2025-10-29T12:20:00.000Z",
"2",
"2025-10-29T17:32:35.284Z",
"BLK-0001",
"50262",
"MAT-001",
"ITEM-001",
"1",
"N",
"Outbound",
"N",
"CD1D3E9BB0C045EC8E55B2FE2E7242C0",
"14",
"Site User (template)",
"N"
]
]
}
},
"UnblindedKitsDataSetEmptyReport":{
"description":"UnblindedKitsDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"STUDY_ID",
"STUDY_WID",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"THERAPEUTIC_AREA",
"STUDY_PHASE",
"BLINDING_TYPE",
"COUNTRY_NAME",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"INVESTIGATOR",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_COUNTRY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STATUS",
"SITE_STUDY_VERSION",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"SITE_ID_NAME",
"SITE_TYPE",
"SUBJECT_ID",
"SUBJECT_WID",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"SUBJECT_STATE",
"SCREENING_NUMBER",
"RANDOMIZATION_TITLE",
"RANDOMIZATION_DESCRIPTION",
"RANDOMIZATION_TYPE",
"COHORT_ID",
"COHORT_WID",
"COHORT_NAME",
"RERANDOMIZATION",
"TREATMENT_ID",
"TREATMENT_WID",
"TREATMENT_ARM_TITLE",
"TREATMENT_ARM_DESCRIPTION",
"TREATMENT_ARM_ID",
"RESTRICT_RANDOMIZATION_TO_AVAILABLE_KIT_TYPES",
"ASSIGNED_SKIPPED_RANDOMIZATION_NUMBERS",
"RAND_NUMBER",
"RND_STATUS",
"RANDOMIZATION_DATE",
"MANFACTURING_LOT_TITLE",
"BLINDED_LOT_TITLE",
"MANFACTURING_LOT_SHORT_NAME",
"BLINDED_LOT_SHORT_NAME",
"MANFACTURING_LOT_EXPIRATION_DATE",
"BLINDED_LOT_EXPIRATION_DATE",
"MANFACTURING_LOT_DO_NOT_SHIP_DAYS",
"BLINDED_LOT_DO_NOT_SHIP_DAYS",
"MANFACTURING_LOT_DO_NOT_COUNT_DAYS",
"BLINDED_LOT_DO_NOT_COUNT_DAYS",
"SHIPMENT_ID",
"SHIPMENT_WID",
"SHIPMENT_NAME",
"SHIPMENT_STATUS",
"SHIPMENT_CREATED_DATE",
"SHIPMENT_DATE",
"TRACKING_NUMBER",
"VISIT_IS_REQUIRED",
"IS_SCHEDULED_VISIT",
"SCHEDULED_FROM_EVENT_NAME",
"SCHEDULED_FROM_EVENT_REFNAME",
"VISIT_STATUS",
"VISIT_START_DATE",
"VISIT_TYPE",
"EVENT_TYPE",
"PROJECTED_VISIT_START_DATE",
"PROJECTED_VISIT_END_DATE",
"PROJECTED_VISIT_DATE",
"DELAY_DAYS",
"DELAY_HOURS",
"VISIT_WINDOW_BEFORE_DAYS",
"VISIT_WINDOW_BEFORE_HOURS",
"VISIT_WINDOW_AFTER_DAYS",
"VISIT_WINDOW_AFTER_HOURS",
"EVENT_ID",
"EVENT_WID",
"EVENT_TITLE",
"EVENT_REFNAME",
"EVENT_ID_NAME",
"VISIT_ORDER",
"KIT_TYPE",
"DEVICE_TYPE",
"DEVICE_CONNECTION",
"CALCULATING_DOSES",
"DISTRIBUTION_SETTINGS",
"KIT_DESIGN_ID",
"KIT_DESIGN_WID",
"KIT_TYPE_ID",
"TRIAL_SUPPLY_TYPE",
"MINIMUM_KITS_TO_SHIP",
"UNITS_PER_KIT",
"SINGLE_UNIT_DOSE_VALUE",
"SINGLE_UNIT_DOSE_UNITS",
"CRA_VERIFIED",
"BALANCE_UNITS",
"TITRATION",
"INVENTORY_ID",
"INVENTORY_WID",
"SEQUENCE_NUMBER",
"KIT_DESCRIPTION",
"KIT_STATUS",
"DISPENSATION_DATE",
"DOSAGE",
"BAR_CODE",
"DISPENSATION_CONFIRMED",
"MEASUREMENT",
"FREQUENCY",
"RETURNED_UNITS",
"MISSING_UNITS",
"CONSERVED",
"QUANTITY",
"INSTANCE_NUMBER",
"CALCULATED_DOSE_ID",
"CALCULATED_DOSE_WID",
"CALCULATED_DOSE_TITLE",
"FORM_QUESTION_FOR_CALCULATED_DOSE",
"VISIT_WHERE_FORM_IS_COLLECTED",
"DOSE_PRECISION",
"DOSE_ROUND_UP",
"DOSE_FREQUENCY",
"DOSE_LEFT_OVER_UNITS",
"KIT_MEASUREMENT",
"SUBJECT_MEASUREMENT",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"OBJECT_VERSION_NUMBER",
"REASON",
"COMMENT",
"USER_ID",
"USER_WID",
"USER_NAME",
"IS_CURRENT",
"VERIFIED_BY_ID",
"VERIFIED_BY_WID",
"VERIFIED_BY",
"VERIFIED_DATE",
"CONFIRMED_BY_ID",
"CONFIRMED_BY_WID",
"CONFIRMED_BY",
"CONFIRMED_DATE",
"SOFTWARE_VERSION_NUMBER",
"DH_TIMESTAMP",
"BLOCK_NUMBER",
"KIT_NUMBER",
"MATERIAL_ID",
"ITEM_NUMBER",
"COUNT_OF_KITS",
"IS_NON_SERIALIZED_KIT",
"ORDER_TYPE",
"FORCED_RAND",
"CURRENT_STUDY_ROLE_ID",
"CURRENT_STUDY_ROLE_WID",
"CURRENT_STUDY_ROLE_NAME",
"COMPOUNDING_KITS"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"x-internal-id":"ec-datahub-svc-rest-v9.0-tenant-{tenantId}-studies-{studyId}-{mode}-unblindedKits-post",
"x-filename-id":"ec-datahub-svc-rest-v9.0-tenant-tenantid-studies-studyid-mode-unblindedkits-post"
}
},
"/ec-datahub-svc/rest/v3.1/tenant/{tenantId}/studies/{studyId}/{mode}/subjects":{
"post":{
"tags":[
"Data Hub/Datasets/Get subject data details"
],
"summary":"[Deprecated]: V3.1",
"description":"Deprecated: Use latest version instead.
Retrieves the study-permissioned Subject dataset for a single study and mode.
The dataset exposes versioned subject profile and status history, including identifiers and numbering, site assignment and transfer context, screening and enrollment outcomes, consent and demographic fields, and audit columns.
Supports select, filter, sort, limit, and offset query patterns.
The dataset returns subject-level history rows for subjects associated with the study and mode.
This version additionally includes the following data points: PREVIOUS_SUBJECT_NUMBER, FREEZE, VERIFIED, SIGNED, and EXTERNAL_SOURCE_STATUS_DATE.
Required permission: SubjectDatasetPost.
Recommended order columns: The backend query always orders results by DH_TIMESTAMP and VERSION_START in ascending order first. If orderColumns is empty, only these two columns are used. If orderColumns is provided, the specified columns are appended after DH_TIMESTAMP and VERSION_START. For stable, deterministic pagination, use STUDY_ID and SUBJECT_ID in the orderColumns field of the request payload.
",
"operationId":"retrieveSubjectDataSetQuery_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Execution mode for the study.
\nAllowed values: test, active, training.
\nExample: test.
\n",
"required":true,
"schema":{
"type":"string",
"example":"active",
"enum":[
"test",
"active",
"training"
]
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied in the studyId path parameter.
\nUse the uppercase hexadecimal UUID value for the study.
\nExample: 0C7CBA3F70034C47947E2FAB086BFBF5.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
}
},
{
"name":"tenantId",
"in":"path",
"description":"Unique tenant identifier supplied in the tenantId path parameter.
\nUse the uppercase hexadecimal UUID value for the tenant.
\nExample: EC942244BB30163BE053BEC44C64CF34.
\n",
"required":true,
"schema":{
"type":"string",
"format":"uuid",
"example":"EC942244BB30163BE053BEC44C64CF34"
}
},
{
"name":"limit",
"in":"query",
"description":"Page size for the result set.
\n\n 0 disables pagination and returns the maximum result set allowed by the dataset endpoint.- Positive values enable pagination.
\n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"offset",
"in":"query",
"description":"Zero-based row offset.
\n\n - Counts rows, not pages.
\n - To fetch the next page, repeat the same request body and set
offset = previous offset + previous count. \n - When
limit = 0, this value is ignored and the response echoes offset = 0. \n - When
limit > 0, an offset beyond the available rows returns HTTP 200 with an empty page. \n - Negative values return HTTP 400.
\n
\n",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubQueryDto"
},
"examples":{
"SubjectDataSetQuery":{
"description":"SubjectDataSetQuery",
"value":{
"selectColumns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"whereColumns":[
{
"columnName":"DH_TIMESTAMP",
"operator":">=",
"value":[
"2026-04-08T00:00:00.000Z"
]
},
{
"columnName":"DH_TIMESTAMP",
"operator":"<=",
"value":[
"2026-04-09T00:00:00.000Z"
]
}
],
"orderColumns":[
{
"columnName":"STUDY_ID",
"sortOrder":"ASC"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Response behavior
\n\n - The response is tabular.
columns defines the selected output order, and each row in data follows that same order. \n - Every value in
data is returned as a JSON string or null, including logical numbers and date/time values. \n hasMore = \"true\" means more matching rows exist after the current page.- If filters match no rows, or
offset is beyond the last row, the API returns HTTP 200 with data = [], count = 0, and hasMore = \"false\". \n
\n\nSection index
\nStudy context | Site context | Country context | Subject context | Event context | Aggregation metrics | Audit context | Reference and system identifiers
\n\nStudy context
\nStudy-level identifiers, version metadata, and protocol attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_TITLE | VARCHAR2(4000 CHAR) | The STUDY_TITLE data element reflects the title of a protocol as defined by the study manager each time a new study version is created and renamed in the Study Mode section. For example, if the original study version is named P01_A23 in Active mode, that name appears as the STUDY_TITLE. If the study manager later creates a new version of the study and renames it to P01_A23_Production2, this new name will be displayed as the STUDY_TITLE for that version when used in Active mode. When you include multiple study versions in your dataset, and each has a different title, the STUDY_TITLE element will reflect the specific title assigned to each version. For example, your dataset might include study versions 1.0.2, 1.0.3, and 1.0.4. If the study manager renamed each version, you would see those unique titles in the dataset: P_01_A23 (for study version 1.0.2)P01_A23_Production2 (for study version 1.0.3)P01_A23_Production3 (for study version 1.0.4)
|
\n STUDY_ID_NAME | VARCHAR2(64 CHAR) | A study ID as specified by the study manager when they created the study, such as a protocol acronym and protocol number. |
\n STUDY_REFNAME | VARCHAR2(64 CHAR) | Indicates the study's reference name used by the system. This value is composed by the STUDY_ID_NAME converted to uppercase with blank spaces removed. Once created, this value never changes, even if STUDY_ID_NAME is changed. |
\n STUDY_VERSION | VARCHAR2(32 CHAR) | Indicates the study version number of the referencing data in a custom report. |
\n STUDY_SERIAL_NUMBER | NUMBER | For internal use only. Internal Clinical One study identifier. |
\n STUDY_PHASE | VARCHAR2(64 CHAR) | A study's phase as indicated by the study manager when they created the study. Possible values include I, I/II, II, II/III, III, IV, or Other. |
\n BLINDING_TYPE | VARCHAR2(64 CHAR) | Indicates whether the study is an open-label type of study or a blinded study, as specified by the study manager when they created the study. Possible values include OpenLabel, Blinded, OpenLabelBlinded, or Observational. |
\n THERAPEUTIC_AREA | VARCHAR2(64 CHAR) | Indicates the therapeutic area as specified by the study manager when they created the study. Possible values include CardiologyVascularDiseases, DentalOralHealth, Dermatology, Endocrinology, FamilyMedicine, Gastroenterology, GeneticDisease, HealthyVolunteers, Hematology, Hepatology, Immunology, InfectionsInfectiousDisease, Musculoskeletal, Nephrology, Neurology, NutritionWeightLoss, ObstetricsGynecology, Oncology, Ophthalmology, Otolaryngology, PediatricsNeonatology, PlasticSurgery, PharmacologyToxicology, Podiatry, PsychiatryPsychology, PulmonaryRespiratoryDiseases, Rheumatology, Sleep, Trauma, Urology, or Vaccines. |
\n\n
\n\nParent topic: Section index
\n
\n\nSite context
\nSite profile, operational settings, and site-maintained contact details associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SITE_NAME | VARCHAR2(500 CHAR) | Indicates the site's name as entered by a site manager when they created or last modified a site. |
\n SITE_ID_NAME | VARCHAR2(50 CHAR) | Indicates the site ID as entered by a site manager when they created or last modified a site. |
\n SITE_STATUS | VARCHAR2(50 CHAR) | Indicates the status of a site whether it is New, Active, or Retired. |
\n SITE_STUDY_VERSION | VARCHAR2(2048 CHAR) | The study version assigned to the site, as configured by a site manager. |
\n SITE_SERIAL_NUMBER | NUMBER | The serial number of the site |
\n FROM_SITE_NAME | VARCHAR2(500 CHAR) | If a subject is transferred, this field is populated with the site the subject was transferred from |
\n INVESTIGATOR | VARCHAR2(2048 CHAR) | A Principal Investigator's Full Name as listed when the site manager created the site. |
\n PI_PREFIX | VARCHAR2(2048 CHAR) | The principal investigator's prefix at the site. Possible values include 1st Lt, Adm, Atty, Brother, Capt, Chief, Cmdr, Col, Dean, Dr, Elder, Father, Gen, Gov, Hon, Lt Col, Maj, MSgt, Mr, Mrs, Ms, Prince, Prof, Rabbi, Rev, or Sister. |
\n DEA_NUMBER | VARCHAR2(2048 CHAR) | The DEA registration number. |
\n EXPIRATION | VARCHAR2(2048 CHAR) | Indicates the expiration date of the DEA Registration Number as defined by a site manager. |
\n ADD_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from adding subjects at one or multiple sites. Possible values include true or false. |
\n SCREEN_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from screening subjects at one or multiple sites. Possible values include true or false. |
\n RANDOMIZE_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from randomizing subjects at one or multiple sites. Possible values include true or false. |
\n DISPENSE_TO_SUBJECTS | VARCHAR2(2048 CHAR) | Flag that enables or prevents site users from dispensing kits, devices or performing dose changes for subjects at one or multiple sites. Possible values include true or false. |
\n DRUG_DESTRUCTION_CAPABLE | VARCHAR2(2048 CHAR) | Flag that defines if the kit type is destructible at the site. Possible values include true or false. |
\n SDV_GROUP_NAME | VARCHAR2(255) | Name of the SDV Strategy, as entered by the study manager. |
\n INITIAL_SUBJECTS_COUNT | VARCHAR2(2048) | Number of initial subjects included in the SDV strategy. |
\n INITIAL_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n REMAINING_SUBJECTS_PERCENTAGE | VARCHAR2(2048) | Number of remaining subjects included in the SDV strategy. |
\n REMAINING_SUBJECTS_SDV_TYPE | VARCHAR2(2048) | Type of Source Data Verification: All Questions or Critical Questions. Possible values include All Questions or Critical Questions Only. |
\n ADDRESS_STREET_1 | VARCHAR2(150 CHAR) | A site's first address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STREET_2 | VARCHAR2(150 CHAR) | A site's second address as entered by the site manager when they created or last modified the site. |
\n ADDRESS_CITY | VARCHAR2(100 CHAR) | A site's city as entered by the site manager when they created or last modified the site. |
\n ADDRESS_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | A site's state, province, or county as entered by the site manager when they created or last modified the site. |
\n ADDRESS_POSTALCODE | VARCHAR2(20 CHAR) | The Zip Postal Code associated with a site's address. |
\n ADDRESS_COUNTRY | VARCHAR2(4000 CHAR) | A site's country as entered by the site manager when they created or last modified the site. The field display the country ISO code. |
\n PHONE | VARCHAR2(500 CHAR) | The contact phone number as entered by the site manager when they created or last modified the site. |
\n FAX | VARCHAR2(500 CHAR) | The contact fax number as entered by the site administrator when they created or last modified the site. |
\n EMAIL | VARCHAR2(500 CHAR) | Email address of the site as entered by the site administrator when they created or last modified the site. |
\n TIMEZONE | VARCHAR2(2048 CHAR) | Indicates the time zone the site is currently placed on as specified by a site manager. |
\n SHIPPING_ATTENTION | VARCHAR2(2048 CHAR) | Indicates the name of the person who will receive shipments at the site, as specified by a site manager. |
\n SHIPPING_ADDRESS_1 | VARCHAR2(150 CHAR) | The first line of a site's shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ADDRESS_2 | VARCHAR2(150 CHAR) | The second line of a site's second shipping address as entered by the site manager when they created or last modified the site. |
\n SHIPPING_CITY | VARCHAR2(100 CHAR) | City associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_STATE_OR_PROV_OR_CNTY | VARCHAR2(100 CHAR) | State, province, or county associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_ZIP | VARCHAR2(20 CHAR) | Zip Postal Code associated with the shipping address. |
\n SHIPPING_COUNTRY | VARCHAR2(4000 CHAR) | Country associated with the shipping address, as entered by the site manager when they created or last modified the site. |
\n SHIPPING_PHONE | VARCHAR2(500 CHAR) | Phone number associated with the shipping address. |
\n SHIPPING_FAX | VARCHAR2(500 CHAR) | Fax number associated with the shipping address. |
\n SHIPPING_EMAIL | VARCHAR2(500 CHAR) | Email address associated with the shipping address. |
\n\n
\n\nParent topic: Section index
\n
\n\nCountry context
\nCountry-level fields exposed separately in Oracle Analytics for geographic reporting.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n COUNTRY_NAME | VARCHAR2(4000 CHAR) | Indicates a country's two-digit ISO code. |
\n\n
\n\nParent topic: Section index
\n
\n\nSubject context
\nSubject identity, status, enrollment, and transfer attributes associated with the record.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n SUBJECT_NUMBER | VARCHAR2(500 CHAR) | The number currently assigned to the subject in the system as identifier. Note: NULL is displayed if a subject was removed using the Undo Add Subject feature. |
\n PREVIOUS_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | When a subject number change is applied, this field holds the number that was assigned to the subject before the change. |
\n OLD_SUBJECT_NUMBER | VARCHAR2(500 CHAR) | A subject's previously assigned number in the system for a transferred subject. |
\n DOB | DATE | Indicates the date of birth. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n GENDER | VARCHAR2(10 CHAR) | The selected gender a subject identifies as. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n STATE | VARCHAR2(100 CHAR) | A subject's state in Clinical One Cloud Service. Note: When a subject is Screened, the dataset returns Screening_Initiated until the next visit is complete and the subject becomes Active. When a subject is Screen Failed, the dataset returns Auto_Screen_Failed. Possible values include New, Screening_Initiated, Screen_Failed, Auto_Screen_Failed, Enrolled, Active, Subject Visit, Subject_Transferred, Withdrawn, or Complete. |
\n STATE_DATE | DATE | The date the subject entered a state. |
\n SCREENING_DATE | DATE | Date of the subject's initial screening visit. |
\n INFORMED_CONSENT_DATE | DATE | The date on which the informed consent was signed by the subject. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n SCREENING_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject failed the screening. Possible values include Y or N. |
\n ENROLLMENT_FAILURE | VARCHAR2(255 CHAR) | Indicates whether a subject could not be enrolled in the study. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n ENROLLMENT_OVERRIDE | VARCHAR2(255 CHAR) | Indicates a subject's enrollment override. Currently, this is a placeholder column that does not contain any data. This column is planned for a future release. |
\n EXTERNAL_SOURCE_STATUS_DATE | TIMESTAMP(6) | Indicates the date on which the subject status was updated by an external source. |
\n CODE_BREAK | VARCHAR2(2 CHAR) | Indicates whether a subject went through a Code Break event. Possible values include Y or N. |
\n\n
\n\nParent topic: Section index
\n
\n\nEvent context
\nEvent metadata, visit scheduling, and visit-status attributes associated with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n EVENT_TYPE | VARCHAR2(100) | Displays the type of event that impacts a subject's status. Only events that occurred in the study are displayed. Possible subject event values include: NewScreenedRandomizedWithdrawnUndo_WithdrawnTransferredScreen_FailedScreen_Fail_UpdateCode_BreakCompleteUndo_CompleteUndo_ScrFailedEnrolledUndo_Add_SubjectSubjectNumberChangedSubjectNumberReplacedSubjectPatientLinkCreatedSubjectPatientLinkRemovedCompletionUpdateWithdrawalUpdateUndo_EnrolledScreenUpdateEnrollUpdate
|
\n\n
\n\nParent topic: Section index
\n
\n\nAggregation metrics
\nDerived counts and rollup indicators calculated from the underlying study data.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n TOTAL_VISITS | NUMBER | The total number of visits in a study version. This count does not include unscheduled visits. |
\n COMPLETED_VISITS | NUMBER | Count of completed visits for a subject. When there are incomplete visits, the count is recalculated. This data element does not include unscheduled visits. |
\n TOTAL_FORMS | NUMBER | The total number of forms across visits in the study version. - A repeating form instance is counted as one form.
- Forms assigned to an unscheduled visit are not included in this count.
|
\n COMPLETED_FORMS | NUMBER | Count of completed forms for a subject, irrespective of visit status and form status. Each instance of a repeating form is counted as one form. |
\n TOTAL_FORMS_COMPLETED_VISITS | NUMBER | The total number of completed forms associated with visits. |
\n FREEZE | VARCHAR2(16 CHAR) | Indicates if the subject's data is frozen by a data manager or CRA. Possible values include FROZEN or UNFROZEN. |
\n VERIFIED | VARCHAR2(16 CHAR) | Indicates the aggregate verification status for the subject's data. Data element can be populated with the following values: VERIFIED: A question, form, or visit is verified.UNVERIFIED: A question, form, or visit was once verified, then updated making it unverified.VERIFY_REQUIRED: A question, form, or visit requires verification and is not yet verified.
|
\n SIGNED | VARCHAR2(16 CHAR) | Indicates if a valid casebook signature is applied to the subject. Possible values include SIGNED or UNSIGNED. |
\n\n
\n\nParent topic: Section index
\n
\n\nAudit context
\nAudit-trail metadata describing row versioning, acting users, and reason-for-change details.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n VERSION_START | TIMESTAMP(6) | Audit trail timestamp when this version of the dataset row became effective. Together with VERSION_END, it defines the validity window for the row version. |
\n VERSION_END | TIMESTAMP(6) | Indicates the date and time of when data was changed, if the data is not current. |
\n OPERATION_TYPE | VARCHAR2(16 CHAR) | Audit trail field that indicates how the dataset row version was produced. CREATED: the row was initially created.MODIFIED: an existing row was updated.REMOVED: the row was removed from the active record set.
|
\n USER_NAME | VARCHAR2(255 CHAR) | Audit trail field that represents the user who performed the action. The value for this column may represent a user's actual username or a user's email address, depending on how the user login was defined in Oracle Life Sciences IAMS. |
\n OBJECT_VERSION_NUMBER | NUMBER | Audit trail field that represents the version number of the data. |
\n REASON | VARCHAR2(255 CHAR) | Audit trail reason recorded for the dataset row change. Populated when a reason for change is provided for the row update. |
\n COMMENT | VARCHAR2(2048 CHAR) | Required comment in a reason for change if Other is selected. Populated as Rule Execution for calculated values. |
\n IS_CURRENT | CHAR(1) | Audit trail flag that indicates whether the dataset row version is the current version (Y) or a historical version (N). |
\n \n
\n\nParent topic: Section index
\n
\n\nReference and system identifiers
\nSystem identifiers, numeric reference keys, and technical linkage fields carried with the dataset row.
\n\n \n \n | Column Name | \n Data Type | \n Description | \n
\n \n \n STUDY_ID | RAW(16 BYTE) | GUID of the study. |
\n STUDY_WID | NUMBER(10) | A number that represents the unique identifier of the study. |
\n SITE_ID | RAW(16 BYTE) | GUID of the site. |
\n SITE_WID | NUMBER(10) | A number that represents the unique identifier of a site. |
\n USER_ID | RAW(16 BYTE) | GUID of the user. |
\n USER_WID | NUMBER(10) | Indicates a user's numeric identifier. |
\n FROM_SITE_ID | RAW(16 BYTE) | GUID of the site from which the subject was transferred. |
\n FROM_SITE_WID | NUMBER(10) | Indicates the site numeric identifier from which the subject was transferred. |
\n ID | RAW(16 BYTE) | Row-level GUID that uniquely identifies this Subject dataset record. |
\n SUBJECT_WID | NUMBER(10) | A number that represents the unique identifier of the subject. |
\n SUBJECT_TRANSFER_ID | RAW(16 BYTE) | GUID of the subject transfer record. |
\n DESCRIPTION | VARCHAR2(500 CHAR) | This is a placeholder column that does not contain any data. |
\n DH_TIMESTAMP | TIMESTAMP(6) | A timestamp that indicates when the data became available in the dataset. |
\n SOFTWARE_VERSION_NUMBER | NUMBER | A number that increases incrementally every time a data point is modified. |
\n \n
\n\nParent topic: Section index
\n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubReportDto"
},
"examples":{
"SubjectDataSetReport":{
"description":"SubjectDataSetReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":1,
"limit":1,
"offset":0,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
[
"C6A18791060849BBBAE1F7A16A62B389",
"1",
"Auto-created subject for Site2",
"DATAHUB_AUT_Site2_Active01",
"DATAHUB_AUT_Site2_Screen01",
"0C7CBA3F70034C47947E2FAB086BFBF5",
"25",
"3042285B08804CFF98F8F96B3626C843",
"455",
"DATAHUB_AUT_Site2_Active",
"1988-07-12T00:00:00.000Z",
"2025-10-20T09:15:00.000Z",
"New",
"2025-10-29T13:06:18.000Z",
"N",
"None",
"None",
"2025-10-20T09:20:00.000Z",
"Female",
"6A1D5B3E2C0B4D8E9F1A2C3B4D5E6F70",
"1.0.0.2",
"N",
"New",
"1",
"25",
"United States",
"Tester2",
"2025-10-29T13:06:18.477Z",
"2025-10-29T13:31:11.301Z",
"CREATED",
"33D0D74837F6454B836AAB5BA2574D30",
"46",
"testuser1",
"1",
"7",
"Initial subject creation",
"Created via data hub load",
"N",
"2025-10-29T13:33:21.638Z",
"11",
"27",
"1",
"1",
"6",
"N",
"N",
"N",
"2025-10-29T13:00:00.000Z",
"Study01",
"Study01",
"STUDY01",
"IV",
"Vaccines",
"Observational",
"5B2F3C4D6E7F4890A1B2C3D4E5F60718",
"452",
"DATAHUB_AUT_Site1",
"DATAHUB_AUT_Site1_Active05",
"DATAHUB_AUT_Site2_Active",
"Active",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"456abc",
"Suite 12",
"Boston",
"Kansas",
"560068",
"US",
"1234567891",
"343",
"test@abc.com",
"1.0.0.3",
"false",
"Dr.",
"true",
"true",
"true",
"true",
"AB1234567",
"2027-12-31",
"Asia/Kolkata",
"Receiving Dept",
"100% SDV",
"10",
"Targeted",
"50",
"Reduced"
]
]
}
},
"SubjectDataSetEmptyReport":{
"description":"SubjectDataSetEmptyReport",
"value":{
"hasMore":"false",
"totalResults":1,
"count":0,
"limit":1,
"offset":1,
"columns":[
"ID",
"SUBJECT_WID",
"DESCRIPTION",
"SUBJECT_NUMBER",
"PREVIOUS_SUBJECT_NUMBER",
"STUDY_ID",
"STUDY_WID",
"SITE_ID",
"SITE_WID",
"SITE_NAME",
"DOB",
"SCREENING_DATE",
"STATE",
"STATE_DATE",
"SCREENING_FAILURE",
"ENROLLMENT_FAILURE",
"ENROLLMENT_OVERRIDE",
"INFORMED_CONSENT_DATE",
"GENDER",
"SUBJECT_TRANSFER_ID",
"STUDY_VERSION",
"CODE_BREAK",
"EVENT_TYPE",
"SITE_SERIAL_NUMBER",
"STUDY_SERIAL_NUMBER",
"COUNTRY_NAME",
"INVESTIGATOR",
"VERSION_START",
"VERSION_END",
"OPERATION_TYPE",
"USER_ID",
"USER_WID",
"USER_NAME",
"OBJECT_VERSION_NUMBER",
"SOFTWARE_VERSION_NUMBER",
"REASON",
"COMMENT",
"IS_CURRENT",
"DH_TIMESTAMP",
"TOTAL_VISITS",
"TOTAL_FORMS",
"COMPLETED_VISITS",
"TOTAL_FORMS_COMPLETED_VISITS",
"COMPLETED_FORMS",
"FREEZE",
"VERIFIED",
"SIGNED",
"EXTERNAL_SOURCE_STATUS_DATE",
"STUDY_ID_NAME",
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_PHASE",
"THERAPEUTIC_AREA",
"BLINDING_TYPE",
"FROM_SITE_ID",
"FROM_SITE_WID",
"FROM_SITE_NAME",
"OLD_SUBJECT_NUMBER",
"SITE_ID_NAME",
"SITE_STATUS",
"ADDRESS_STREET_1",
"ADDRESS_STREET_2",
"ADDRESS_CITY",
"ADDRESS_STATE_OR_PROV_OR_CNTY",
"ADDRESS_POSTALCODE",
"ADDRESS_COUNTRY",
"PHONE",
"FAX",
"EMAIL",
"SHIPPING_ADDRESS_1",
"SHIPPING_ADDRESS_2",
"SHIPPING_CITY",
"SHIPPING_STATE_OR_PROV_OR_CNTY",
"SHIPPING_ZIP",
"SHIPPING_COUNTRY",
"SHIPPING_PHONE",
"SHIPPING_FAX",
"SHIPPING_EMAIL",
"SITE_STUDY_VERSION",
"DRUG_DESTRUCTION_CAPABLE",
"PI_PREFIX",
"ADD_SUBJECTS",
"SCREEN_SUBJECTS",
"RANDOMIZE_SUBJECTS",
"DISPENSE_TO_SUBJECTS",
"DEA_NUMBER",
"EXPIRATION",
"TIMEZONE",
"SHIPPING_ATTENTION",
"SDV_GROUP_NAME",
"INITIAL_SUBJECTS_COUNT",
"INITIAL_SUBJECTS_SDV_TYPE",
"REMAINING_SUBJECTS_PERCENTAGE",
"REMAINING_SUBJECTS_SDV_TYPE"
],
"data":[
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request is invalid.
\n\n - Causes include invalid
tenantId or studyId, negative limit or offset, empty selectColumns, invalid dataset columns, invalid whereColumns operator/value combinations, duplicate orderColumns, invalid sortOrder, and malformed typed filter values. \n - Error payload format:
{\"status\":\"failed\",\"result\":null,\"errorData\":{\"errorCode\":\"...\",\"errorMessage\":\"...\",\"details\":{...}},\"version\":1}. \n
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DataHubResponse"
},
"examples":{
"InvalidSelectColumn":{
"description":"InvalidSelectColumn",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: STUDY_ID1"
},
"version":1
}
},
"NegativePagination":{
"description":"NegativePagination",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"limit and offset cannot be negetive"
},
"version":1
}
},
"InvalidWhereOperator":{
"description":"InvalidWhereOperator",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid operator in where clause: CONTAINS for the column: STUDY_ID"
},
"version":1
}
},
"InvalidIsOperatorValue":{
"description":"InvalidIsOperatorValue",
"value":{
"status":"failed",
"result":null,
"errorData":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Only NULL is allowed with IS / IS NOT operator"
},
"version":1
}
}
}
}
}
},
"401":{
"description":"Returned when the request cannot be authenticated.
\nThe response body is empty.
\n"
},
"403":{
"description":"Returned when the request is authenticated but the caller is not authorized to access the requested resource.
\nThe response body contains a plain-text authorization message.
\nPossible response bodies:
\n\n Either the resource does not exist, or the user cannot access the resource.The entity is in maintenance mode, or the user cannot access the resource.
\n",
"content":{
"text/plain":{
"schema":{
"type":"string"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":"Either the resource does not exist, or the user cannot access the resource.\n"
},
"ForbiddenMaintenance":{
"description":"ForbiddenMaintenance",
"value":"The entity is in maintenance mode, or the user cannot access the resource.\n"
}
}
}
}
},
"500":{
"description":"Returned when an unexpected server-side error occurs while processing the request.
\nThe response body contains the platform error payload with the error code and description.
\n",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Status"
},
"examples":{
"InternalServerError":{
"description":"InternalServerError",
"value":{
"description":"An internal error has occurred, please check the log for details.",
"code":"Internal Server Error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-datahub-svc-rest-v3.1-tenant-{tenantId}-studies-{studyId}-{mode}-subjects-post",
"x-filename-id":"ec-datahub-svc-rest-v3.1-tenant-tenantid-studies-studyid-mode-subjects-post"
}
},
"/ec-fileupload-svc/rest/v3.0/storage/{bucketName}/{objectName}":{
"put":{
"tags":[
"File Upload/v3.0"
],
"summary":"Upload a file to the system",
"description":"Uploads a file in the context of bucket name.
Right: FileUploadFilePost.",
"operationId":"createObject",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"overwrite",
"in":"query",
"description":"Set to true if any existing file part has to be overwritten with the same name.",
"schema":{
"type":"boolean"
}
},
{
"name":"fileType",
"in":"query",
"description":"Reserved for future usage. Type of file indicating whether the file is a Site, Depot or Countries CSV.",
"schema":{
"type":"string"
}
},
{
"name":"serviceName",
"in":"query",
"description":"Reserved for future usage. Name of the service which uses the uploaded file.",
"schema":{
"type":"string"
}
},
{
"name":"notificationRequired",
"in":"query",
"description":"Reserved for future usage. Indicates whether notification needs to be sent to user or not. Allowed value is either true or false.",
"schema":{
"type":"boolean"
}
},
{
"name":"bucketName",
"in":"path",
"description":"Bucket Name. Tenant or study or user defined user name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"objectName",
"in":"path",
"description":"Name of the file to be uploaded.",
"required":true,
"schema":{
"type":"string"
}
}
],
"requestBody":{
"description":"Content to be uploaded, in binary form.",
"content":{
"*/*":{
"schema":{
"type":"object"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ObjectModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-{bucketName}-{objectName}-put",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-bucketname-objectname-put"
},
"delete":{
"tags":[
"File Upload/v3.0"
],
"summary":"Delete a file successfully uploaded before",
"description":"Deletes a file uploaded in the context of a bucket and object name.
Right: FileUploadFileDelete.",
"operationId":"deleteObject",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"bucketName",
"in":"path",
"description":"Tenant, study or user-defined name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"objectName",
"in":"path",
"description":"Name of the file to be deleted.",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"204":{
"description":"Success"
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-{bucketName}-{objectName}-delete",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-bucketname-objectname-delete"
}
},
"/ec-fileupload-svc/rest/v3.0/storage/{bucketName}/{objectName}/parts/{partNumber}":{
"put":{
"tags":[
"File Upload/v3.0"
],
"summary":"Upload a part of a file",
"description":"Uploads file parts, which are chunks from a large file. The bucket and file name must be same across all file parts.
Right: FileUploadFilePost. ",
"operationId":"uploadFilePart",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"overwrite",
"in":"query",
"description":"When it is set to true, it will overwrite the existing part file if exists.",
"schema":{
"type":"boolean"
}
},
{
"name":"bucketName",
"in":"path",
"description":"Bucket Name. Tenant or study or user defined user name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"objectName",
"in":"path",
"description":"Name of the file to be merged or deleted.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"partNumber",
"in":"path",
"description":"File part number.",
"required":true,
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"requestBody":{
"description":"Content of the file part, in binary form.",
"content":{
"*/*":{
"schema":{
"type":"object"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ObjectModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-{bucketName}-{objectName}-parts-{partNumber}-put",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-bucketname-objectname-parts-partnumber-put"
},
"delete":{
"tags":[
"File Upload/v3.0"
],
"summary":"Delete a file part",
"description":"Deletes a file part in the context of a bucket name.
Right: FileUploadFileDelete.",
"operationId":"deleteFilePart",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"bucketName",
"in":"path",
"description":"Bucket Name. Tenant or study or user defined user name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"objectName",
"in":"path",
"description":"Name of the file to be deleted.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"partNumber",
"in":"path",
"description":"File part number.",
"required":true,
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ObjectModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-{bucketName}-{objectName}-parts-{partNumber}-delete",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-bucketname-objectname-parts-partnumber-delete"
}
},
"/ec-fileupload-svc/rest/v3.0/storage/file/{objectName}":{
"get":{
"tags":[
"File Upload/v3.0"
],
"summary":"Download an uploaded file",
"description":"Downloads a file from a bucket. You can only download files uploaded into the system.
Right: FileUploadFileDownload.",
"operationId":"downloadObject",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"study",
"in":"query",
"description":"Tenant, study or user-defined name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"objectName",
"in":"path",
"description":"Tenant or name of the file to be downloaded.",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/octet-stream":{
"schema":{
"type":"string"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-file-{objectName}-get",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-file-objectname-get"
}
},
"/ec-fileupload-svc/rest/v3.0/storage/config":{
"get":{
"tags":[
"File Upload/v3.0"
],
"summary":"Get the admin configurations for file upload service",
"description":"Retrieves the admin configurations for file upload service in JSON format.
Right: FileUploadAdminConfig.",
"operationId":"getAdminConfig",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"study",
"in":"query",
"description":"Tenant, study or user-defined name.",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ConfigurationModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-config-get",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-config-get"
},
"put":{
"tags":[
"File Upload/v3.0"
],
"summary":"Update configuration in the system",
"description":"Updates the configuration in the system.
Right: FileUploadAdminConfig.",
"operationId":"updateConfiguration",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ConfigurationModel"
}
}
}
},
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ObjectModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-config-put",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-config-put"
}
},
"/ec-fileupload-svc/rest/v3.0/storage/list":{
"get":{
"tags":[
"File Upload/v3.0"
],
"summary":"Get a list of uploaded files",
"description":"Retrieves list of uploaded files where number of files retrieved is less than limit specified.
Right: FileUploadFileGet.",
"operationId":"getAllObjectsByUser",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"status",
"in":"query",
"description":"Status of files which needs to be retrieved. Allowed status are SUCCESS, INPROGRESS, FAILED, ALL. Default is SUCCESS.",
"schema":{
"type":"string"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"study",
"in":"query",
"description":"Tenant, study or user-defined name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"noOfDays",
"in":"query",
"description":"Specifies how many days old files should be retrieved from the current server time zone.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"Specifies the number of records to be retrieved per page. If limit is not specified, 50 records will be shown, if they exist.",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"byUser",
"in":"query",
"description":"Set to true to filter response based on current user. If no filter is provided, a list files of all user will be returned.",
"schema":{
"type":"string"
}
},
{
"name":"nextPageStartId",
"in":"query",
"description":"Next page start index to retrieve files list.",
"required":true,
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ObjectListModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-list-get",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-list-get"
}
},
"/ec-fileupload-svc/rest/v3.0/storage/file/metadata/{objectName}":{
"get":{
"tags":[
"File Upload/v3.0"
],
"summary":"Get metadata of an uploaded file",
"description":"Retrieves the metadata of an uploaded file.
Right: FileUploadFileGet.",
"operationId":"getFileObjectMetaData",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"study",
"in":"query",
"description":"Parent file name which can be a study name or any user-defined name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"objectName",
"in":"path",
"description":"Name of the file to be retrieved.",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ObjectModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-file-metadata-{objectName}-get",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-file-metadata-objectname-get"
}
},
"/ec-fileupload-svc/rest/v3.0/storage/{bucketName}/{objectName}/parts":{
"post":{
"tags":[
"File Upload/v3.0"
],
"summary":"Merge or delete file parts",
"description":"Merges or deletes existing file parts which are already uploaded in the context of the bucket name.
Right: FileUploadFilePost.",
"operationId":"manageFileParts",
"parameters":[
{
"name":"studyId",
"in":"query",
"description":"The ID of the study.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"mode",
"in":"query",
"description":"Mode of the study from which you are uploading the file. Allowed values are active, test and training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"overwrite",
"in":"query",
"description":"When it is set to true, it will overwrite the existing merged file with the same name, if any.",
"schema":{
"type":"boolean"
}
},
{
"name":"bucketName",
"in":"path",
"description":"Bucket Name. Tenant or study or user defined user name.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"objectName",
"in":"path",
"description":"Name of the file to be deleted.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"action",
"in":"query",
"description":"Action to be performed on the file. Accepts MERGE_PARTS and DELETE_PARTS. MERGE_PARTS merges existing parts for the file. DELETE_PARTS removes all parts for the file from the system.",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ObjectModel"
}
}
}
},
"500":{
"description":"Internal server error."
},
"401":{
"description":"Unauthorized user."
}
},
"x-internal-id":"ec-fileupload-svc-rest-v3.0-storage-{bucketName}-{objectName}-parts-post",
"x-filename-id":"ec-fileupload-svc-rest-v3.0-storage-bucketname-objectname-parts-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/lots/blinded-lots":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get blinded lots"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves list of blinded lots by study ID. Rights: LotManagementGet.",
"operationId":"getAllBlindedLots",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":50
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/BlindedLotsV2"
}
},
"examples":{
"Get All Blinded Lots Response":{
"description":"Get All Blinded Lots Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"blindedLotNumber":"Blot1001",
"shortName":"Blot1001",
"expirationDate":"2026-12-31T00:00:00Z",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB",
"0B8D7E696B6A4F3D8E544C5D2B7B8A91"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
]
}
]
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Blinded Lots Forbidden Response":{
"description":"Get All Blinded Lots Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"getAllBlindedLots",
"reason":"The caller does not have permission to view blinded lots."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Blinded Lots Server Error Response":{
"description":"Get All Blinded Lots Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while retrieving blinded lots.",
"details":{
"operation":"getAllBlindedLots",
"reason":"The blinded lot lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-blinded-lots-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-blinded-lots-get"
},
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create blinded lot"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Creates a blinded lot by study ID. Rights: LotManagementPost.",
"operationId":"createBlindedLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotRequest"
},
"examples":{
"Create Blinded Lot Request":{
"description":"Create Blinded Lot Request",
"value":{
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB",
"0B8D7E696B6A4F3D8E544C5D2B7B8A91"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotId"
},
"examples":{
"Create Blinded Lot Response":{
"description":"Create Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"400":{
"description":"Blinded lot number or lot short name already exists. OR Expiration date is not valid. OR Invalid lot. OR Lot belongs to a blinded lot.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinded Lot Bad Request Response":{
"description":"Create Blinded Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot request is invalid.",
"details":{
"field":"manufacturingLotIds",
"reason":"At least one valid manufacturing lot identifier must be supplied."
}
}
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinded Lot Forbidden Response":{
"description":"Create Blinded Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"createBlindedLot",
"reason":"The caller does not have permission to create blinded lots."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinded Lot Server Error Response":{
"description":"Create Blinded Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while creating the blinded lot.",
"details":{
"operation":"createBlindedLot",
"reason":"The blinded lot could not be created."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-blinded-lots-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-blinded-lots-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/lots/blinded-lots/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get blinded lot by ID"
],
"summary":"v1.0",
"description":"Retrieves blinded lot by a blinded lot's ID. Rights: LotManagementGet.",
"operationId":"getBlindedLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of blinded lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsV2"
},
"examples":{
"Get Blinded Lot Response":{
"description":"Get Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"blindedLotNumber":"Blot1001",
"shortName":"Blot1001",
"expirationDate":"2026-12-31T00:00:00Z",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB",
"0B8D7E696B6A4F3D8E544C5D2B7B8A91"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
]
}
}
}
}
}
},
"404":{
"description":"Blinded lot not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lot Not Found Response":{
"description":"Get Blinded Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinded lot was not found.",
"details":{
"field":"id",
"reason":"The supplied blinded lot identifier does not exist."
}
}
}
}
}
}
}
},
"403":{
"description":"User doesn't have access to the requested data.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lot Forbidden Response":{
"description":"Get Blinded Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"getBlindedLot",
"reason":"The caller does not have permission to view the blinded lot."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lot Server Error Response":{
"description":"Get Blinded Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while retrieving the blinded lot.",
"details":{
"operation":"getBlindedLot",
"reason":"The blinded lot lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-blinded-lots-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-blinded-lots-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update blinded lot"
],
"summary":"v1.0",
"description":"Updates a blinded lot by study ID and blinded lot ID. Rights: LotManagementPost.",
"operationId":"updateBlindedLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of blinded lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotRequest"
},
"examples":{
"Update Blinded Lot Request":{
"description":"Update Blinded Lot Request",
"value":{
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB",
"0B8D7E696B6A4F3D8E544C5D2B7B8A91"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotId"
},
"examples":{
"Update Blinded Lot Response":{
"description":"Update Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"400":{
"description":"Blinded lot number or lot short name already exists. OR Expiration date is not valid. OR Invalid lot. OR Lot belongs to a blinded lot.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinded Lot Bad Request Response":{
"description":"Update Blinded Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot update request is invalid.",
"details":{
"field":"shortName",
"reason":"The blinded lot short name must be unique."
}
}
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinded Lot Forbidden Response":{
"description":"Update Blinded Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"updateBlindedLot",
"reason":"The caller does not have permission to update blinded lots."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinded Lot Server Error Response":{
"description":"Update Blinded Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while updating the blinded lot.",
"details":{
"operation":"updateBlindedLot",
"reason":"The blinded lot could not be updated."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-blinded-lots-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-blinded-lots-id-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Inventory APIs/Delete blinded lot"
],
"summary":"v1.0",
"description":"Removes blinded lot by study ID and blinded lot ID. Rights: LotManagementDelete.",
"operationId":"deleteBlindedLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of blinded lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/BlindedLotId"
},
"examples":{
"Delete Blinded Lot Response":{
"description":"Delete Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Blinded Lot Forbidden Response":{
"description":"Delete Blinded Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"deleteBlindedLot",
"reason":"The caller does not have permission to delete blinded lots."
}
}
}
}
}
}
}
},
"404":{
"description":"Blinded lot not found",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Blinded Lot Not Found Response":{
"description":"Delete Blinded Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinded lot was not found.",
"details":{
"field":"id",
"reason":"The supplied blinded lot identifier does not exist."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Blinded Lot Server Error Response":{
"description":"Delete Blinded Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while deleting the blinded lot.",
"details":{
"operation":"deleteBlindedLot",
"reason":"The blinded lot could not be deleted."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-blinded-lots-{id}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-blinded-lots-id-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/blindinggroups":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Get all blinding groups"
],
"summary":"v1.0",
"description":"Retrieves all blinding groups in a study. Required sponsor roles are: clinical supply manager and site manager.Please refer to getPackageTypes API for packageTypeId. A study cannot have both DEFAULT and RANDOM blinding group strategies. Based upon the single kit setting (RANDOM, DEFAULT, ALL) at a study level, the UI should restrict drop down values (SEND_KIT_TYPE/RANDOM_KIT). RANDOM_KIT should be hidden if the single kit setting at a study level is DEFAULT. Similarly, SEND_KIT_TYPE should be hidden if the single kit setting is RANDOMor ALL. getStudy API has been modified to return more parameters like singleKitSettingId and useBlindingGroups.
Rights: SupplySettingRightsPost.",
"operationId":"getBlindingGroups",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindingGroupResponse"
},
"examples":{
"Get Blinding Groups Response":{
"description":"Get Blinding Groups Response",
"value":{
"blindingGroups":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"title":"Blinding Group Lotion",
"description":"Some description.",
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5
}
],
"defaultBlindingKit":"392DA9F053E94B9B9339AC7D0FA0D1DB"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinding Groups Server Error Response":{
"description":"Get Blinding Groups Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while retrieving blinding groups.",
"details":{
"operation":"getBlindingGroups",
"reason":"The blinding group lookup failed."
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinding Groups Not Found Response":{
"description":"Get Blinding Groups Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"No blinding groups were found for the study.",
"details":{
"field":"studyId",
"reason":"The supplied study does not contain blinding groups."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-blindinggroups-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-blindinggroups-get"
},
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Create blinding group"
],
"summary":"v1.0",
"description":"Creates blinding group.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPostThe field groupDifferentPackageTypes is optional. Grouping different package types will be allowed if groupDifferentPackageTypes flag is set to Yes. Otherwise, this API operations throws an error saying that there are multiple package types in such cases.",
"operationId":"createBlindingGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Blinding group parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindingGroupRequest"
},
"examples":{
"Create Blinding Group Request":{
"description":"Create Blinding Group Request",
"value":{
"title":"Blinded Group Lotion",
"description":"Blinded Group Lotion",
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5
}
],
"groupDifferentPackageTypes":"Yes",
"defaultBlindingKit":"392DA9F053E94B9B9339AC7D0FA0D1DB"
}
}
}
}
},
"required":true
},
"responses":{
"201":{
"description":"Successful operation"
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinding Group Server Error Response":{
"description":"Create Blinding Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while creating the blinding group.",
"details":{
"operation":"createBlindingGroup",
"reason":"The blinding group could not be created."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinding Group Not Found Response":{
"description":"Create Blinding Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"A requested kit type or default blinding kit was not found.",
"details":{
"field":"defaultBlindingKit",
"reason":"The supplied default blinding kit identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"Validation message OR The following required parameters are missing OR Blinding Group already exist OR Invalid kit type OR Kit type ID already belongs to another blinding group OR Kit Types belong to different package types OR At least 2 kit types needed for grouping OR The following parameter values are invalid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinding Group Bad Request Response":{
"description":"Create Blinding Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinding group request is invalid.",
"details":{
"field":"kitTypes",
"reason":"At least one valid kit type must be supplied."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-blindinggroups-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-blindinggroups-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/blindinggroups/{blindingGroupId}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Get blinding group by ID"
],
"summary":"v1.0",
"description":"Retrieves blinding group in a study by blinding group ID.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"getBlindingGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"blindingGroupId",
"in":"path",
"description":"ID of blinding group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindingGroup"
},
"examples":{
"Get Blinding Group Response":{
"description":"Get Blinding Group Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"title":"Blinding Group Lotion",
"description":"Some description.",
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5
}
],
"defaultBlindingKit":"392DA9F053E94B9B9339AC7D0FA0D1DB"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinding Group Server Error Response":{
"description":"Get Blinding Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while retrieving the blinding group.",
"details":{
"operation":"getBlindingGroup",
"reason":"The blinding group lookup failed."
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study. OR Blinding Group not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinding Group Not Found Response":{
"description":"Get Blinding Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinding group was not found.",
"details":{
"field":"blindingGroupId",
"reason":"The supplied blinding group identifier does not exist."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-blindinggroups-{blindingGroupId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-blindinggroups-blindinggroupid-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Update blinding group"
],
"summary":"v1.0",
"description":"Updates blinding group. If the study has a DEFAULT single kit setting, defaultBlindingKit field is mandatory.
groupDifferentPackageTypes is an optional field. It will be defaulted to NO if it's not provided in the Request body.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost",
"operationId":"updateBlindingGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"blindingGroupId",
"in":"path",
"description":"ID of blinding group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Blinding group parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindingGroupRequest"
},
"examples":{
"Update Blinding Group Request":{
"description":"Update Blinding Group Request",
"value":{
"title":"Blinded Group Lotion",
"description":"Blinded Group Lotion",
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5
}
],
"groupDifferentPackageTypes":"Yes",
"defaultBlindingKit":"392DA9F053E94B9B9339AC7D0FA0D1DB"
}
}
}
}
},
"required":true
},
"responses":{
"204":{
"description":"Successful operation"
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinding Group Server Error Response":{
"description":"Update Blinding Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while updating the blinding group.",
"details":{
"operation":"updateBlindingGroup",
"reason":"The blinding group could not be updated."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found OR Blinding Group not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinding Group Not Found Response":{
"description":"Update Blinding Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinding group was not found.",
"details":{
"field":"blindingGroupId",
"reason":"The supplied blinding group identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"Validation error OR The following required parameters are missing OR Kit Types belong to different package types OR Kit type ID already belongs to another blinding group OR At least 2 kit types needed for grouping.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinding Group Bad Request Response":{
"description":"Update Blinding Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinding group update request is invalid.",
"details":{
"field":"title",
"reason":"The blinding group title exceeds the maximum length."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-blindinggroups-{blindingGroupId}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-blindinggroups-blindinggroupid-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Delete blinding group by ID"
],
"summary":"v1.0",
"description":"Removes blinding group from a study by blinding group ID.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"deleteBlindingGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"blindingGroupId",
"in":"path",
"description":"ID of blinding group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"204":{
"description":"Successful operation"
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Blinding Group Server Error Response":{
"description":"Delete Blinding Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while deleting the blinding group.",
"details":{
"operation":"deleteBlindingGroup",
"reason":"The blinding group delete request failed."
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study. OR Blinding group not found",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Blinding Group Invalid Study Response":{
"description":"Delete Blinding Group Invalid Study Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The study was not found.",
"details":{
"field":"studyId",
"reason":"The supplied study identifier does not exist."
}
}
}
},
"Delete Blinding Group Not Found Response":{
"description":"Delete Blinding Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinding group was not found.",
"details":{
"field":"blindingGroupId",
"reason":"The supplied blinding group identifier does not exist."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-blindinggroups-{blindingGroupId}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-blindinggroups-blindinggroupid-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kittypes/noblindinggroup":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Get kit types which do not belong to any blinding group"
],
"summary":"v1.0",
"description":"Retrieves kit types which do not belong to any blinding group.
Rights: SupplySettingRightsGet.
Required sponsor roles are: clinical supply manager and site manager.",
"operationId":"getKitTypesNotInBlindingGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitType"
}
},
"examples":{
"Get Kit Types Not In Blinding Group Response":{
"description":"Get Kit Types Not In Blinding Group Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"versionStart":"23-NOV-2018 08.43.01.700136000 AM",
"versionEnd":"23-NOV-2018 08.43.01.700136000 AM",
"countsPerPackage":5,
"description":"Non-Dosing",
"doNotDispense":1,
"dosage":1,
"minShippingUnits":10,
"packageTypeId":10,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"23-NOV-2018 08.43.01.700136000 AM",
"isDefault":true,
"kitTypeName":"Kit A",
"storageNeedId":1,
"srcId":"B1B8327AFAA6412287106192AB5984EF",
"srcVersionStart":"23-NOV-2018 08.43.01.700136000 AM"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Types Not In Blinding Group Server Error Response":{
"description":"Get Kit Types Not In Blinding Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while retrieving kit types not assigned to a blinding group.",
"details":{
"operation":"getKitTypesNotInBlindingGroup",
"reason":"The kit type lookup failed."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Types Not In Blinding Group Not Found Response":{
"description":"Get Kit Types Not In Blinding Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"No kit types were found for the study.",
"details":{
"field":"studyId",
"reason":"The supplied study does not contain eligible kit types."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kittypes-noblindinggroup-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kittypes-noblindinggroup-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/cohortenrollments/{cohortid}":{
"get":{
"tags":[
"Randomization and Supplies/Cohort APIs/Get cohort enrollments by study, mode and cohort ID"
],
"summary":"v1.0",
"description":"Retrieves cohort enrollments by study, mode and cohort ID. Rights: SubjectSettingRightsGet.",
"operationId":"getCohortEnrollments",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"cohortid",
"in":"path",
"description":"ID of the cohort.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CohortEnrollments"
},
"examples":{
"Get Cohort Enrollments Response":{
"description":"Get Cohort Enrollments Response",
"value":{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"randomizationLimit":5,
"notificationLimit":5,
"randomizedSubjects":5,
"enabled":true,
"enrollmentLimitReached":true
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Cohort Enrollments Server Error Response":{
"description":"Get Cohort Enrollments Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"COHORT-500",
"errorMessage":"Unexpected error while retrieving cohort enrollments."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-cohortenrollments-{cohortid}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-cohortenrollments-cohortid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/settings/cohortlimits":{
"get":{
"tags":[
"Randomization and Supplies/Cohort APIs/Get cohort limits by study and mode"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves cohort limits by study and mode. Rights: SubjectSettingRightsGet.",
"operationId":"getCohortLimits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortLimit"
}
},
"examples":{
"Get Cohort Limits Response":{
"description":"Get Cohort Limits Response",
"value":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"randomizationLimit":5,
"notificationLimit":5,
"enabled":true
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Cohort Limits Server Error Response":{
"description":"Get Cohort Limits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"COHORT-500",
"errorMessage":"Unexpected error while retrieving cohort limits."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-settings-cohortlimits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-settings-cohortlimits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Cohort APIs/Save cohort limits by study and mode"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Saves cohort limits by study and mode. Rights: SubjectSettingRightsPost.",
"operationId":"setCohortLimits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"fromMode",
"in":"query",
"description":"From mode.",
"schema":{
"type":"string"
},
"example":"test"
}
],
"requestBody":{
"description":"Cohort limits.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/CohortLimitList"
},
"examples":{
"Set Cohort Limits Request":{
"description":"Set Cohort Limits Request",
"value":{
"cohortLimits":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"randomizationLimit":5,
"notificationLimit":5,
"enabled":true
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortLimit"
}
},
"examples":{
"Set Cohort Limits Response":{
"description":"Set Cohort Limits Response",
"value":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"randomizationLimit":5,
"notificationLimit":5,
"enabled":true
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Set Cohort Limits Server Error Response":{
"description":"Set Cohort Limits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"COHORT-500",
"errorMessage":"Unexpected error while saving cohort limits."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-settings-cohortlimits-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-settings-cohortlimits-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/recon/shipments":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create shipment for kits marked for destruction from a given site to depot"
],
"summary":"v1.0",
"description":"Retrieves a list of resupply orders where each order contains an order ID and an order status. In the request body, kitRange should have the following format: KIT_NUMBER:min:max. Rights: OrsInventoryPost and either SourceDataVerification or OrsUnblinded.",
"operationId":"createShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReconShipmentRequest"
},
"examples":{
"Create Recon Shipment Request":{
"description":"Create Recon Shipment Request",
"value":{
"kits":[
"E39FF55A445543A38D513325664F0B2D"
],
"kitsFilter":{
"kitRange":"KIT_NUMBER:10:100",
"searchString":"Some search string",
"inventoryStatusIds":[
5
],
"subjectId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ResupplyResponse"
}
},
"examples":{
"Create Recon Shipment Response":{
"description":"Create Recon Shipment Response",
"value":[
{
"orderId":"B1B8327AFAA6412287106192AB5984EF",
"status":"DESTROYED"
}
]
}
}
}
}
},
"404":{
"description":"Site ID not found in site service.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Recon Shipment Not Found Response":{
"description":"Create Recon Shipment Not Found Response",
"value":{
"errorCode":"RECON-SHIPMENT-404",
"errorMessage":"Site or kits were not found for the reconciliation shipment request.",
"details":{
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"missingKitId":"E39FF55A445543A38D513325664F0B2D"
}
}
}
}
}
}
},
"400":{
"description":"'Kit reconciliation required was not set.', 'You cannot update the status of this kit because the kit was sent to a depot', 'You cannot update the status of this kit because it is at a site that you do not have access to. Work with your CRA or a clinical supply manager to update the kit.', 'Reconciliation shipment is not allowed as site has drug destruction capability.', 'Reconciliation shipment cannot be created as none of the depots has drug destruction capability.', 'Update kits cannot have both the kit identifiers list and the kits filter set.', 'Update kits must have either the kit identifiers list or the kits filter set.', 'Invalid inventory status transition.', 'Invalid kit at site.', 'Invalid kit range filter.', 'subjectId is required.', 'Invalid subject.', 'Update kits no rows were found to update.', 'Update kits retrieved size exceeds maximum rows for update limit of.', 'Update kits retrieve error, the following kit identifiers were not found.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Recon Shipment Bad Request Response":{
"description":"Create Recon Shipment Bad Request Response",
"value":{
"errorCode":"ORS-076",
"errorMessage":"Invalid kit range filter.",
"details":{
"field":"kitsFilter.kitRange",
"issue":"Use KIT_NUMBER:start:end with start less than or equal to end."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Recon Shipment Server Error Response":{
"description":"Create Recon Shipment Server Error Response",
"value":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while creating the reconciliation shipment.",
"details":{
"operation":"createShipment",
"issue":"Unable to persist reconciliation shipment."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-recon-shipments-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-recon-shipments-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/dbheaders/uploadkits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get inventory database headers"
],
"summary":"v1.0",
"description":"Retrieves inventory headers from the database.",
"operationId":"getInventoryDBHeaders",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"type":"array",
"items":{
"type":"string",
"enum":[
"KIT_TYPE",
"KIT_NUMBER",
"SEQUENCE_NUMBER",
"BAR_CODE",
"BLOCK_NUMBER"
]
}
},
"examples":{
"Inventory DB Headers":{
"description":"Inventory DB Headers",
"value":{
"dbHeaders":[
"Kit Number",
"Kit Type",
"Lot Number"
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory DB Headers Server Error Response":{
"description":"Get Inventory DB Headers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving inventory database headers.",
"details":{
"operation":"getInventoryDBHeaders",
"reason":"The inventory database headers could not be loaded."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-dbheaders-uploadkits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-dbheaders-uploadkits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/dbheaders/uploadrndlist":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get randomization list database headers"
],
"summary":"v1.0",
"description":"Retrieves randomization list headers from the database.",
"operationId":"getRndListDBHeaders",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"type":"array",
"items":{
"type":"string",
"enum":[
"RND_NUM",
"BLOCK",
"TREATMENT",
"STRATUM",
"COHORT",
"PROB_FCTR",
"SEQUENCE_NUMBER"
]
}
},
"examples":{
"Randomization List DB Headers":{
"description":"Randomization List DB Headers",
"value":{
"dbHeaders":[
"Randomization Number",
"Treatment",
"Block",
"Stratum",
"Cohort"
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List DB Headers Server Error Response":{
"description":"Get Randomization List DB Headers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving randomization list database headers.",
"details":{
"operation":"getRndListDBHeaders",
"reason":"The randomization list database headers could not be loaded."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-dbheaders-uploadrndlist-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-dbheaders-uploadrndlist-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/dndexception":{
"get":{
"tags":[
"Randomization and Supplies/Dispensation Logic APIs/Get all DND Exceptions"
],
"summary":"v1.0",
"description":"Retrieves all details of the DND Exceptions. Rights: DispensationExceptionGet.",
"operationId":"getDNDExceptions",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DNDExceptionsResponse"
},
"examples":{
"Get DND Exceptions Response":{
"description":"Get DND Exceptions Response",
"value":{
"dndExceptions":[
{
"dndExceptionId":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeSrcId":[
"6AF54DB79B764662B685D68C52AB0B84"
],
"allCountries":false,
"countries":[
"US"
],
"visitDND":[
{
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"dnd":2
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get DND Exceptions Server Error Response":{
"description":"Get DND Exceptions Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-500",
"errorMessage":"Unexpected error while retrieving DND exceptions.",
"details":{
"operation":"getDNDExceptions"
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get DND Exceptions Not Found Response":{
"description":"Get DND Exceptions Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-404",
"errorMessage":"The study or requested version was not found.",
"details":{
"studyId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
}
},
"400":{
"description":"Dispensation logic (dynamic DND) request is not valid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get DND Exceptions Bad Request Response":{
"description":"Get DND Exceptions Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-400",
"errorMessage":"The DND exception retrieval request is invalid.",
"details":{
"field":"studyId",
"reason":"The study context is invalid."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-dndexception-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-dndexception-get"
},
"post":{
"tags":[
"Randomization and Supplies/Dispensation Logic APIs/Create DND Exception"
],
"summary":"v1.0",
"description":"Creates a DND Exception. Rights needed: DispensationExceptionPost.",
"operationId":"create",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Creates a DND Exception. Rights needed: DispensationExceptionPost.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DNDExceptionRequestV1"
},
"examples":{
"Create DND Exception Request":{
"description":"Create DND Exception Request",
"value":{
"kitTypeSrcId":[
"6AF54DB79B764662B685D68C52AB0B84"
],
"allCountries":false,
"countries":[
"US"
],
"visitDND":[
{
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"dnd":2
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create DND Exception Response":{
"description":"Create DND Exception Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create DND Exception Server Error Response":{
"description":"Create DND Exception Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-500",
"errorMessage":"Unexpected error while creating the DND exception.",
"details":{
"operation":"createDNDException"
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create DND Exception Not Found Response":{
"description":"Create DND Exception Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-404",
"errorMessage":"The study or requested version was not found.",
"details":{
"studyId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
}
},
"400":{
"description":"Dispensation logic (dynamic DND) request is not valid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create DND Exception Bad Request Response":{
"description":"Create DND Exception Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-400",
"errorMessage":"The DND exception request is invalid.",
"details":{
"field":"visitDND",
"reason":"At least one visit DND rule must be provided."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-dndexception-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-dndexception-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/dndexception/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Dispensation Logic APIs/Get DND Exception details by ID"
],
"summary":"v1.0",
"description":"Retrieves DND Exception details by DND Exception ID. Rights: OrsInventoryGet.",
"operationId":"getDNDExceptionsById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"id",
"in":"path",
"description":"DND Exception ID.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DNDExceptionListResponse"
},
"examples":{
"Get DND Exception By Id Response":{
"description":"Get DND Exception By Id Response",
"value":{
"dndExceptionId":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeSrcId":[
"6AF54DB79B764662B685D68C52AB0B84"
],
"allCountries":true,
"countries":[
],
"siteIds":[
],
"visitDND":[
{
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"dnd":3
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get DND Exception By Id Server Error Response":{
"description":"Get DND Exception By Id Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-500",
"errorMessage":"Unexpected error while retrieving the DND exception.",
"details":{
"operation":"getDNDExceptionsById"
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get DND Exception By Id Not Found Response":{
"description":"Get DND Exception By Id Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-404",
"errorMessage":"The DND exception was not found.",
"details":{
"dndExceptionId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
}
},
"400":{
"description":"Dispensation logic (dynamic DND) request is not valid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get DND Exception By Id Bad Request Response":{
"description":"Get DND Exception By Id Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-400",
"errorMessage":"The DND exception identifier is invalid.",
"details":{
"field":"id",
"reason":"The DND exception identifier must be a valid UUID."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-dndexception-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-dndexception-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Dispensation Logic APIs/Update DND Exception"
],
"summary":"v1.0",
"description":"Updates a DND Exception. Rights needed: DispensationExceptionPost.",
"operationId":"update",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"id",
"in":"path",
"description":"DND Exception ID.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Updates a DND Exception. Rights needed: DispensationExceptionPost.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DNDExceptionRequestV1"
},
"examples":{
"Update DND Exception Request":{
"description":"Update DND Exception Request",
"value":{
"kitTypeSrcId":[
"6AF54DB79B764662B685D68C52AB0B84"
],
"allCountries":true,
"visitDND":[
{
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"dnd":3
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update DND Exception Response":{
"description":"Update DND Exception Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update DND Exception Server Error Response":{
"description":"Update DND Exception Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-500",
"errorMessage":"Unexpected error while updating the DND exception.",
"details":{
"operation":"updateDNDException"
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update DND Exception Not Found Response":{
"description":"Update DND Exception Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-404",
"errorMessage":"The study or DND exception was not found.",
"details":{
"dndExceptionId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
}
},
"400":{
"description":"Dispensation logic (dynamic DND) request is not valid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update DND Exception Bad Request Response":{
"description":"Update DND Exception Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-400",
"errorMessage":"The DND exception update request is invalid.",
"details":{
"field":"visitDND",
"reason":"The DND value is not valid for the specified visit."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-dndexception-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-dndexception-id-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Dispensation Logic APIs/Delete DND Exception"
],
"summary":"v1.0",
"description":"Deletes a DND Exception. Rights needed: DispensationExceptionPost.",
"operationId":"delete",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"id",
"in":"path",
"description":"DND Exception ID.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Delete DND Exception Response":{
"description":"Delete DND Exception Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete DND Exception Server Error Response":{
"description":"Delete DND Exception Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-500",
"errorMessage":"Unexpected error while deleting the DND exception.",
"details":{
"operation":"deleteDNDException"
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete DND Exception Not Found Response":{
"description":"Delete DND Exception Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-404",
"errorMessage":"The DND exception was not found.",
"details":{
"dndExceptionId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
}
},
"400":{
"description":"Dispensation logic (dynamic DND) request is not valid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete DND Exception Bad Request Response":{
"description":"Delete DND Exception Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DND-400",
"errorMessage":"The DND exception delete request is invalid.",
"details":{
"field":"id",
"reason":"The DND exception identifier is invalid."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-dndexception-{id}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-dndexception-id-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create shipment for kits marked for destruction in a study"
],
"summary":"v1.0",
"description":"Retrieves a list of resupply orders where each order contains an order ID and an order status. In the request body, kitRange should have the following format: KIT_NUMBER:min:max. Rights: OrsInventoryPost and either SourceDataVerification or OrsUnblinded.",
"operationId":"createDepotReconShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Manual depot-to-depot supply request parameter.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManualDepotSupplyRequest"
},
"examples":{
"Create Depot Recon Shipment Request":{
"description":"Create Depot Recon Shipment Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E",
"kits":[
{
"kitTypeId":"B1B8327AFAA6412287106192AB5984EF",
"quantity":"2"
}
],
"shippedFrom":"B1B8327AFAA6412287106192AB5984EF",
"shippedTo":"ABC8327AFAA6412287106192AB5984EF"
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Depot Recon Shipment Response":{
"description":"Create Depot Recon Shipment Response",
"value":{
"status":"success",
"result":null,
"errorData":null,
"version":1
}
}
}
}
}
},
"404":{
"description":"Site ID not found in site service.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Depot Recon Shipment Not Found Response":{
"description":"Create Depot Recon Shipment Not Found Response",
"value":{
"errorCode":"DEPOT-RECON-404",
"errorMessage":"The depot or requested kits were not found.",
"details":{
"shippedFrom":"B1B8327AFAA6412287106192AB5984EF",
"missingKitTypeId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
},
"400":{
"description":"'Kit reconciliation required was not set.','You can't update the status of this kit because the kit was sent to a depot.','You can't update the status of this kit because it's at a site that you don't have access to. Work with your clinical research associate or a clinical supply manager to update the kit.','Reconciliation shipment is not allowed as site has drug destruction capability.','Reconciliation shipment cannot be created as none of the depots have drug destruction capability.','Update kits cannot have both the kit identifiers list and the kits filter set.','Update kits must have either the kit identifiers list or the kits filter set.','Invalid inventory status transition.','Invalid kit at site.', 'Invalid kit range filter.', 'Subject ID is required.','Invalid subject.', 'Update kits no rows were found to update.','Update kits retrieved size exceeds maximum rows for update limit of.','Update kits retrieve error, the following kit identifiers were not found.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Depot Recon Shipment Bad Request Response":{
"description":"Create Depot Recon Shipment Bad Request Response",
"value":{
"errorCode":"DEPOT-RECON-400",
"errorMessage":"The depot reconciliation shipment request is invalid.",
"details":{
"field":"kits[0].quantity",
"issue":"Quantity must be greater than zero."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Depot Recon Shipment Server Error Response":{
"description":"Create Depot Recon Shipment Server Error Response",
"value":{
"errorCode":"DEPOT-RECON-500",
"errorMessage":"Unexpected error while creating the depot reconciliation shipment.",
"details":{
"operation":"createDepotReconShipment",
"issue":"Unable to create depot reconciliation shipment."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/doseholdsettings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Get all dose hold settings details"
],
"summary":"v1.0",
"description":"Retrieves all dose hold settings details. Rights required:SupplySettingRightsGet.",
"operationId":"getDoseHolds",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ListResponse"
},
"examples":{
"Dose Hold Settings List":{
"description":"Dose Hold Settings List",
"value":{
"Resources":[
{
"doseHoldID":"F0E1D2C3B4A5968778695A4B3C2D1E0F",
"reason":"Initial configuration",
"comment":"Dose hold enabled for titration visits",
"operationType":"CREATE",
"objectVersionNumber":1,
"userID":"D313327EF13845169A8ADADDA435431E",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"startingVisitSrcId":"0A1B2C3D4E5F678890AABBCCDDEEFF11",
"instanceNumber":5,
"enabled":true,
"maxDoseHolds":10,
"frequencyUnlimited":true,
"frequencyLimitInSequence":2,
"frequencyLimitInDays":14
}
],
"schemas":[
"urn:nextgen:schemas:resource:1.0::ListResponse"
],
"totalResults":1
}
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Hold Settings Bad Request Response":{
"description":"Dose Hold Settings Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-400",
"errorMessage":"The dose hold settings request is invalid.",
"details":{
"field":"studyId",
"reason":"The study identifier is invalid."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-doseholdsettings-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-doseholdsettings-get"
},
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Create dose hold settings for the given dose hold"
],
"summary":"v1.0",
"description":"Adds dose hold setting for a given dose hold. Rights required:SupplySettingRightsPost.",
"operationId":"createDoseHoldSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldSettingsRequestV1"
},
"examples":{
"Create Dose Hold Settings Request":{
"description":"Create Dose Hold Settings Request",
"value":{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"startingVisitSrcId":"0A1B2C3D4E5F678890AABBCCDDEEFF11",
"enabled":true,
"frequencyUnlimited":true,
"instanceNumber":5,
"maxDoseHolds":10,
"frequencyLimitInSequence":2,
"frequencyLimitInDays":14
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldResponse"
},
"examples":{
"Create Dose Hold Settings Response":{
"description":"Create Dose Hold Settings Response",
"value":{
"doseHoldId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold Setting Details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Dose Hold Settings Bad Request Response":{
"description":"Create Dose Hold Settings Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-400",
"errorMessage":"The dose hold settings payload is invalid.",
"details":{
"field":"maxDoseHolds",
"reason":"The maximum number of dose holds must be greater than zero."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-doseholdsettings-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-doseholdsettings-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/doseholdsettings/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Get dose hold setting details of given dose hold by ID"
],
"summary":"v1.0",
"description":"Retrieves dose hold setting details of given dose hold identified by ID. Rights required:SupplySettingRightsGet.",
"operationId":"getDoseHoldById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"id",
"in":"path",
"description":"Dose Hold ID.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"F0E1D2C3B4A5968778695A4B3C2D1E0F"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldSettingsResponseTO"
},
"examples":{
"Dose Hold Settings Id":{
"description":"Dose Hold Settings Id",
"value":{
"doseHoldID":"F0E1D2C3B4A5968778695A4B3C2D1E0F",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"startingVisitSrcId":"0A1B2C3D4E5F678890AABBCCDDEEFF11",
"instanceNumber":5,
"enabled":true,
"maxDoseHolds":10,
"frequencyUnlimited":true,
"frequencyLimitInSequence":2,
"frequencyLimitInDays":14,
"reason":"Initial configuration",
"comment":"Dose hold enabled for titration visits"
}
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Hold Settings By Id Bad Request Response":{
"description":"Dose Hold Settings By Id Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-400",
"errorMessage":"The dose hold identifier is invalid.",
"details":{
"field":"id",
"reason":"The supplied identifier does not match the expected format."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-doseholdsettings-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-doseholdsettings-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Update dose hold settings of a given dose hold by ID"
],
"summary":"v1.0",
"description":"Updates dose hold settings of a given dose hold identified by ID. Rights required: SupplySettingRightsPost.",
"operationId":"updateDoseHoldSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"id",
"in":"path",
"description":"Dose Hold ID.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"F0E1D2C3B4A5968778695A4B3C2D1E0F"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldSettingsRequestV1"
},
"examples":{
"Update Dose Hold Settings Request":{
"description":"Update Dose Hold Settings Request",
"value":{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"startingVisitSrcId":"0A1B2C3D4E5F678890AABBCCDDEEFF11",
"enabled":true,
"frequencyUnlimited":false,
"instanceNumber":3,
"maxDoseHolds":5,
"frequencyLimitInSequence":1,
"frequencyLimitInDays":7
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldResponse"
},
"examples":{
"Update Dose Hold Settings Response":{
"description":"Update Dose Hold Settings Response",
"value":{
"doseHoldId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold Setting Details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Dose Hold Settings Bad Request Response":{
"description":"Update Dose Hold Settings Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-400",
"errorMessage":"The dose hold settings update payload is invalid.",
"details":{
"field":"frequencyLimitInDays",
"reason":"The frequency limit in days must be zero or greater."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-doseholdsettings-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-doseholdsettings-id-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Delete dose hold settings of a given dose hold by ID"
],
"summary":"v1.0",
"description":"Deletes dose hold setting details of a given dose hold identified by ID. Rights required: SupplySettingRightsPost.",
"operationId":"deleteDoseHoldById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"id",
"in":"path",
"description":"Dose Hold ID to delete.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"F0E1D2C3B4A5968778695A4B3C2D1E0F"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Deleted Dose Hold Id":{
"description":"Deleted Dose Hold Id",
"value":"F0E1D2C3B4A5968778695A4B3C2D1E0F"
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Dose Hold Bad Request Response":{
"description":"Delete Dose Hold Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-400",
"errorMessage":"The dose hold record could not be deleted.",
"details":{
"field":"id",
"reason":"The supplied identifier is invalid."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-doseholdsettings-{id}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-doseholdsettings-id-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/events/codebreak/{eventId}":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get details about a Code Break event"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves details about a Code Break event in the study. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeBreakEvent",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"eventId",
"in":"path",
"description":"ID of event.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Codebreak Event Payload":{
"description":"Codebreak Event Payload",
"value":{
}
}
}
}
}
},
"404":{
"description":"Study identifier does not match any study identifiers in Clinical One. OR Event not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Code Break Event Not Found Response":{
"description":"Get Code Break Event Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-404",
"errorMessage":"The requested code break event was not found."
}
}
}
}
}
}
},
"400":{
"description":"Incorrect event type. Or No data found for the event.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Code Break Event Bad Request Response":{
"description":"Get Code Break Event Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-400",
"errorMessage":"The event identifier is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Code Break Event Server Error Response":{
"description":"Get Code Break Event Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-500",
"errorMessage":"Unexpected error while retrieving the code break event."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-events-codebreak-{eventId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-events-codebreak-eventid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/events":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get list of events in a study"
],
"summary":"v1.0",
"description":"Retrieves a list of events in a study based on start date and end date. Rights: OrsSubjectVisitGet. If no events are specified, all the events in action types are returned. If event types are specified, but none of them are valid, an empty list is returned.",
"operationId":"getEvents",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"events",
"in":"query",
"description":"List of events.",
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"example":"New"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-01-01T00:00:00Z"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-01-31T23:59:59Z"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/EventsDTO"
},
"examples":{
"Events Response":{
"description":"Events Response",
"value":{
"events":[
{
"eventType":"New",
"ids":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Events Server Error Response":{
"description":"Get Events Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-500",
"errorMessage":"Unexpected error while retrieving events."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-events-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-events-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/events/kitreplacement/{eventId}":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get details about a Kit Replacement event"
],
"summary":"v1.0",
"description":"Retrieves details on kit replacement events for a subject. Rights: OrsSubjectVisitGet.",
"operationId":"getKitReplacementEvent",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"eventId",
"in":"path",
"description":"ID of event.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Kit Replacement Event Payload":{
"description":"Kit Replacement Event Payload",
"value":{
}
}
}
}
}
},
"404":{
"description":"Study identifier does not match any study identifiers in Clinical One. OR Event not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Replacement Event Not Found Response":{
"description":"Get Kit Replacement Event Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-404",
"errorMessage":"The requested kit replacement event was not found."
}
}
}
}
}
}
},
"400":{
"description":"Incorrect event type OR no data found for the event",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Replacement Event Bad Request Response":{
"description":"Get Kit Replacement Event Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-400",
"errorMessage":"The event identifier is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Replacement Event Server Error Response":{
"description":"Get Kit Replacement Event Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-500",
"errorMessage":"Unexpected error while retrieving the kit replacement event."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-events-kitreplacement-{eventId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-events-kitreplacement-eventid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/events/resume_dosehold_dispensation/{eventId}":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get details about a Resume dose hold dispensation event"
],
"summary":"v1.0",
"description":"Retrieves details on resume dose hold dispensation events for a subject. Rights: OrsSubjectVisitGet.",
"operationId":"getResumeDoseHoldDispensationEvent",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"eventId",
"in":"path",
"description":"ID of event.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Resume Dose Hold Dispensation Payload":{
"description":"Resume Dose Hold Dispensation Payload",
"value":{
}
}
}
}
}
},
"404":{
"description":"Study identifier does not match any study identifiers in Clinical One. OR Event not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resume Dose Hold Dispensation Event Not Found Response":{
"description":"Get Resume Dose Hold Dispensation Event Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-404",
"errorMessage":"The requested resume dose hold dispensation event was not found."
}
}
}
}
}
}
},
"400":{
"description":"Incorrect event type OR no data found for the event",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resume Dose Hold Dispensation Event Bad Request Response":{
"description":"Get Resume Dose Hold Dispensation Event Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-400",
"errorMessage":"The event identifier is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resume Dose Hold Dispensation Event Server Error Response":{
"description":"Get Resume Dose Hold Dispensation Event Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-500",
"errorMessage":"Unexpected error while retrieving the resume dose hold dispensation event."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-events-resume_dosehold_dispensation-{eventId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-events-resume_dosehold_dispensation-eventid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/events/resume_partial_dispensation/{eventId}":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get details about a Resume Partial Dispensation event"
],
"summary":"v1.0",
"description":"Retrieves details on resume partial dispensation events for a subject. Rights: OrsSubjectVisitGet.",
"operationId":"getResumePartialDispensationEvent",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"eventId",
"in":"path",
"description":"ID of event.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Resume Partial Dispensation Payload":{
"description":"Resume Partial Dispensation Payload",
"value":{
}
}
}
}
}
},
"404":{
"description":"Study identifier does not match any study identifiers in Clinical One. OR Event not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resume Partial Dispensation Event Not Found Response":{
"description":"Get Resume Partial Dispensation Event Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-404",
"errorMessage":"The requested resume partial dispensation event was not found."
}
}
}
}
}
}
},
"400":{
"description":"Incorrect event type OR no data found for the event",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resume Partial Dispensation Event Bad Request Response":{
"description":"Get Resume Partial Dispensation Event Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-400",
"errorMessage":"The event identifier is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resume Partial Dispensation Event Server Error Response":{
"description":"Get Resume Partial Dispensation Event Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"EVENT-500",
"errorMessage":"Unexpected error while retrieving the resume partial dispensation event."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-events-resume_partial_dispensation-{eventId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-events-resume_partial_dispensation-eventid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/fileupload/rndlists/{rndListId}":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create randomization list from uploaded file"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Creates a randomization list from an uploaded file. Rights: DesignerRandListUpload. This API operation stores file data against the specified randomization list. File ID is a unique identifier for the uploaded file received from File Upload Services.",
"operationId":"uploadRndList",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF00"
},
{
"name":"rndListId",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"fileId",
"in":"query",
"description":"ID of the file.",
"required":true,
"schema":{
"type":"string"
},
"example":"8C5C1C4D0E1F2A3B4C5D6E7F8091A2B3"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"*/*":{
"examples":{
"Upload Randomization List Success (No Content)":{
"description":"Upload succeeds with no response body."
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Randomization List Server Error Response":{
"description":"Upload Randomization List Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while uploading the randomization list file.",
"details":{
"operation":"uploadRndList",
"reason":"The randomization list file could not be attached to the list."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-fileupload-rndlists-{rndListId}-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-fileupload-rndlists-rndlistid-post"
}
},
"/ec-ors-svc/rest/v1.0/import/{studyId}/{version}":{
"post":{
"tags":[
"Randomization and Supplies/Study Import APIs/Get unique values for treatments, stratums or cohorts from a CSV file"
],
"summary":"v1.0",
"description":"Retrieves unique values for treatment arms, stratums and/or cohorts from a CSV file. Rights: OrsImportDesignPost.",
"operationId":"doImport",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
},
{
"name":"version",
"in":"path",
"description":"Version of the study.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-21T06:30:00Z"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"*/*":{
"examples":{
"Import study design":{
"description":"Import study design"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server error":{
"description":"Server error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"IMPORT-500",
"errorMessage":"Unexpected error while importing the study design.",
"details":{
"studyId":"8ECE2C9D389645B09740DC7926DEFB69",
"version":"2026-02-21T06:30:00Z"
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-import-{studyId}-{version}-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-import-studyid-version-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/depots/{depotId}/inventory/kits/{inventoryId}/historyById":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get Kit History by depot ID and kit ID"
],
"summary":"v1.0",
"description":"Retrieves kit history by depot ID. Rights: BlindedDepotUser.",
"operationId":"getDepotKitHistoryById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"depotId",
"in":"path",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical depot",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
},
"examples":{
"Get Depot Kit Status History Response":{
"description":"Get Depot Kit Status History Response",
"value":{
"inventoryStatusId":5,
"inventoryStatus":"Available",
"reason":"Status updated during reconciliation",
"returnedUnits":10,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Depot Kit Status History Server Error Response":{
"description":"Get Depot Kit Status History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving depot kit history."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Depot Kit Status History Not Found Response":{
"description":"Get Depot Kit Status History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The depot kit history was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Depot Kit Status History Bad Request Response":{
"description":"Get Depot Kit Status History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The depot inventory identifier is invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-depots-{depotId}-inventory-kits-{inventoryId}-historyById-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-depots-depotid-inventory-kits-inventoryid-historybyid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/depots/{depotId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kits from depot inventory by depot ID"
],
"summary":"v1.0",
"description":"Retrieves a list of inventories based on the filters passed in the request. Rights: ORSBlindedDepotGet, returns list of inventories at the depot for the passed filters.",
"operationId":"getDepotKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"depotId",
"in":"path",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical depot",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"searchByKitNumber",
"in":"query",
"description":"Kit Number search string.",
"schema":{
"type":"string"
},
"example":"KIT-0001"
},
{
"name":"searchBySeqNumber",
"in":"query",
"description":"Sequence number search string.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"sequenceNumberMin",
"in":"query",
"description":"Minimum sequence number for search",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"sequenceNumberMax",
"in":"query",
"description":"Maximum sequence number for search",
"schema":{
"type":"number"
},
"example":100
},
{
"name":"kitNumberMin",
"in":"query",
"description":"Minimum kit number for search",
"schema":{
"type":"number"
},
"example":10001
},
{
"name":"kitNumberMax",
"in":"query",
"description":"Maximum kit number for search",
"schema":{
"type":"number"
},
"example":10100
},
{
"name":"blindedLotId",
"in":"query",
"description":"Blinded lot ID for search",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentNumber",
"in":"query",
"description":"Shipment number for search",
"schema":{
"type":"string"
},
"example":"SHIP-0001"
},
{
"name":"quarantineId",
"in":"query",
"description":"Quarantine ID for search",
"schema":{
"type":"string"
},
"example":"Q-0001"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32",
"default":0
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32",
"default":100
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":5
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DepotKitDetailsResponseV1"
},
"examples":{
"Get Depot Kits Response":{
"description":"Get Depot Kits Response",
"value":{
"distinctInventoryStatusIds":[
5,
10
],
"blindedLotsExistsInStudy":true,
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumberUTF":"10001",
"sequenceNumber":1,
"blockNumber":"BLK-001",
"inventoryStatusId":5,
"inventoryStatus":"Available",
"unitsPerKit":30,
"kitDescription":"Bottle of tablets",
"distributionSetting":"BLINDED",
"barCode":"BAR-10001",
"blindedLotExpirationDate":"2026-12-31T00:00:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Depot Kits Server Error Response":{
"description":"Get Depot Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving depot kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID OR study still in design phase OR invalid depot ID OR invalid subject ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Depot Kits Not Found Response":{
"description":"Get Depot Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The depot was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Depot Kits Bad Request Response":{
"description":"Get Depot Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The depot kit filters are invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-depots-{depotId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-depots-depotid-inventory-kits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit attributes from depot inventory by depot ID"
],
"summary":"v1.0",
"description":"Updates kit attributes from depot inventory by depot ID, based on the filters passed in the request. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKitAttributes",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"depotId",
"in":"path",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical depot",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Kit attribute parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateDepotKitsRequestV1"
},
"examples":{
"Update Depot Kits Request":{
"description":"Update Depot Kits Request",
"value":{
"kitsFilter":{
"searchByKitNumber":"KIT-0001",
"searchBySeqNumber":1,
"sequenceNumberMin":1,
"sequenceNumberMax":100,
"kitNumberMin":10001,
"kitNumberMax":10100,
"blindedLotId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"SHIP-0001",
"quarantineId":"0000000000001",
"inventoryStatusIds":[
5,
10
]
},
"kits":[
"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"reason":"Kit damaged during shipment",
"inventoryStatusId":10
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateDepotKitsResponse"
},
"examples":{
"Update Depot Kit Attributes Response":{
"description":"Update Depot Kit Attributes Response",
"value":{
"tempExcursionNumber":"0000000000001",
"transactionId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Depot Kit Attributes Not Found Response":{
"description":"Update Depot Kit Attributes Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The depot kit record was not found."
}
}
}
}
}
}
},
"400":{
"description":"Specify at least one kit attribute OR Reason is required OR Specify at least one filter. OR Either kits or kitFilters is required OR Invalid kit status OR Invalid kit range filter OR Invalid lot OR Invalid label group in kit filters OR Invalid kit type OR Invalid location OR No kits to update OR Update kits retrieved size exceeds maximum rows for update limit OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Depot Kit Attributes Bad Request Response":{
"description":"Update Depot Kit Attributes Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The depot kit update request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Depot Kit Attributes Server Error Response":{
"description":"Update Depot Kit Attributes Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating depot kit attributes."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-depots-{depotId}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-depots-depotid-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/{sourceId}/export":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Export kit details for the inventory"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Exports kit details for the inventory source as a CSV file. Rights: DesignerKitListGet.",
"operationId":"export",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"sourceId",
"in":"path",
"description":"Source ID of the inventory.",
"required":true,
"schema":{
"type":"string"
},
"example":"INV-SRC-0001"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"*/*":{
"examples":{
"Export Inventory Kits Success (No Content)":{
"description":"Export is streamed as a file download; response has no body."
}
}
}
}
},
"404":{
"description":"No matching inventory source is available",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Export Inventory Kits Not Found Response":{
"description":"Export Inventory Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The inventory source was not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Export Inventory Kits Server Error Response":{
"description":"Export Inventory Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while exporting inventory kits."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{sourceId}-export-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-sourceid-export-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/{kitId}/confirmDispensation":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update a kit's dispensation confirmation"
],
"summary":"v1.0",
"description":"Updates a kit's dispensation confirmation. Rights: OrsInventoryPost.",
"operationId":"confirmDispensation",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Confirm Dispensation Response":{
"description":"Confirm Dispensation Response",
"value":{
"id":"1bc29b36-f5d6-4b1b-95f4-bdbbcea481be"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Confirm Dispensation Not Found Response":{
"description":"Confirm Dispensation Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Dispensation confirmed already for this kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Confirm Dispensation Bad Request Response":{
"description":"Confirm Dispensation Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Confirm Dispensation Server Error Response":{
"description":"Confirm Dispensation Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{kitId}-confirmDispensation-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-kitid-confirmdispensation-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kitlists/{listId}/disable":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Disable kit list with inventories"
],
"summary":"v1.0",
"description":"Disables kit list. Rights: BarCodePost.",
"operationId":"disableKitlist",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"listId",
"in":"path",
"description":"Kit list ID",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Disable Kit List Response":{
"description":"Disable Kit List Response",
"value":{
"status":"SUCCESS",
"result":null,
"errorData":null
}
}
}
}
}
},
"404":{
"description":"Invalid study ID OR Study not found OR Kit list not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Disable Kit List Not Found Response":{
"description":"Disable Kit List Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Kit list",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Disable Kit List Bad Request Response":{
"description":"Disable Kit List Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Disable Kit List Server Error Response":{
"description":"Disable Kit List Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kitlists-{listId}-disable-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kitlists-listid-disable-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/generate":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Generate kits"
],
"summary":"v1.0",
"description":"Generates kits. Rights: DesignerKitListPost.",
"operationId":"generateKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Kit attribute parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateKitsRequest"
},
"examples":{
"Generate Kits Request":{
"description":"Generate Kits Request",
"value":{
"title":"Comparative Cream - Batch B",
"description":"Initial kit generation for the study",
"kitTypes":[
{
"id":"b1b8327a-faa6-4122-8710-6192ab5984ef",
"quantity":10
}
],
"kitNumberStart":1001,
"sequenceNumberStart":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateKitsResponse"
},
"examples":{
"Generate Kits Response":{
"description":"Generate Kits Response",
"value":{
"inventorySourceId":"B1B8327AFAA6412287106192AB5984EF",
"noOfKitsGenerated":10
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Generate Kits Not Found Response":{
"description":"Generate Kits Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"The title has already been used OR Invalid kit type OR The maximum number of rows requested shall not exceed 500000 OR Some numbers in this list are used in another kit list. Adjust the first kit or sequence number so that the values don't overlap with existing numbers. OR 1 or more sequence numbers already exist OR 1 or more kit numbers already exist OR The CSV might contain duplicate kit number(s) or sequence number(s)",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Generate Kits Bad Request Response":{
"description":"Generate Kits Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Generate Kits Server Error Response":{
"description":"Generate Kits Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-generate-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-generate-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventorystatuses/allowed/{fromInventoryStatusId}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get allowed inventory statuses"
],
"summary":"v1.0",
"description":"Retrieves allowed inventory statuses. Rights: OrsInventoryGet.",
"operationId":"getAllowedInventoryStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"fromInventoryStatusId",
"in":"path",
"description":"ID of the initial inventory status in status transition.",
"required":true,
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Allowed Inventory Statuses Response":{
"description":"Get Allowed Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":2,
"inventoryStatus":"Damaged"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Allowed Inventory Statuses Server Error Response":{
"description":"Get Allowed Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventorystatuses-allowed-{fromInventoryStatusId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventorystatuses-allowed-frominventorystatusid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventorystatuses/cancelledshipment":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get cancelled inventory statuses"
],
"summary":"v1.0",
"description":"Retrieves an inventory's cancelled status. Rights: OrsInventoryGet.",
"operationId":"getCancelledInventoryStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Cancelled Inventory Statuses Response":{
"description":"Get Cancelled Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":8,
"inventoryStatus":"In Transit"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Cancelled Inventory Statuses Server Error Response":{
"description":"Get Cancelled Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventorystatuses-cancelledshipment-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventorystatuses-cancelledshipment-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventorystatuses/destruction":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get destruction inventory statuses"
],
"summary":"v1.0",
"description":"Retrieves destruction-related statuses from the inventory. Rights: OrsInventoryGet.",
"operationId":"getDestructionInventoryStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Destruction Inventory Statuses Response":{
"description":"Get Destruction Inventory Statuses Response",
"value":[
{
"inventoryStatusId":11,
"inventoryStatus":"Pending Destruction"
},
{
"inventoryStatusId":20,
"inventoryStatus":"Received for Destruction"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Destruction Inventory Statuses Server Error Response":{
"description":"Get Destruction Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventorystatuses-destruction-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventorystatuses-destruction-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kits/{inventoryId}/dispensation":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get dispensation details by inventory ID"
],
"summary":"v1.0",
"description":"Retrieves dispensation details like subject source ID, visit source ID and instance number for a given inventory ID. Rights: OrsInventoryGet.",
"operationId":"getInventoryDispensation",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryDispensationResponseV1"
},
"examples":{
"Get Inventory Dispensation Response":{
"description":"Get Inventory Dispensation Response",
"value":{
"subjectSrcId":"B1B8327AFAA6412287106192AB5984EF",
"visitSrcId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"instanceNumber":1,
"kitNumber":1001
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory Dispensation Server Error Response":{
"description":"Get Inventory Dispensation Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory Dispensation Not Found Response":{
"description":"Get Inventory Dispensation Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kits-{inventoryId}-dispensation-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kits-inventoryid-dispensation-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventorystatuses":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get inventory statuses"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves statuses from an inventory. Rights: OrsInventoryGet.",
"operationId":"getInventoryStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Inventory Statuses Response":{
"description":"Get Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":8,
"inventoryStatus":"In Transit"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory Statuses Server Error Response":{
"description":"Get Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventorystatuses-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventorystatuses-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/{kitId}/barcode":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get a kit's barcode by kit ID"
],
"summary":"v1.0",
"description":"Retrieves a kit's barcode. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitBarcode",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID",
"required":true,
"schema":{
"type":"string"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitBarcodeTO"
},
"examples":{
"Get Kit Barcode Response":{
"description":"Get Kit Barcode Response",
"value":{
"barcode":"61234"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Barcode Not Found Response":{
"description":"Get Kit Barcode Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Inventory Status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Barcode Bad Request Response":{
"description":"Get Kit Barcode Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Barcode Server Error Response":{
"description":"Get Kit Barcode Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{kitId}-barcode-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-kitid-barcode-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update a kit's barcode"
],
"summary":"v1.0",
"description":"Updates a kit's barcode by kit ID. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKitBarcode",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID",
"required":true,
"schema":{
"type":"string"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"requestBody":{
"description":"Kit label group parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitBarcodeTO"
},
"examples":{
"Update Kit Barcode Request":{
"description":"Update Kit Barcode Request",
"value":{
"barcode":"61234"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitBarcodeTO"
},
"examples":{
"Update Kit Barcode Response":{
"description":"Update Kit Barcode Response",
"value":{
"barcode":"61234"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Barcode Not Found Response":{
"description":"Update Kit Barcode Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Inventory Status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Barcode Bad Request Response":{
"description":"Update Kit Barcode Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Barcode Server Error Response":{
"description":"Update Kit Barcode Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{kitId}-barcode-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-kitid-barcode-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kitDetails":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit details by kit number"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves kit details by kit number. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitByKitNumber",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitInfoResponse"
},
"examples":{
"Get Kit By Kit Number Response":{
"description":"Get Kit By Kit Number Response",
"value":{
"kitDetails":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"manufacturingLotId":"LOT-001",
"labelGroupId":"LABEL-001",
"inventoryStatus":"Available"
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Not Found Response":{
"description":"Get Kit By Kit Number Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Bad Request Response":{
"description":"Get Kit By Kit Number Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid kit number.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Server Error Response":{
"description":"Get Kit By Kit Number Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kitDetails-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kitdetails-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/{kitNumber}/lastStatus":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get a kit's last status by kit number"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a kit's last status by kit number. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitLastStatus",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitNumber",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"number"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusResponse"
},
"examples":{
"Get Kit Last Status Response":{
"description":"Get Kit Last Status Response",
"value":{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status Not Found Response":{
"description":"Get Kit Last Status Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Inventory Status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status Bad Request Response":{
"description":"Get Kit Last Status Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid kit number.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status Server Error Response":{
"description":"Get Kit Last Status Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{kitNumber}-lastStatus-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-kitnumber-laststatus-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/{inventoryId}/lastStatusById":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get a kit's last status"
],
"summary":"v1.0",
"description":"Retrieves a kit's last status by inventory ID. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitLastStatusById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusResponse"
},
"examples":{
"Get Kit Last Status By ID Response":{
"description":"Get Kit Last Status By ID Response",
"value":{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By ID Not Found Response":{
"description":"Get Kit Last Status By ID Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Inventory Status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By ID Bad Request Response":{
"description":"Get Kit Last Status By ID Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By ID Server Error Response":{
"description":"Get Kit Last Status By ID Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{inventoryId}-lastStatusById-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-inventoryid-laststatusbyid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kitlists":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit list details"
],
"summary":"v1.0",
"description":"Retrieves generated/uploaded kit lists details in a study. Rights: OrsInventoryGet.",
"operationId":"getKitListsDetails",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitListDetailsTOV1"
}
},
"examples":{
"Get Kit Lists Details Response":{
"description":"Get Kit Lists Details Response",
"value":[
{
"id":"b1b8327a-faa6-4122-8710-6192ab5984ef",
"name":"KitList-01",
"description":"Initial kit list upload",
"statusId":1
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Lists Details Server Error Response":{
"description":"Get Kit Lists Details Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kitlists-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kitlists-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kits/audit":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Kit list details for each kit"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Kit list details of each kit. Rights: OrsInventoryGet.",
"operationId":"getKitsAudit",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"required":true,
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"required":true,
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
},
{
"name":"inventorySourceId",
"in":"query",
"schema":{
"type":"string"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditRequestV1"
},
"examples":{
"Kits Audit Request":{
"description":"Kits Audit Request",
"value":{
"kits":[
"b1b8327a-faa6-4122-8710-6192ab5984ef"
]
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditResponseV1"
}
}
}
},
"404":{
"description":"Invalid study ID OR Study not found OR Inventory Source ID not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Not Found Response":{
"description":"Kits Audit Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Bad Request Response":{
"description":"Kits Audit Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Server Error Response":{
"description":"Kits Audit Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kits-audit-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kits-audit-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kit-types/{kitTypeId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary by kit type ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves kit summary by kit type ID. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitsByKitTypeId",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitTypeId",
"in":"path",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string"
},
"example":100
},
{
"name":"sortBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered. Default value is 'SEQUENCE_NUMBER'.",
"schema":{
"type":"string",
"default":"SEQUENCE_NUMBER"
},
"example":"SEQUENCE_NUMBER"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDetailsResponse"
},
"examples":{
"Get Kits By Kit Type ID Response":{
"description":"Get Kits By Kit Type ID Response",
"value":{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"minSequenceNumber":1,
"maxSequenceNumber":10,
"minKitNumber":1001,
"maxKitNumber":1010,
"kits":[
{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"inventoryStatus":"Available"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version or Kit type not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Not Found Response":{
"description":"Get Kits By Kit Type ID Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filtersOR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Bad Request Response":{
"description":"Get Kits By Kit Type ID Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Server Error Response":{
"description":"Get Kits By Kit Type ID Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kit-types-{kitTypeId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kit-types-kittypeid-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/suggested-max-numbers":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get max kit number"
],
"summary":"v1.0",
"description":"Retrieves the maximum number of kits. Rights: DesignerKitListGet.",
"operationId":"getMaxNumbers",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsMaxResponse"
},
"examples":{
"Get Suggested Max Numbers Response":{
"description":"Get Suggested Max Numbers Response",
"value":{
"suggestedKitNumber":1101,
"suggestedSequenceNumber":101
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Suggested Max Numbers Not Found Response":{
"description":"Get Suggested Max Numbers Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Suggested Max Numbers Server Error Response":{
"description":"Get Suggested Max Numbers Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-suggested-max-numbers-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-suggested-max-numbers-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/packagetypes":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get types of packages"
],
"summary":"v1.0",
"description":"Retrieves package type by study ID. Rights: OrsInventoryGet.",
"operationId":"getPackageTypes",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/PackageType"
}
},
"examples":{
"Get Package Types Response":{
"description":"Get Package Types Response",
"value":[
{
"packageTypeId":1,
"packageType":"BOTTLE"
},
{
"packageTypeId":2,
"packageType":"VIAL"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Package Types Server Error Response":{
"description":"Get Package Types Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-packagetypes-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-packagetypes-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kit-types/location/{locationId}/pendingdestructioncount":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get pending Destruction count by location ID"
],
"summary":"v1.0",
"description":"Retrieves pending destruction counts and kit type source ID available at location. Rights: OrsInventoryGet.",
"operationId":"getPendingDestructionCount",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"locationId",
"in":"path",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PendingDestructionKitCountResponseV1"
},
"examples":{
"Get Pending Destruction Count Response":{
"description":"Get Pending Destruction Count Response",
"value":{
"kitTypes":[
{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"count":12
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Pending Destruction Count Server Error Response":{
"description":"Get Pending Destruction Count Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Pending Destruction Count Not Found Response":{
"description":"Get Pending Destruction Count Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kit-types-location-{locationId}-pendingdestructioncount-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kit-types-location-locationid-pendingdestructioncount-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/qualified-kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get list of filtered kits"
],
"summary":"v1.0",
"description":"Retrieves list of kits which had qualified recent updates based on criteria defined by Oracle Clinical One Integration Hub. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getQualifiedKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"startDate",
"in":"query",
"description":"Start date/time for retrieving qualified kit updates",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01T00:00:00.000Z"
},
{
"name":"endDate",
"in":"query",
"description":"End date/time for retrieving qualified kit updates",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-29T23:59:59.999Z"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDetailsExtTO"
}
},
"examples":{
"Get Qualified Kits Response":{
"description":"Get Qualified Kits Response",
"value":[
{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"inventoryStatus":"Available",
"blockNumber":"BLK-01",
"kitNumberUTF":"KIT-1001"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Qualified Kits Not Found Response":{
"description":"Get Qualified Kits Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid date range",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Qualified Kits Bad Request Response":{
"description":"Get Qualified Kits Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid date range.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Qualified Kits Server Error Response":{
"description":"Get Qualified Kits Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-qualified-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-qualified-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventorystatuses/receivedshipment":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get received inventory statuses"
],
"summary":"v1.0",
"description":"Retrieves received inventory status. Rights: OrsInventoryGet.",
"operationId":"getReceivedInventoryStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Received Inventory Statuses Response":{
"description":"Get Received Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":20,
"inventoryStatus":"Received for Destruction"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Received Inventory Statuses Server Error Response":{
"description":"Get Received Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventorystatuses-receivedshipment-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventorystatuses-receivedshipment-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/singlekitsettings":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get single kit settings"
],
"summary":"v1.0",
"description":"Retrieves single kit settings by study ID. Rights: OrsInventoryGet.",
"operationId":"getSingleKitSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SingleKitSetting"
}
},
"examples":{
"Get Single Kit Settings Response":{
"description":"Get Single Kit Settings Response",
"value":[
{
"singleKitSettingId":1,
"singleKitSetting":"DISPENSE_SINGLE_KIT"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Single Kit Settings Server Error Response":{
"description":"Get Single Kit Settings Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-singlekitsettings-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-singlekitsettings-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/{kitNumber}/history":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history by KitNumberUTF"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a site's kit history. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getSiteKitHistory",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitNumber",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"number"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
}
},
"examples":{
"Get Site Kit History Response":{
"description":"Get Site Kit History Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available",
"reason":"Initial receipt",
"returnedUnits":0,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History Not Found Response":{
"description":"Get Site Kit History Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History Server Error Response":{
"description":"Get Site Kit History Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{kitNumber}-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-kitnumber-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/{inventoryId}/historyById":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history by ID"
],
"summary":"v1.0",
"description":"Retrieves a kit's history by ID. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getSiteKitHistoryById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
}
},
"examples":{
"Get Kit History By ID Response":{
"description":"Get Kit History By ID Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available",
"reason":"Kit received",
"returnedUnits":0,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By ID Not Found Response":{
"description":"Get Kit History By ID Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By ID Server Error Response":{
"description":"Get Kit History By ID Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-{inventoryId}-historyById-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-inventoryid-historybyid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventorystatuses/site":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get a site inventory's status"
],
"summary":"v1.0",
"description":"Retrieves a site inventory status by study ID. Rights: OrsInventoryGet.",
"operationId":"getSiteUserInventoryStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Site User Inventory Statuses Response":{
"description":"Get Site User Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":11,
"inventoryStatus":"Pending Destruction"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site User Inventory Statuses Not Found Response":{
"description":"Get Site User Inventory Statuses Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site User Inventory Statuses Server Error Response":{
"description":"Get Site User Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventorystatuses-site-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventorystatuses-site-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get sites"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves sites by study ID. Rights: OrsInventoryGet. DEPRECATED - use /ec-site-svc/rest/v2.0/studies/{studyId}/{mode}/sdfs/sdf/{sdfType}",
"operationId":"getSites",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SDFModel"
}
},
"examples":{
"Get Sites Response":{
"description":"Get Sites Response",
"value":[
{
"sdf":{
"id":"B1B8327A-FAA6-4122-8710-6192AB5984EF",
"name":"Site 101",
"status":"ACTIVE",
"sdfType":"Site",
"studyOrgId":"SITE-101"
},
"sdfPropertyList":[
{
"propertyName":"PIN",
"propertyValue":"101"
}
],
"sdfAddresses":[
{
"addressType":"PRIMARY",
"addressStreet1":"123 Main Street",
"addressCity":"Austin",
"addressStateOrProvOrCounty":"Texas",
"addressPostalcode":"78701",
"addressCountry":"USA",
"phone":"+1-512-555-0101",
"email":"site101@example.com"
}
]
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Sites Not Found Response":{
"description":"Get Sites Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No sites found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Sites Server Error Response":{
"description":"Get Sites Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/settings":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get study settings"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves the study settings for a given study and mode. Rights: OrsInventoryGet.",
"operationId":"getSupplySettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingResponse"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"studyIdentifier":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-02-21T08:43:01Z",
"initialShipments":{
"whenToSend":"AT_SITE_ACTIVATION",
"visitNumber":5
},
"resupplyType":[
{
"resupplyName":"Primary",
"resupplyType":"MINMAX"
}
],
"inventory":{
"daysToRun":{
"sunday":false,
"monday":true,
"tuesday":true,
"wednesday":true,
"thursday":true,
"friday":true,
"saturday":false
},
"timeToRun":{
"timeHour":2,
"timeMinute":30,
"timePeriod":"AM",
"timeZone":"UTC"
}
},
"kitOrdering":{
"allowed":"Y",
"blindingGroupsRequired":"Y",
"kitsToPreventUnblinding":"2",
"kitType":"BOTTLE"
},
"labelGroups":"LG-01",
"shippingGroups":"SG-01",
"consignment":{
"enableTemperatureExecursion":"N",
"notReceivedDaysToWaitBeforeSiteNotified":5,
"siteCanRequestManual":"Y"
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Supply Settings Server Error Response":{
"description":"Get Supply Settings Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-settings-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-settings-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/barcode":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update a barcode"
],
"summary":"v1.0",
"description":"Updates a kit's barcode. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateBarcodes",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Kits to be updated with barcodes.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitNumberBarcodeTOV1"
}
},
"examples":{
"Update Barcodes Request":{
"description":"Update Barcodes Request",
"value":[
{
"kitNumber":1001,
"barcode":"61234"
},
{
"kitNumber":1002,
"barcode":"61235"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryUpdatedTO"
},
"examples":{
"Update Barcodes Response":{
"description":"Update Barcodes Response",
"value":{
"inventoryUpdated":5
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Barcodes Not Found Response":{
"description":"Update Barcodes Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Inventory Status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Barcodes Bad Request Response":{
"description":"Update Barcodes Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Barcodes Server Error Response":{
"description":"Update Barcodes Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-barcode-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-barcode-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kits":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit attributes"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Updates kit attributes. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKitAttributes_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Kit attribute parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitAttributesRequestV1"
},
"examples":{
"Update Kit Attributes Request":{
"description":"Update Kit Attributes Request",
"value":{
"reason":"Inventory update",
"inventoryStatusId":1,
"labelGroupId":"LABEL-001",
"location":"SITE-001",
"manufacturingLotId":"LOT-001",
"kits":[
"b1b8327a-faa6-4122-8710-6192ab5984ef"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitsResponseV1"
},
"examples":{
"Update Kit Attributes Response":{
"description":"Update Kit Attributes Response",
"value":{
"noOfRowsUpdated":10
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Not Found Response":{
"description":"Update Kit Attributes Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Specify at least one kit attribute OR Reason is required OR Specify at least one filter. OR Either kits or kitFilters is required OR Invalid kit status OR Invalid kit range filter OR Invalid lot OR Invalid label group in kit filters OR Invalid kit type OR Invalid location OR No kits to update OR Update kits retrieved size exceeds maximum rows for update limit OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Bad Request Response":{
"description":"Update Kit Attributes Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Server Error Response":{
"description":"Update Kit Attributes Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kits/label-group":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit label group"
],
"summary":"v1.0",
"description":"Updates kit label group. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKitLabelGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Kit label group parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitLabelGroupRequest"
},
"examples":{
"Update Kit Label Group Request":{
"description":"Update Kit Label Group Request",
"value":{
"reason":"Assign kits to label group",
"labelGroupId":"b1b8327a-faa6-4122-8710-6192ab5984ef",
"kits":[
"9b83bfb4-8c5a-41c5-9775-e4d8d22d8b26"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Kit Label Group Response":{
"description":"Update Kit Label Group Response",
"value":{
"id":"1bc29b36-f5d6-4b1b-95f4-bdbbcea481be"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Label Group Not Found Response":{
"description":"Update Kit Label Group Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid label group ID OR Invalid location OR Specify at least one filter OR Either kits or kitFilters is required. OR Invalid kit OR Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Label Group Bad Request Response":{
"description":"Update Kit Label Group Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Label Group Server Error Response":{
"description":"Update Kit Label Group Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kits-label-group-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kits-label-group-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kits/location":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit location"
],
"summary":"v1.0",
"description":"Updates kit location. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKitLocation",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Kit location parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitLocationRequest"
},
"examples":{
"Update Kit Location Request":{
"description":"Update Kit Location Request",
"value":{
"reason":"Transfer kits to site",
"location":"b1b8327a-faa6-4122-8710-6192ab5984ef",
"kits":[
"9b83bfb4-8c5a-41c5-9775-e4d8d22d8b26"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Kit Location Response":{
"description":"Update Kit Location Response",
"value":{
"id":"1bc29b36-f5d6-4b1b-95f4-bdbbcea481be"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Location Not Found Response":{
"description":"Update Kit Location Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid location OR Specify at least one filter OR Either kits or kitFilters is required. OR Invalid kit OR Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Location Bad Request Response":{
"description":"Update Kit Location Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Location Server Error Response":{
"description":"Update Kit Location Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kits-location-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kits-location-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kits/manufacturing-lot":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit manufacturing lot"
],
"summary":"v1.0",
"description":"Updates the kit's manufacturing lot. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"updateKitManufacturingLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Kit attribute parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitAttributesRequestV1"
},
"examples":{
"Update Kit Manufacturing Lot Request":{
"description":"Update Kit Manufacturing Lot Request",
"value":{
"reason":"Move kits to the current manufacturing lot",
"manufacturingLotId":"LOT-001",
"kits":[
"b1b8327a-faa6-4122-8710-6192ab5984ef"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Kit Manufacturing Lot Response":{
"description":"Update Kit Manufacturing Lot Response",
"value":{
"id":"1bc29b36-f5d6-4b1b-95f4-bdbbcea481be"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Kit type not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Manufacturing Lot Not Found Response":{
"description":"Update Kit Manufacturing Lot Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location OR You can update up to 5,000 kits at one time. Please update the kits in smaller groups OR No kits to update OR All kits should have same inventory status OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Manufacturing Lot Bad Request Response":{
"description":"Update Kit Manufacturing Lot Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Manufacturing Lot Server Error Response":{
"description":"Update Kit Manufacturing Lot Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kits-manufacturing-lot-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kits-manufacturing-lot-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/inventory/kits/status":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit status"
],
"summary":"v1.0",
"description":"Updates kit status. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Kit status parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitStatusRequestV1"
},
"examples":{
"Update Kits Status Request":{
"description":"Update Kits Status Request",
"value":{
"reason":"Damaged during transit",
"inventoryStatusId":2,
"kits":[
"b1b8327a-faa6-4122-8710-6192ab5984ef"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Kits Status Response":{
"description":"Update Kits Status Response",
"value":{
"id":"1bc29b36-f5d6-4b1b-95f4-bdbbcea481be"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Status Not Found Response":{
"description":"Update Kits Status Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit OR Specify at least one filter OR Either kits or kitFilters is required OR Invalid Inventory Status OR All kits should have same inventory status OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Status Bad Request Response":{
"description":"Update Kits Status Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Status Server Error Response":{
"description":"Update Kits Status Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-inventory-kits-status-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-inventory-kits-status-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitNumber}/lastStatus":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get latest status of kit in site inventory"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves the latest status of a kit at a site. Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getKitLastStatus_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitNumber",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"number"
},
"example":10001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusResponse"
},
"examples":{
"Get Kit Last Status By Kit Number Response":{
"description":"Get Kit Last Status By Kit Number Response",
"value":{
"inventoryStatusId":10,
"inventoryStatus":"Dispensed"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By Kit Number Server Error Response":{
"description":"Get Kit Last Status By Kit Number Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving the kit status."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By Kit Number Not Found Response":{
"description":"Get Kit Last Status By Kit Number Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The site kit was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By Kit Number Bad Request Response":{
"description":"Get Kit Last Status By Kit Number Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit number is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitNumber}-lastStatus-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-inventory-kits-kitnumber-laststatus-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{inventoryId}/lastStatusById":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get latest status of kit in site inventory by ID"
],
"summary":"v1.0",
"description":"Retrieves the latest status of a kit at a site. Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getKitLastStatusById_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusResponse"
},
"examples":{
"Get Kit Last Status By Inventory ID Response":{
"description":"Get Kit Last Status By Inventory ID Response",
"value":{
"inventoryStatusId":10,
"inventoryStatus":"Dispensed"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By Inventory ID Server Error Response":{
"description":"Get Kit Last Status By Inventory ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving the site kit status."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By Inventory ID Not Found Response":{
"description":"Get Kit Last Status By Inventory ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The site inventory record was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Last Status By Inventory ID Bad Request Response":{
"description":"Get Kit Last Status By Inventory ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site inventory identifier is invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{inventoryId}-lastStatusById-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-inventory-kits-inventoryid-laststatusbyid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitNumber}/history":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history by kit number for a site"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Retrieves a kit's history at a site by kit number. Rights: OrsInventoryGet and OrsBlinded.",
"operationId":"getSiteKitHistory_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitNumber",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"number"
},
"example":10001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
},
"examples":{
"Get Kit History By Kit Number Response":{
"description":"Get Kit History By Kit Number Response",
"value":{
"inventoryStatusId":5,
"inventoryStatus":"Available",
"reason":"Status updated during reconciliation",
"returnedUnits":10,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By Kit Number Server Error Response":{
"description":"Get Kit History By Kit Number Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kit history."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By Kit Number Not Found Response":{
"description":"Get Kit History By Kit Number Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kit history was found for the provided kit number."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By Kit Number Bad Request Response":{
"description":"Get Kit History By Kit Number Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit number is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitNumber}-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-inventory-kits-kitnumber-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{inventoryId}/historyById":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history for a site by kitNumberUTF"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a kit's history at a site by inventory ID. Rights: OrsInventoryGet and OrsBlinded.",
"operationId":"getSiteKitHistoryById_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
},
"examples":{
"Get Kit History By Inventory ID Response":{
"description":"Get Kit History By Inventory ID Response",
"value":{
"inventoryStatusId":5,
"inventoryStatus":"Available",
"reason":"Status updated during reconciliation",
"returnedUnits":10,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By Inventory ID Server Error Response":{
"description":"Get Kit History By Inventory ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kit history."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By Inventory ID Not Found Response":{
"description":"Get Kit History By Inventory ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kit history was found for the provided inventory identifier."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit History By Inventory ID Bad Request Response":{
"description":"Get Kit History By Inventory ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site inventory identifier is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{inventoryId}-historyById-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-inventory-kits-inventoryid-historybyid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Retrieves kits for a site based on search criteria like range and status. Rights: OrsInventoryGet and OrsBlinded.",
"operationId":"getSiteKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"searchString",
"in":"query",
"schema":{
"type":"string"
}
},
{
"name":"kitRange",
"in":"query",
"schema":{
"type":"string"
}
},
{
"name":"offset",
"in":"query",
"schema":{
"type":"string",
"default":"0"
}
},
{
"name":"limit",
"in":"query",
"schema":{
"type":"string",
"default":"100"
}
},
{
"name":"inventoryStatusId",
"in":"query",
"schema":{
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponse"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"minKitNumber":10001,
"maxKitNumber":10100,
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Server Error Response":{
"description":"Get Site Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kits."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitId}":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit status by kit ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Updates a kit's status at a site by kit ID. Rights: OrsInventoryPost and OrsBlinded.",
"operationId":"updateKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitId",
"in":"path",
"description":"ID of the kit.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Kit status update details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitStatusRequest"
},
"examples":{
"Update Site Kit Status Request":{
"description":"Update Site Kit Status Request",
"value":{
"inventoryStatusId":10,
"subjectId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Kit damaged by subject"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Site Kit Status Response":{
"description":"Update Site Kit Status Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Site Kit Status Server Error Response":{
"description":"Update Site Kit Status Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating the site kit status."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitId}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-inventory-kits-kitid-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitId}/verify":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Set kit verification status"
],
"summary":"v1.0",
"description":"Sets a kit's verification status. Rights: OrsInventoryPost and either OrsUnblinded or SourceDataVerification.",
"operationId":"verifyKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitId",
"in":"path",
"description":"ID of the kit.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Kit verification status.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserVerifyKitRequest"
},
"examples":{
"Verify Kit Request":{
"description":"Verify Kit Request",
"value":{
"verified":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Verify Kit Response":{
"description":"Verify Kit Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Verify Kit Server Error Response":{
"description":"Verify Kit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while verifying the site kit."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Verify Kit Not Found Response":{
"description":"Verify Kit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The site kit was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Verify Kit Bad Request Response":{
"description":"Verify Kit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The kit verification request is invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitId}-verify-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-inventory-kits-kitid-verify-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/upload/file/{fileId}":{
"delete":{
"tags":[
"Randomization and Supplies/Inventory APIs/Delete kit list file"
],
"summary":"v1.0",
"description":"Removes kit list files. Rights: DesignerKitListUpload.",
"operationId":"deleteRndListFile",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"fileId",
"in":"path",
"description":"ID of the file.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Delete Uploaded Inventory File Response":{
"description":"Delete Uploaded Inventory File Response",
"value":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
},
"404":{
"description":"Invalid study ID
Invalid file identifier",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Uploaded Inventory File Not Found Response":{
"description":"Delete Uploaded Inventory File Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The uploaded inventory file was not found.",
"details":{
"field":"fileId",
"reason":"No uploaded inventory file matched the supplied file identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit list file ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Uploaded Inventory File Bad Request Response":{
"description":"Delete Uploaded Inventory File Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The uploaded inventory file cannot be deleted.",
"details":{
"field":"fileId",
"reason":"The associated kit list already has inventories and cannot be removed."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Uploaded Inventory File Server Error Response":{
"description":"Delete Uploaded Inventory File Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while deleting the uploaded inventory file.",
"details":{
"operation":"deleteUploadedInventoryFile",
"reason":"The inventory file could not be removed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-upload-file-{fileId}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-upload-file-fileid-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/upload/{fileId}/fileheaders":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Parse file headers"
],
"summary":"v1.0",
"description":"Parses file headers. Rights: DesignerKitListUpload.",
"operationId":"processFileHeaders",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"containsHeadersRow",
"in":"query",
"description":"Specify whether the headers row is included. Default value is 'y'.",
"schema":{
"type":"string",
"default":"y"
},
"example":"y"
},
{
"name":"fileId",
"in":"path",
"description":"ID of the file.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UploadCSVHeaderResponse"
},
"examples":{
"Process File Headers Response":{
"description":"Process File Headers Response",
"value":{
"headers":[
"Kit Number",
"Kit Type",
"Lot Number"
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID
Invalid file identifier",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Process File Headers Not Found Response":{
"description":"Process File Headers Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The uploaded inventory file was not found.",
"details":{
"field":"fileId",
"reason":"No uploaded inventory file matched the supplied file identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid CSV file format or data",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Process File Headers Bad Request Response":{
"description":"Process File Headers Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The file header row could not be parsed.",
"details":{
"field":"containsHeadersRow",
"reason":"Use y or n and ensure the uploaded file has a readable header row."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Process File Headers Server Error Response":{
"description":"Process File Headers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while reading inventory file headers.",
"details":{
"operation":"processFileHeaders",
"reason":"The inventory file headers could not be read."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-upload-{fileId}-fileheaders-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-upload-fileid-fileheaders-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/upload/kittypesfromfile":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Upload kit types data"
],
"summary":"v1.0",
"description":"Uploads kit types data. Rights: DesignerKitListUpload.",
"operationId":"processKitTypesFromFile",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryUploadRequest"
},
"examples":{
"Process Kit Types From File Request":{
"description":"Process Kit Types From File Request",
"value":{
"fileId":"B1B8327AFAA6412287106192AB5984EF",
"containsHeadersRow":"y",
"headerMappings":[
{
"fileHeader":"Kit Type",
"dbHeader":"KIT_TYPE"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InvUploadKitTypeResponse"
},
"examples":{
"Process Kit Types From File Response":{
"description":"Process Kit Types From File Response",
"value":{
"kitTypes":[
"KITTYPE-A",
"KITTYPE-B"
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID
Invalid file identifier",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Process Kit Types From File Not Found Response":{
"description":"Process Kit Types From File Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The uploaded inventory file was not found.",
"details":{
"field":"fileId",
"reason":"No uploaded inventory file matched the supplied file identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid CSV file format, data, or header mappings",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Process Kit Types From File Invalid Header Mappings Response":{
"description":"Process Kit Types From File Invalid Header Mappings Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"Header mappings are invalid for the uploaded inventory file.",
"details":{
"field":"headerMappings",
"reason":"Provide a unique mapping for the Kit Type column that exists in the uploaded file."
}
}
}
},
"Process Kit Types From File Invalid CSV Content Response":{
"description":"Process Kit Types From File Invalid CSV Content Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The inventory file content is invalid.",
"details":{
"field":"fileId",
"reason":"The file contains empty rows, empty cells, or unsupported characters."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Process Kit Types From File Server Error Response":{
"description":"Process Kit Types From File Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while processing kit types from the inventory file.",
"details":{
"operation":"processKitTypesFromFile",
"reason":"The inventory file could not be analyzed for kit type values."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-upload-kittypesfromfile-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-upload-kittypesfromfile-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/upload/uploadfile":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Upload kit list file"
],
"summary":"v1.0",
"description":"Uploads kit list file. Rights: DesignerKitListUpload.",
"operationId":"uploadFile",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FileUploadRequest"
},
"examples":{
"Upload Inventory CSV File Request":{
"description":"Upload Inventory CSV File Request",
"value":{
"name":"Inventory CSV Upload",
"description":"Initial inventory upload for site kits",
"mode":"test",
"fileName":"inventory_upload.csv"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FileUploadResponse"
},
"examples":{
"Upload Inventory CSV File Response":{
"description":"Upload Inventory CSV File Response",
"value":{
"fileId":"7074779C195A4BF2B5EB0CEFB34BD47F"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID
Invalid file identifier",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Inventory CSV File Not Found Response":{
"description":"Upload Inventory CSV File Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The source file was not found.",
"details":{
"field":"fileName",
"reason":"No file in the file service matched the supplied file name."
}
}
}
}
}
}
}
},
"400":{
"description":"Duplicate kit list title",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Inventory CSV File Duplicate Title Response":{
"description":"Upload Inventory CSV File Duplicate Title Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The kit list title already exists.",
"details":{
"field":"name",
"reason":"Use a unique kit list name for this study."
}
}
}
},
"Upload Inventory CSV File Invalid Metadata Response":{
"description":"Upload Inventory CSV File Invalid Metadata Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The file metadata is invalid for inventory upload.",
"details":{
"field":"fileName",
"reason":"Provide a valid uploaded file name and a non-blank kit list name."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Inventory CSV File Server Error Response":{
"description":"Upload Inventory CSV File Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while uploading the inventory file.",
"details":{
"operation":"uploadInventoryFile",
"reason":"The inventory source or file record could not be created."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-upload-uploadfile-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-upload-uploadfile-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/upload/uploadinventory":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Upload inventory data as CSV file"
],
"summary":"v1.0",
"description":"Uploads inventory data as a CSV file. Rights: DesignerKitListUpload.",
"operationId":"uploadInventoryList",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryUploadRequest"
},
"examples":{
"Upload Inventory List Request":{
"description":"Upload Inventory List Request",
"value":{
"fileId":"B1B8327AFAA6412287106192AB5984EF",
"containsHeadersRow":"y",
"headerMappings":[
{
"fileHeader":"Kit Number",
"dbHeader":"KIT_NUMBER"
},
{
"fileHeader":"Kit Type",
"dbHeader":"KIT_TYPE"
},
{
"fileHeader":"Sequence Number",
"dbHeader":"SEQUENCE_NUMBER"
}
],
"kitTypeMappings":[
{
"kitFromFile":"KITTYPE-A",
"kitTypeId":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"kitFromFile":"KITTYPE-B",
"kitTypeId":"89EE76326E984B548D594D592E5C7FC2"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateKitsResponse"
},
"examples":{
"Upload Inventory List Response":{
"description":"Upload Inventory List Response",
"value":{
"inventorySourceId":"B1B8327AFAA6412287106192AB5984EF",
"noOfKitsGenerated":10
}
}
}
}
}
},
"404":{
"description":"Invalid study ID
Invalid file identifier",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Inventory List Not Found Response":{
"description":"Upload Inventory List Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The uploaded inventory file was not found.",
"details":{
"field":"fileId",
"reason":"No uploaded inventory file matched the supplied file identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid CSV file format or data",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Inventory List Invalid Header Mappings Response":{
"description":"Upload Inventory List Invalid Header Mappings Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"Header mappings are invalid for the uploaded inventory file.",
"details":{
"field":"headerMappings",
"reason":"Provide unique mappings for Kit Number, Kit Type, and Sequence Number that match headers in the uploaded file."
}
}
}
},
"Upload Inventory List Invalid Kit Type Mappings Response":{
"description":"Upload Inventory List Invalid Kit Type Mappings Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"Kit type mappings are invalid for the uploaded inventory file.",
"details":{
"field":"kitTypeMappings",
"reason":"Each kit type from the file must map to a unique valid study kit type."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Inventory List Error Response":{
"description":"Upload Inventory List Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while uploading inventory data.",
"details":{
"operation":"uploadInventoryList",
"reason":"The inventory file could not be processed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-upload-uploadinventory-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-upload-uploadinventory-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit types"
],
"summary":"v1.0",
"description":"Retrieves kit types by study ID. Rights: OrsInventoryGet.",
"operationId":"getKitTypes",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/KitTypesResponse"
},
"examples":{
"Get Kit Types Response":{
"description":"Get Kit Types Response",
"value":{
"status":"success",
"result":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non-Dosing",
"packageTypeId":5
}
],
"errorData":null,
"version":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Types Server Error Response":{
"description":"Get Kit Types Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving kit types.",
"details":{
"operation":"getKitTypes",
"reason":"The kit types could not be loaded."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kit-types-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/label-groups":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get label groups"
],
"summary":"v1.0",
"description":"Retrieves label groups by study ID. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getAllLabelGroups",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/LabelGroup"
}
},
"examples":{
"Label groups list":{
"description":"Label groups list",
"value":[
{
"id":"8ECE2C9D389645B09740DC7926DEFB69",
"name":"US Labels",
"countries":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"United States"
}
]
}
]
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Label Groups Forbidden Response":{
"description":"Get All Label Groups Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view label groups.",
"details":{
"right":"OrsInventoryGet",
"reason":"The current user does not have access to unblinded label group data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Label Groups Server Error Response":{
"description":"Get All Label Groups Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-500",
"errorMessage":"Unexpected error while retrieving label groups.",
"details":{
"operation":"getAllLabelGroups",
"reason":"The label group lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-label-groups-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-label-groups-get"
},
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create label groups"
],
"summary":"v1.0",
"description":"Creates label groups by study ID. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"createLabelGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"requestBody":{
"description":"Label group request param.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LabelGroupRequest"
},
"examples":{
"Create label group request":{
"description":"Create label group request",
"value":{
"name":"US Labels",
"countries":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Created label group id":{
"description":"Created label group id",
"value":{
"id":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Label Group Forbidden Response":{
"description":"Create Label Group Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to create label groups.",
"details":{
"right":"OrsInventoryPost",
"reason":"The current user does not have create access for unblinded label group data."
}
}
}
}
}
}
}
},
"400":{
"description":"Label group already exists. OR Country does not exist in the system.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Label Group Bad Request Response":{
"description":"Create Label Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-400",
"errorMessage":"The label group request is invalid.",
"details":{
"field":"countries",
"reason":"At least one valid country identifier must be supplied."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Label Group Server Error Response":{
"description":"Create Label Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-500",
"errorMessage":"Unexpected error while creating the label group.",
"details":{
"operation":"createLabelGroup",
"reason":"The label group could not be created."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-label-groups-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-label-groups-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/label-groups/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get label groups by ID"
],
"summary":"v1.0",
"description":"Retrieves label groups by label group ID. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getLabelGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
},
{
"name":"id",
"in":"path",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LabelGroupResponse"
},
"examples":{
"Label group":{
"description":"Label group",
"value":{
"labelGroups":[
{
"id":"8ECE2C9D389645B09740DC7926DEFB69",
"name":"US Labels",
"countries":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"United States"
}
]
}
]
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Label Group Forbidden Response":{
"description":"Get Label Group Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view the label group.",
"details":{
"right":"OrsInventoryGet",
"reason":"The current user does not have access to unblinded label group data."
}
}
}
}
}
}
}
},
"404":{
"description":"Label group not found for study.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Label Group Not Found Response":{
"description":"Get Label Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-404",
"errorMessage":"The label group was not found.",
"details":{
"field":"id",
"reason":"The supplied label group identifier does not exist."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Label Group Server Error Response":{
"description":"Get Label Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-500",
"errorMessage":"Unexpected error while retrieving the label group.",
"details":{
"operation":"getLabelGroup",
"reason":"The label group lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-label-groups-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-label-groups-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update label groups"
],
"summary":"v1.0",
"description":"Updates label groups by study ID. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateLabelGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
},
{
"name":"id",
"in":"path",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"requestBody":{
"description":"Label group request param.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LabelGroupRequest"
},
"examples":{
"Update label group request":{
"description":"Update label group request",
"value":{
"name":"US Labels - Updated",
"countries":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Updated label group id":{
"description":"Updated label group id",
"value":{
"id":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Label Group Forbidden Response":{
"description":"Update Label Group Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to update label groups.",
"details":{
"right":"OrsInventoryPost",
"reason":"The current user does not have update access for unblinded label group data."
}
}
}
}
}
}
}
},
"400":{
"description":"Label group already exists. OR Country does not exist in the system.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Label Group Bad Request Response":{
"description":"Update Label Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-400",
"errorMessage":"The label group update request is invalid.",
"details":{
"field":"name",
"reason":"The label group name must be unique."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Label Group Server Error Response":{
"description":"Update Label Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-500",
"errorMessage":"Unexpected error while updating the label group.",
"details":{
"operation":"updateLabelGroup",
"reason":"The label group could not be updated."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-label-groups-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-label-groups-id-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Inventory APIs/Delete label groups"
],
"summary":"v1.0",
"description":"Removes label groups by label group ID. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"deleteLabelGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
},
{
"name":"id",
"in":"path",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Deleted label group id":{
"description":"Deleted label group id",
"value":{
"id":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Label Group Forbidden Response":{
"description":"Delete Label Group Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to delete label groups.",
"details":{
"right":"OrsInventoryDelete",
"reason":"The current user does not have delete access for unblinded label group data."
}
}
}
}
}
}
}
},
"400":{
"description":"Label group cannot be deleted as it has kits.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Label Group Bad Request Response":{
"description":"Delete Label Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-400",
"errorMessage":"The label group delete request is invalid.",
"details":{
"field":"id",
"reason":"The supplied label group identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Label Group Server Error Response":{
"description":"Delete Label Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LABEL-500",
"errorMessage":"Unexpected error while deleting the label group.",
"details":{
"operation":"deleteLabelGroup",
"reason":"The label group could not be deleted."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-label-groups-{id}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-label-groups-id-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/locally-sourced-kits":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Local Source Settings/Get all local source settings"
],
"summary":"v1.0",
"description":"Retrieves all locally sourced kit settings.",
"operationId":"getLocallySourcedKitSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ListResponseFactory"
},
"examples":{
"No local source settings":{
"description":"No local source settings",
"value":{
"status":"success",
"result":{
"message":"No local source settings were found for the study."
}
}
}
}
}
}
},
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LocalSourceSettingsResponse"
},
"examples":{
"Get Local Source Settings Response":{
"description":"Get Local Source Settings Response",
"value":{
"locallySourcedCountries":[
{
"localSourceId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"CREATE",
"objectVersionNumber":1,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Initial enablement.",
"comment":"Locally sourced kits enabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"B1C2D3E4F5064789A0B1C2D3E4F50647",
"enabled":true
}
],
"sourcedBySiteCountries":[
{
"localSourceId":"E0F1A2B3C4D567890123456789ABCDEF",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"CREATE",
"objectVersionNumber":1,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Initial enablement.",
"comment":"Sourced-by-site enabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"9ABCDEF01234567890123456789ABCDE",
"enabled":true
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ListResponseFactory"
},
"examples":{
"Get Local Source Settings Server Error Response":{
"description":"Get Local Source Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-500",
"errorMessage":"Unexpected error while retrieving local source settings.",
"details":{
"operation":"getLocallySourcedKitSettings",
"reason":"The local source settings lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-locally-sourced-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-locally-sourced-kits-get"
},
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Local Source Settings/Create local source settings for kit types"
],
"summary":"v1.0",
"description":"Creates local source settings for kit types.",
"operationId":"create_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Local Source Settings Request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LocalSourceSettingRequestV1"
},
"examples":{
"Create Local Source Setting Request":{
"description":"Create Local Source Setting Request",
"value":{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"locallySourcedCountries":[
"B1C2D3E4F5064789A0B1C2D3E4F50647"
],
"sourcedBySiteCountries":[
"9ABCDEF01234567890123456789ABCDE"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LocalSourceSettingsResponse"
},
"examples":{
"Create Local Source Setting Response":{
"description":"Create Local Source Setting Response",
"value":{
"locallySourcedCountries":[
{
"localSourceId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"CREATE",
"objectVersionNumber":1,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Initial enablement.",
"comment":"Locally sourced kits enabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"B1C2D3E4F5064789A0B1C2D3E4F50647",
"enabled":true
}
],
"sourcedBySiteCountries":[
{
"localSourceId":"E0F1A2B3C4D567890123456789ABCDEF",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"CREATE",
"objectVersionNumber":1,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Initial enablement.",
"comment":"Sourced-by-site enabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"9ABCDEF01234567890123456789ABCDE",
"enabled":true
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Local Source Setting Server Error Response":{
"description":"Create Local Source Setting Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-500",
"errorMessage":"Unexpected error while creating the local source setting.",
"details":{
"operation":"createLocalSourceSetting",
"reason":"The local source setting could not be created."
}
}
}
}
}
}
}
},
"404":{
"description":"For Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Local Source Setting Not Found Response":{
"description":"Create Local Source Setting Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-404",
"errorMessage":"The kit type was not found.",
"details":{
"field":"kitTypeSrcId",
"reason":"The supplied kit type identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"LocalSourceSettings Request is not valid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Local Source Setting Bad Request Response":{
"description":"Create Local Source Setting Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-400",
"errorMessage":"The local source setting request is invalid.",
"details":{
"field":"locallySourcedCountries",
"reason":"At least one country identifier must be provided."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-locally-sourced-kits-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-locally-sourced-kits-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/locally-sourced-kits/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Local Source Settings/Get local source settings by ID"
],
"summary":"v1.0",
"description":"Retrieves locally sourced kits settings by ID.",
"operationId":"getLocallySourcedKitSettingsById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"Local Source Settings ID parameter",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ListResponseFactory"
},
"examples":{
"No local source settings for kit type":{
"description":"No local source settings for kit type",
"value":{
"status":"success",
"result":{
"message":"No local source settings were found for the supplied kit type."
}
}
}
}
}
}
},
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LocalSourceSettingsResponse"
},
"examples":{
"Get Local Source Settings By Id Response":{
"description":"Get Local Source Settings By Id Response",
"value":{
"locallySourcedCountries":[
{
"localSourceId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"CREATE",
"objectVersionNumber":1,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Initial enablement.",
"comment":"Locally sourced kits enabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"B1C2D3E4F5064789A0B1C2D3E4F50647",
"enabled":true
}
],
"sourcedBySiteCountries":[
{
"localSourceId":"E0F1A2B3C4D567890123456789ABCDEF",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"CREATE",
"objectVersionNumber":1,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Initial enablement.",
"comment":"Sourced-by-site enabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"9ABCDEF01234567890123456789ABCDE",
"enabled":true
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ListResponseFactory"
},
"examples":{
"Get Local Source Settings By Id Server Error Response":{
"description":"Get Local Source Settings By Id Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-500",
"errorMessage":"Unexpected error while retrieving local source settings for the kit type.",
"details":{
"operation":"getLocallySourcedKitSettingsById",
"reason":"The local source settings lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-locally-sourced-kits-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-locally-sourced-kits-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Local Source Settings/Update local source settings by ID"
],
"summary":"v1.0",
"description":"Updates locally sourced kit settings by ID.",
"operationId":"updateLocalSourceSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"Local Source Settings ID parameter",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Local Source Settings Request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LocalSourceSettingUpdateRequestV1"
},
"examples":{
"Update Local Source Setting Request":{
"description":"Update Local Source Setting Request",
"value":{
"locallySourcedCountries":[
"B1C2D3E4F5064789A0B1C2D3E4F50647"
],
"sourcedBySiteCountries":[
"9ABCDEF01234567890123456789ABCDE"
],
"enabled":false
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LocalSourceSettingsResponse"
},
"examples":{
"Update Local Source Setting Response":{
"description":"Update Local Source Setting Response",
"value":{
"locallySourcedCountries":[
{
"localSourceId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"UPDATE",
"objectVersionNumber":2,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Settings update.",
"comment":"Locally sourced kits disabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"B1C2D3E4F5064789A0B1C2D3E4F50647",
"enabled":false
}
],
"sourcedBySiteCountries":[
{
"localSourceId":"E0F1A2B3C4D567890123456789ABCDEF",
"versionStart":"2026-01-10T09:15:00Z",
"versionEnd":"2026-12-31T23:59:59Z",
"operationType":"UPDATE",
"objectVersionNumber":2,
"userId":"6A1B2C3D4E5F67890123456789ABCDEF",
"reason":"Settings update.",
"comment":"Sourced-by-site remains enabled for the country.",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431F",
"countryId":"9ABCDEF01234567890123456789ABCDE",
"enabled":true
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Local Source Setting Server Error Response":{
"description":"Update Local Source Setting Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-500",
"errorMessage":"Unexpected error while updating the local source setting.",
"details":{
"operation":"updateLocalSourceSetting",
"reason":"The local source setting could not be updated."
}
}
}
}
}
}
}
},
"404":{
"description":"For Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Local Source Setting Not Found Response":{
"description":"Update Local Source Setting Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-404",
"errorMessage":"The local source setting was not found.",
"details":{
"field":"id",
"reason":"The supplied local source setting identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"LocalSourceSettings Request is not valid",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Local Source Setting Bad Request Response":{
"description":"Update Local Source Setting Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-400",
"errorMessage":"The local source setting update request is invalid.",
"details":{
"field":"enabled",
"reason":"The enabled flag must be provided for the update request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-locally-sourced-kits-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-locally-sourced-kits-id-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Settings APIs/Local Source Settings/Delete local source settings by ID"
],
"summary":"v1.0",
"description":"Removes locally sourced kit settings by ID.",
"operationId":"deleteLocalSourceSettingById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"Local Source Settings ID parameter",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Deleted local source setting id":{
"description":"Deleted local source setting id",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"400":{
"description":"For Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Local Source Setting Bad Request Response":{
"description":"Delete Local Source Setting Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOCAL-SOURCE-400",
"errorMessage":"The local source setting delete request is invalid.",
"details":{
"field":"id",
"reason":"The supplied local source setting identifier is not a valid UUID."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-locally-sourced-kits-{id}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-locally-sourced-kits-id-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/lots/manufacturing-lots":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get all manufacturing lots"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves all manufacturing lots by study ID. Rights: LotManagementGet.",
"operationId":"getAllManufacturingLots",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":25
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ManufacturingLotTOV1"
}
},
"examples":{
"Get Manufacturing Lots Response":{
"description":"Get Manufacturing Lots Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"manufacturingLotNumber":"MLOT-1001",
"expirationDate":"2026-12-31T00:00:00Z",
"blindedLotId":"0A1B2C3D4E5F67890123456789ABCDEF",
"doNotCount":5,
"doNotShip":10,
"lotNumber":"LOT-1001"
}
]
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lots Forbidden Response":{
"description":"Get Manufacturing Lots Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-403",
"errorMessage":"You do not have permission to view manufacturing lots.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lots Server Error Response":{
"description":"Get Manufacturing Lots Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-500",
"errorMessage":"Unexpected error while retrieving manufacturing lots.",
"details":{
"operation":"getAllManufacturingLots",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-manufacturing-lots-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-manufacturing-lots-get"
},
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create manufacturing lot"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Creates a manufacturing lot. Rights: LotManagementPost.",
"operationId":"createManufacturingLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"description":"Lot request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotRequestV1"
},
"examples":{
"Create manufacturing lot request":{
"description":"Create manufacturing lot request",
"value":{
"manufacturingLotNumber":"MLOT-1001",
"lotNumber":"LOT-1001",
"expirationDate":"2026-12-31",
"doNotShip":10,
"doNotCount":5
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotId"
},
"examples":{
"Created lot id":{
"description":"Created lot id",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Manufacturing Lot Forbidden Response":{
"description":"Create Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-403",
"errorMessage":"You do not have permission to create manufacturing lots.",
"details":{
"right":"LotManagementPost",
"reason":"The current user does not have create access for manufacturing lots."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid expiration date. OR Manufacturing Lot Number already exists or Lot short name (lotNumber) already exists.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Manufacturing Lot Bad Request Response":{
"description":"Create Manufacturing Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-400",
"errorMessage":"The manufacturing lot request is invalid.",
"details":{
"field":"manufacturingLotNumber",
"reason":"The manufacturing lot number is required."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Manufacturing Lot Server Error Response":{
"description":"Create Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-500",
"errorMessage":"Unexpected error while creating the manufacturing lot.",
"details":{
"operation":"createManufacturingLot",
"reason":"The manufacturing lot could not be created."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-manufacturing-lots-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-manufacturing-lots-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/lots/manufacturing-lots/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get manufacturing lot by ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves manufacturing lot by lot ID. Rights: LotManagementGet.",
"operationId":"getManufacturingLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManufacturingLotTOV1"
},
"examples":{
"Get Manufacturing Lot Response":{
"description":"Get Manufacturing Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"manufacturingLotNumber":"MLOT-1001",
"expirationDate":"2026-12-31T00:00:00Z",
"blindedLotId":"0A1B2C3D4E5F67890123456789ABCDEF",
"doNotCount":5,
"doNotShip":10,
"lotNumber":"LOT-1001"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lot Forbidden Response":{
"description":"Get Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-403",
"errorMessage":"You do not have permission to view the manufacturing lot.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lot Server Error Response":{
"description":"Get Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-500",
"errorMessage":"Unexpected error while retrieving the manufacturing lot.",
"details":{
"operation":"getManufacturingLot",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-manufacturing-lots-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update manufacturing lot by ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Update manufacturing lot by a lot's ID. Rights: LotManagementPost.",
"operationId":"updateManufacturingLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Lot request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotRequestV1"
},
"examples":{
"Update manufacturing lot request":{
"description":"Update manufacturing lot request",
"value":{
"manufacturingLotNumber":"MLOT-1001",
"lotNumber":"LOT-1001",
"expirationDate":"2027-06-30",
"doNotShip":15,
"doNotCount":3
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotId"
},
"examples":{
"Updated lot id":{
"description":"Updated lot id",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Manufacturing Lot Forbidden Response":{
"description":"Update Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-403",
"errorMessage":"You do not have permission to update manufacturing lots.",
"details":{
"right":"LotManagementPost",
"reason":"The current user does not have update access for manufacturing lots."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid expiration date. OR Manufacturing Lot Number already exists or Lot short name (lotNumber) already exists.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Manufacturing Lot Bad Request Response":{
"description":"Update Manufacturing Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-400",
"errorMessage":"The manufacturing lot update request is invalid.",
"details":{
"field":"expirationDate",
"reason":"The expiration date must be later than the current study date."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Manufacturing Lot Server Error Response":{
"description":"Update Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-500",
"errorMessage":"Unexpected error while updating the manufacturing lot.",
"details":{
"operation":"updateManufacturingLot",
"reason":"The manufacturing lot could not be updated."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-manufacturing-lots-id-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Inventory APIs/Delete manufacturing lot by ID"
],
"summary":"v1.0",
"description":"Removes a manufacturing lot by a lot's ID. Rights: LotManagementDelete.",
"operationId":"deleteManufacturingLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotId"
},
"examples":{
"Deleted lot id":{
"description":"Deleted lot id",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Manufacturing Lot Forbidden Response":{
"description":"Delete Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-403",
"errorMessage":"You do not have permission to delete manufacturing lots.",
"details":{
"right":"LotManagementDelete",
"reason":"The current user does not have delete access for manufacturing lots."
}
}
}
}
}
}
}
},
"404":{
"description":"Lot not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Manufacturing Lot Not Found Response":{
"description":"Delete Manufacturing Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-404",
"errorMessage":"The manufacturing lot was not found.",
"details":{
"field":"id",
"reason":"The supplied manufacturing lot identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"Either Lot belong to a blinded lot or is in use by one or more inventories",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Manufacturing Lot Bad Request Response":{
"description":"Delete Manufacturing Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-400",
"errorMessage":"The manufacturing lot delete request is invalid.",
"details":{
"field":"id",
"reason":"The supplied manufacturing lot identifier is not a valid UUID."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Manufacturing Lot Server Error Response":{
"description":"Delete Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-500",
"errorMessage":"Unexpected error while deleting the manufacturing lot.",
"details":{
"operation":"deleteManufacturingLot",
"reason":"The manufacturing lot could not be deleted."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lots-manufacturing-lots-id-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/lotsWithKits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get lots with kits"
],
"summary":"v1.0",
"description":"Retrieves lots with kits by study ID. Rights: LotManagementGet.",
"operationId":"getLotsWithKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"Lots with kits":{
"description":"Lots with kits",
"value":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Lots With Kits Forbidden Response":{
"description":"Get Lots With Kits Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-403",
"errorMessage":"You do not have permission to view lots with kits.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to lots-with-kits data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Lots With Kits Server Error Response":{
"description":"Get Lots With Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-500",
"errorMessage":"Unexpected error while retrieving lots with kits.",
"details":{
"operation":"getLotsWithKits",
"reason":"The lots-with-kits lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lotsWithKits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lotswithkits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/lotsbykittype/sdfs/{sdfType}/{sdfId}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit types by lots"
],
"summary":"v1.0",
"description":"Retrieves Kit Type by lot for the site. Rights: LotManagementGet.",
"operationId":"getManufacturingLotBySite",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"sdfType",
"in":"path",
"description":"Type of SDF: sites or depots.",
"required":true,
"schema":{
"type":"string"
},
"example":"site"
},
{
"name":"sdfId",
"in":"path",
"description":"Site ID.",
"required":true,
"schema":{
"type":"string"
},
"example":"A0B1C2D3E4F5064789A0B1C2D3E4F506"
},
{
"name":"srcDepotId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical depot",
"schema":{
"type":"string"
},
"example":"8C7A6B5D4E3F2109876543210ABCDEF0"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitLotDetailsTO"
},
"examples":{
"Kit types lots":{
"description":"Kit types lots",
"value":{
"kitTypes":[
{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"lots":[
{
"quantity":10,
"lotId":"1873CDF69E9B48B89B2D9E7951057D09",
"effectiveExpirationDate":"2027-12-31T00:00:00Z",
"lotName":"LOT-1001"
}
]
}
]
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Types By Lots By Site Forbidden Response":{
"description":"Get Kit Types By Lots By Site Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-403",
"errorMessage":"You do not have permission to view kit-type lot details.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to lot details by site."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Types By Lots By Site Server Error Response":{
"description":"Get Kit Types By Lots By Site Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"LOT-500",
"errorMessage":"Unexpected error while retrieving kit-type lot details.",
"details":{
"operation":"getManufacturingLotBySite",
"reason":"The lot details lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-lotsbykittype-sdfs-{sdfType}-{sdfId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-lotsbykittype-sdfs-sdftype-sdfid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/devices/{inventoryId}":{
"delete":{
"tags":[
"Randomization and Supplies/Device Management APIs/Deregister an mHealth device"
],
"summary":"v1.0",
"description":"Deregisters an mHealth device. Rights: DeviceActionsPost.",
"operationId":"deRegisterMHealthDevice",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0A1B2C3D4E5F67890123456789ABCDEF"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"mSubjectId",
"in":"query",
"description":"ID of the subject in mHealth.",
"required":true,
"schema":{
"type":"string"
},
"example":"MSUBJECT-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"De-registered":{
"description":"De-registered",
"value":"Device de-registered successfully."
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not found":{
"description":"Not found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DEVICE-404",
"errorMessage":"The study or requested version was not found.",
"details":{
"studyId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject ID OR Device is not dispensed to the subject OR Device is dispensed to different subject OR Invalid device ID OR mHealth device is not registered",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad request":{
"description":"Bad request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DEVICE-400",
"errorMessage":"The deregister mHealth device request is invalid.",
"details":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"The device is not registered for the specified subject."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error OR mHealth settings are not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server error":{
"description":"Server error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DEVICE-500",
"errorMessage":"An unexpected error occurred while deregistering the mHealth device.",
"details":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"mSubjectId":"MSUBJECT-001"
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-devices-{inventoryId}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-devices-inventoryid-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/devices/{inventoryId}/access-code":{
"put":{
"tags":[
"Randomization and Supplies/Device Management APIs/Recreate the access ID and one-time password for a bootstrap device"
],
"summary":"v1.0",
"description":"Recreates the access ID and OTP (one-time password) for a bootstrap device. Required if the password (OTP) has already expired. The device cannot be bootstrapped using expired or invalid credentials. Rights: DeviceActionsPost.",
"operationId":"refreshDeviceAccessIdPasswd",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"0A1B2C3D4E5F67890123456789ABCDEF"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"mSubjectId",
"in":"query",
"description":"ID of the subject in mHealth.",
"required":true,
"schema":{
"type":"string"
},
"example":"MSUBJECT-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BootStrapCredResponseDto"
},
"examples":{
"Refresh access code response":{
"description":"Refresh access code response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"accessId":"MHEALTH-ACCESS-002",
"otp":"OTP-654321"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not found":{
"description":"Not found",
"value":{
"status":"error"
}
}
}
}
}
},
"400":{
"description":"Invalid subject ID OR Device is not dispensed to the subject OR Device is dispensed to a different subject OR Invalid device ID OR mHealth device is not registered OR Device does not have any connection type OR Vendor code is missing for cloud-to-cloud connection type devices OR Device has a no-connection connection type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad request":{
"description":"Bad request",
"value":{
"status":"error"
}
}
}
}
}
},
"500":{
"description":"Internal server error OR mHealth settings are not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server error":{
"description":"Server error",
"value":{
"status":"error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-devices-{inventoryId}-access-code-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-devices-inventoryid-access-code-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/register-device":{
"post":{
"tags":[
"Randomization and Supplies/Device Management APIs/Register mHealth device"
],
"summary":"v1.0",
"description":"Registers an mHealth device. Rights: DeviceActionsPost.",
"operationId":"registerMHealthDevice",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string",
"example":"test"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"0A1B2C3D4E5F67890123456789ABCDEF"
}
],
"requestBody":{
"description":"Request object containing mHealth device registration details.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/MHealthRegisterDeviceRequest"
},
"examples":{
"Register mHealth device request":{
"description":"Register mHealth device request",
"value":{
"vendorCode":"VENDOR-XYZ",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"mSubjectId":"MSUBJECT-001",
"subjectNumber":"SITEA-0001"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BootStrapCredResponseDto"
},
"examples":{
"Register mHealth device response":{
"description":"Register mHealth device response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"accessId":"MHEALTH-ACCESS-001",
"otp":"OTP-123456"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not found":{
"description":"Not found",
"value":{
"status":"error"
}
}
}
}
}
},
"400":{
"description":"Invalid subject ID OR Device is not dispensed to the subject OR Device is dispensed to a different subject OR Invalid device ID OR Cloud-to-cloud connection type device is already registered OR Device does not have a connection type OR Vendor code is missing for cloud-to-cloud connection type devices OR Vendor code has been specified for device-to-cloud connection type devices OR Subject number is missing for device-to-cloud connection type devices OR Device has a no-connection connection type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad request":{
"description":"Bad request",
"value":{
"status":"error"
}
}
}
}
}
},
"500":{
"description":"Internal server error OR mHealth settings are not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server error":{
"description":"Server error",
"value":{
"status":"error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-register-device-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-register-device-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/nsinventory/lots/{lotId}":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Non-Serialized Kits APIs/Add quantity to lot for non-serialized kit types"
],
"summary":"v1.0",
"description":"Adds quantity for non-serialized kit types to lots.",
"operationId":"addQuantityToLot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"lotId",
"in":"path",
"description":"Lot ID",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Adds quantity to lot request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/NSAddQuantityToLotRequestV1"
},
"examples":{
"Add Non-Serialized Kit Quantity To Lot Request":{
"description":"Add Non-Serialized Kit Quantity To Lot Request",
"value":{
"kitTypes":[
{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"quantity":10
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryStatus"
},
"examples":{
"Add Non-Serialized Kit Quantity To Lot Response":{
"description":"Add Non-Serialized Kit Quantity To Lot Response",
"value":{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Add Non-Serialized Kit Quantity To Lot Not Found Response":{
"description":"Add Non-Serialized Kit Quantity To Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The non-serialized lot was not found."
}
}
}
}
}
}
},
"400":{
"description":"Invalid Non-serialized kit type or duplicate kit type in request or Invalid Lot ID.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Add Non-Serialized Kit Quantity To Lot Bad Request Response":{
"description":"Add Non-Serialized Kit Quantity To Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The quantity to add is invalid for the selected lot."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Add Non-Serialized Kit Quantity To Lot Server Error Response":{
"description":"Add Non-Serialized Kit Quantity To Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while adding quantity to the non-serialized lot."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-nsinventory-lots-{lotId}-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-nsinventory-lots-lotid-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/nsinventorystatuses/allowed/{fromInventoryStatusId}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Non-Serialized Kits APIs/Get allowed inventory status for non-serialized kits"
],
"summary":"v1.0",
"description":"Retrieves allowed inventory status for non-serialized kits. Rights: OrsInventoryGet.",
"operationId":"getAllowedInventoryStatuses_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"fromInventoryStatusId",
"in":"path",
"description":"ID of the initial inventory status in status transition.",
"required":true,
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Allowed Non-Serialized Inventory Statuses Response":{
"description":"Get Allowed Non-Serialized Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":10,
"inventoryStatus":"Dispensed"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Allowed Non-Serialized Inventory Statuses Server Error Response":{
"description":"Get Allowed Non-Serialized Inventory Statuses Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving allowed non-serialized inventory statuses."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-nsinventorystatuses-allowed-{fromInventoryStatusId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-nsinventorystatuses-allowed-frominventorystatusid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/nsinventory/lots/{lotId}/quantity":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Non-Serialized Kits APIs/Get kit type quantities by lot ID"
],
"summary":"v1.0",
"description":"Retrieves the kit type quantities by lot ID.",
"operationId":"getKitTypeQuantitiesByLotId",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"lotId",
"in":"path",
"description":"Lot ID",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryStatus"
},
"examples":{
"Get Kit Type Quantities By Lot Response":{
"description":"Get Kit Type Quantities By Lot Response",
"value":{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Type Quantities By Lot Not Found Response":{
"description":"Get Kit Type Quantities By Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The non-serialized lot was not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Type Quantities By Lot Server Error Response":{
"description":"Get Kit Type Quantities By Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving kit type quantities for the non-serialized lot."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-nsinventory-lots-{lotId}-quantity-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-nsinventory-lots-lotid-quantity-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/nsinventory/audit":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Non-Serialized Kits APIs/Get audit details for non-serialized kits"
],
"summary":"v1.0",
"description":"Retrieves audit information of each kit from non-serialized inventory.
Rights: OrsInventoryGet.",
"operationId":"getNSKitsAudit",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"required":true,
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"required":true,
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":25
},
{
"name":"transactionId",
"in":"query",
"description":"String value for transaction ID of shipment.",
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditRequestV1"
},
"examples":{
"Get Non-Serialized Kits Audit Request":{
"description":"Get Non-Serialized Kits Audit Request",
"value":{
"kits":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
]
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/NSKitsAuditResponseV1"
},
"examples":{
"Get Non-Serialized Kits Audit Response":{
"description":"Get Non-Serialized Kits Audit Response",
"value":{
"count":1,
"offset":0,
"limit":25,
"audits":[
{
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"reason":"Inventory adjustment",
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID OR Study not found OR Inventory Source ID not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Serialized Kits Audit Not Found Response":{
"description":"Get Non-Serialized Kits Audit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No non-serialized kit audit data was found."
}
}
}
}
}
}
},
"400":{
"description":"Invalid Kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Serialized Kits Audit Bad Request Response":{
"description":"Get Non-Serialized Kits Audit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The non-serialized audit request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Serialized Kits Audit Server Error Response":{
"description":"Get Non-Serialized Kits Audit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving non-serialized kit audit data."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-nsinventory-audit-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-nsinventory-audit-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/nsinventory/kit-types/{kitTypeId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Non-Serialized Kits APIs/Get non-serialized kits by kit type ID"
],
"summary":"v1.0",
"description":"Retrieves non-serialized kits by kit type ID. Filtered by location, label, lotID and Kit Status.",
"operationId":"getNonSerializedKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitTypeId",
"in":"path",
"description":"Kit Type ID of a non-serialized kit.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"location",
"in":"query",
"description":"Location of the non-serialized kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE"
},
{
"name":"lotId",
"in":"query",
"description":"Lot ID of the non-serialized kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"labelGroupId",
"in":"query",
"description":"Label group of the non-serialized kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-GRP-001"
},
{
"name":"kitStatus",
"in":"query",
"description":"Inventory status of the non-serialized kit.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"required":true,
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"required":true,
"schema":{
"type":"integer",
"format":"int32"
},
"example":25
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Serialized Kits Response":{
"description":"Get Non-Serialized Kits Response",
"value":{
"status":"success",
"result":{
"offset":0,
"limit":25,
"count":1,
"totalResults":1,
"hasMore":false,
"kits":[
{
"nsInventoryId":"B1B8327AFAA6412287106192AB5984EF",
"inventoryStatusId":10,
"locationId":"1873CDF69E9B48B89B2D9E7951057D09",
"manufacturingLotId":"9BD49A59E47E4383B98802712763FD43",
"labelGroupId":"9BD49A59E47E4383B98802712763FD43",
"inventoryStatus":"Dispensed",
"manufacturingLotNumber":"Mlot1001",
"labelGroup":"Labelgroup1001",
"quantity":15,
"restrictedQuantity":3,
"versionStart":"2026-02-21T08:43:01Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionEnd":"3099-12-31T12:00:00Z",
"operationType":"UPDATE",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"Inventory adjustment",
"comment":"Units updated after review"
}
]
},
"errorData":null
}
}
}
}
}
},
"404":{
"description":"Invalid Kit Type ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Serialized Kits Not Found Response":{
"description":"Get Non-Serialized Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No non-serialized kit inventory was found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Serialized Kits Server Error Response":{
"description":"Get Non-Serialized Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving non-serialized kits."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-nsinventory-kit-types-{kitTypeId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-nsinventory-kit-types-kittypeid-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/nsinventory":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Non-Serialized Kits APIs/Update multiple non-serialized kits"
],
"summary":"v1.0",
"description":"Updates inventory status, location or label of multiple non-serialized kits.",
"operationId":"updateMultipleNonSerializedKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Request to update inventory status ID, label or location of multiple non-serialized kits.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/NsKitFiltersUpdateRequestV1"
},
"examples":{
"Update Multiple Non-Serialized Kits Request":{
"description":"Update Multiple Non-Serialized Kits Request",
"value":{
"kitTypeId":"B1B8327AFAA6412287106192AB5984EF",
"location":"SITE",
"lotId":"LOT-001",
"labelGroupId":"LABEL-GRP-001",
"fromInventoryStatusId":1,
"toInventoryStatusId":2,
"quantity":5
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Multiple Non-Serialized Kits Response":{
"description":"Update Multiple Non-Serialized Kits Response",
"value":{
"status":"success",
"result":{
"inventoryUpdated":5
},
"errorData":null
}
}
}
}
}
},
"400":{
"description":"Invalid update request",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Update Multiple Non-Serialized Kits Bad Request Response":{
"description":"Update Multiple Non-Serialized Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The non-serialized kit update request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Update Multiple Non-Serialized Kits Server Error Response":{
"description":"Update Multiple Non-Serialized Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating non-serialized kits."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-nsinventory-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-nsinventory-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/nsinventory/{nsinventoryId}":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Non-Serialized Kits APIs/Update non-serialized kits"
],
"summary":"v1.0",
"description":"Updates inventory status, location or label of a non-serialized kit.",
"operationId":"updateNonSerializedKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"nsinventoryId",
"in":"path",
"description":"Inventory ID of non-serialized kits",
"required":true,
"schema":{
"type":"string"
},
"example":"NSINV-000123"
}
],
"requestBody":{
"description":"Request to update inventory status ID, label or location.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/UpdateNSKitAttributesRequestV1"
},
"examples":{
"Update Non-Serialized Kit Attributes Request":{
"description":"Update Non-Serialized Kit Attributes Request",
"value":{
"inventoryStatusId":2,
"location":"SITE",
"lotId":"LOT-001",
"labelGroupId":"LABEL-GRP-001"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Non-Serialized Kit Response":{
"description":"Update Non-Serialized Kit Response",
"value":{
"status":"success",
"result":{
"inventoryUpdated":1
},
"errorData":null
}
}
}
}
}
},
"404":{
"description":"Invalid inventory ID.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Non-Serialized Kit Not Found Response":{
"description":"Update Non-Serialized Kit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The non-serialized inventory record was not found."
}
}
}
}
}
}
},
"400":{
"description":"Invalid update request",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Update Non-Serialized Kit Bad Request Response":{
"description":"Update Non-Serialized Kit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The non-serialized kit update payload is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Update Non-Serialized Kit Server Error Response":{
"description":"Update Non-Serialized Kit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating the non-serialized kit."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-nsinventory-{nsinventoryId}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-nsinventory-nsinventoryid-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/kits/existingdata":{
"post":{
"tags":[
"Randomization and Supplies/NonSubjectForm APIs/Get existing data from non-subject forms for kit IDs"
],
"summary":"v1.0",
"description":"Retrieves existing data from clinical supplies forms for kit IDs.",
"operationId":"getKitDetailsNonSubjectForm",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/NonSubjectFormRequest"
},
"examples":{
"Get Non-Subject Form Kit Details Request":{
"description":"Get Non-Subject Form Kit Details Request",
"value":{
"kitIds":[
"B1B8327AFAA6412287106192AB5984EF",
"F6B1A4D9C2EE4D7BAF0B70D0B3A2D1C9"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryDetailsResponse"
},
"examples":{
"Get Non-Subject Form Kit Details Response":{
"description":"Get Non-Subject Form Kit Details Response",
"value":{
"kitDetails":[
{
"propertyName":"Kit Description",
"propertyValue":"Bottle of tablets",
"srcId":"B1B8327AFAA6412287106192AB5984EF",
"srcType":"Inventory",
"propertyValueTimestamp":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Subject Form Kit Details Not Found Response":{
"description":"Get Non-Subject Form Kit Details Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"KIT-404",
"errorMessage":"No kit details were found for the supplied kit IDs.",
"details":{
"field":"kitIds",
"reason":"None of the kit identifiers matched inventory records."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Non-Subject Form Kit Details Server Error Response":{
"description":"Get Non-Subject Form Kit Details Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"KIT-500",
"errorMessage":"Unexpected error while retrieving kit details.",
"details":{
"operation":"getKitDetailsNonSubjectForm",
"reason":"The kit details lookup could not be completed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-kits-existingdata-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-kits-existingdata-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/partial-dispensation-settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Partial Dispensation/Get all partial dispensation details"
],
"summary":"v1.0",
"description":"Retrieves all partial dispensation details. Rights required: SupplySettingRightsGet.",
"operationId":"getPartialDispenationSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Get Partial Dispensation Settings Response":{
"description":"Get Partial Dispensation Settings Response",
"value":"0FB5A42D9AE843C3A06D78C2D56E43F1"
}
}
}
}
},
"400":{
"description":"Invalid Partial Dispensation ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid request."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-partial-dispensation-settings-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-partial-dispensation-settings-get"
},
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Partial Dispensation/Create partial dispensation settings"
],
"summary":"v1.0",
"description":"Adds partial dispensation settings. Rights required: SupplySettingRightsPost.",
"operationId":"createPartialDispensationSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PartialDispensationSettingsRequestV1"
},
"examples":{
"Create Partial Dispensation Settings Request":{
"description":"Create Partial Dispensation Settings Request",
"value":{
"kitTypeSrcIds":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
],
"startingVisitSrcId":"A313327EF13845169A8ADADDA435431F",
"startingVisitInstanceNumber":1,
"endingVisitSrcId":"D313327EF13845169A8ADADDA435431F",
"endingVisitInstanceNumber":3,
"enabled":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PartialDispensationSettingsResponseV1"
},
"examples":{
"Create Partial Dispensation Settings Response":{
"description":"Create Partial Dispensation Settings Response",
"value":{
"settingsId":"0FB5A42D9AE843C3A06D78C2D56E43F1",
"enabled":true
}
}
}
}
}
},
"400":{
"description":"Invalid Partial Dispensation Setting Details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid partial dispensation settings request."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-partial-dispensation-settings-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-partial-dispensation-settings-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/partial-dispensation-settings/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Partial Dispensation/Get partial dispensation settings of a given partial dispensation by ID"
],
"summary":"v1.0",
"description":"Retrieves partial dispensation settings details of a given partial dispensation definition identified by ID. Rights required: SupplySettingRightsGet.",
"operationId":"getPartialDispenationById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"id",
"in":"path",
"description":"Partial Dispensation ID to get.",
"required":true,
"schema":{
"type":"string"
},
"example":"0FB5A42D9AE843C3A06D78C2D56E43F1"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Get Partial Dispensation Settings By Id Response":{
"description":"Get Partial Dispensation Settings By Id Response",
"value":"0FB5A42D9AE843C3A06D78C2D56E43F1"
}
}
}
}
},
"400":{
"description":"Invalid Partial Dispensation ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid request."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-partial-dispensation-settings-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-partial-dispensation-settings-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Partial Dispensation/Update partial dispensation settings of a given partial dispensation by ID"
],
"summary":"v1.0",
"description":"Updates partial dispensation settings of a given partial dispensation definition identified by ID. Rights required: SupplySettingRightsPost.",
"operationId":"updatePartialDispensationSettings",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"id",
"in":"path",
"description":"Partial Dispensation ID to get.",
"required":true,
"schema":{
"type":"string"
},
"example":"0FB5A42D9AE843C3A06D78C2D56E43F1"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PartialDispensationUpdateSettingsRequestV1"
},
"examples":{
"Update Partial Dispensation Settings Request":{
"description":"Update Partial Dispensation Settings Request",
"value":{
"kitTypeSrcId":"19598B39542A4473AFF46B4EA901F75C",
"startingVisitSrcId":"19598B39542A4473AFF46B4EA901F75C",
"startingVisitInstanceNumber":1,
"endingVisitSrcId":"29598B39542A4473AFF46B4EA901F75C",
"endingVisitInstanceNumber":10,
"enabled":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PartialDispensationSettingsResponseV1"
},
"examples":{
"Update Partial Dispensation Settings Response":{
"description":"Update Partial Dispensation Settings Response",
"value":{
"settingsId":"0FB5A42D9AE843C3A06D78C2D56E43F1",
"enabled":true
}
}
}
}
}
},
"400":{
"description":"Invalid Partial Dispensation Setting Details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid update request."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-partial-dispensation-settings-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-partial-dispensation-settings-id-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Settings APIs/Partial Dispensation/Delete partial dispensation settings of a given partial dispensation definition by ID"
],
"summary":"v1.0",
"description":"Deletes partial dispensation settings of a given partial dispensation definition identified by ID. Rights required: SupplySettingRightsPost.",
"operationId":"deletePartialDispenationByIdById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"id",
"in":"path",
"description":"Partial Dispensation ID to delete.",
"required":true,
"schema":{
"type":"string"
},
"example":"0FB5A42D9AE843C3A06D78C2D56E43F1"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Delete Partial Dispensation Settings Response":{
"description":"Delete Partial Dispensation Settings Response",
"value":"0FB5A42D9AE843C3A06D78C2D56E43F1"
}
}
}
}
},
"400":{
"description":"Invalid Partial Dispensation Setting Details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid request."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-partial-dispensation-settings-{id}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-partial-dispensation-settings-id-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments/cancel":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Cancel reconciliation shipment"
],
"summary":"v1.0",
"description":"Cancels a reconciliation shipment.
Rights: OrsInventoryPost and OrsBlinded or OrsUnblinded.",
"operationId":"cancelReconShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Cancel recon shipment parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/CancelReconShipmentRequest"
},
"examples":{
"Cancel recon shipment":{
"description":"Cancel recon shipment",
"value":{
"shipmentId":"E39FF55A445543A38D513325664F0B2D",
"shipmentIds":[
"E39FF55A445543A38D513325664F0B2D"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation"
},
"403":{
"description":"User doesn't have access to the site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Cancel Recon Shipment Forbidden Response":{
"description":"Cancel Recon Shipment Forbidden Response",
"value":{
"errorCode":"RECON-SHIPMENT-403",
"errorMessage":"User does not have access to cancel the reconciliation shipment.",
"details":{
"shipmentId":"E39FF55A445543A38D513325664F0B2D",
"right":"OrsInventoryPost"
}
}
}
}
}
}
},
"400":{
"description":"'Invalid kit status.', 'Invalid shipment.', 'One or more shipments are not in a valid status.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Cancel Recon Shipment Bad Request Response":{
"description":"Cancel Recon Shipment Bad Request Response",
"value":{
"errorCode":"RECON-SHIPMENT-400",
"errorMessage":"The reconciliation shipment cannot be cancelled.",
"details":{
"field":"shipmentId",
"issue":"Shipment is already received."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Cancel Recon Shipment Server Error Response":{
"description":"Cancel Recon Shipment Server Error Response",
"value":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while cancelling the reconciliation shipment.",
"details":{
"operation":"cancelReconShipment",
"shipmentId":"E39FF55A445543A38D513325664F0B2D"
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-cancel-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-cancel-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments/{shipmentId}/destroyed":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Received shipment for destruction"
],
"summary":"v1.0",
"description":"Received shipment for destruction. Rights: OrsInventoryPost and either OrsBlinded or OrsUnblinded.",
"operationId":"destroyShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"requestBody":{
"description":"Received Shipment for destruction params.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ReconShipmentDestroyedRequest"
},
"examples":{
"Destroy shipment":{
"description":"Destroy shipment",
"value":{
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Success":{
"description":"Success",
"value":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
},
"403":{
"description":"User doesn't have access to the depot.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Destroy Shipment Forbidden Response":{
"description":"Destroy Shipment Forbidden Response",
"value":{
"errorCode":"RECON-SHIPMENT-403",
"errorMessage":"User does not have access to destroy the reconciliation shipment.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"right":"DepotReconcilePost"
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit OR Invalid order status.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Destroy Shipment Bad Request Response":{
"description":"Destroy Shipment Bad Request Response",
"value":{
"errorCode":"RECON-SHIPMENT-400",
"errorMessage":"The reconciliation shipment cannot be destroyed.",
"details":{
"field":"shipmentId",
"issue":"Shipment must be received before it can be destroyed."
}
}
}
}
}
}
},
"404":{
"description":"Study not found OR Invalid shipment.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Destroy Shipment Not Found Response":{
"description":"Destroy Shipment Not Found Response",
"value":{
"errorCode":"RECON-SHIPMENT-404",
"errorMessage":"The reconciliation shipment was not found.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"reason":"No shipment matched the supplied identifier."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Destroy Shipment Server Error Response":{
"description":"Destroy Shipment Server Error Response",
"value":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while destroying the reconciliation shipment.",
"details":{
"operation":"destroyShipment",
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-{shipmentId}-destroyed-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-shipmentid-destroyed-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments/mark-lost":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Mark reconciliation shipments as lost"
],
"summary":"v1.0",
"description":"Marks reconciliation shipments as lost. Rights: OrsInventoryPost and either OrsBlinded or OrsUnblinded.",
"operationId":"markLost",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Shipment IDs to be marked as Lost.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LostShipmentRequest"
},
"examples":{
"Mark lost shipment":{
"description":"Mark lost shipment",
"value":{
"shipmentIds":[
"E39FF55A445543A38D513325664F0B2D"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"Success":{
"description":"Success",
"value":[
"8ECE2C9D389645B09740DC7926DEFB69"
]
}
}
}
}
},
"403":{
"description":"User doesn't have access to the site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Mark Lost Shipment Forbidden Response":{
"description":"Mark Lost Shipment Forbidden Response",
"value":{
"errorCode":"RECON-SHIPMENT-403",
"errorMessage":"User does not have access to mark the shipment as lost.",
"details":{
"shipmentId":"E39FF55A445543A38D513325664F0B2D",
"right":"OrsInventoryPost"
}
}
}
}
}
}
},
"400":{
"description":"'Invalid shipment type', 'Invalid site ID', 'One or more shipments are invalid', 'Invalid kit status', 'Invalid shipment', 'One or more shipments are invalid'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Mark Lost Shipment Bad Request Response":{
"description":"Mark Lost Shipment Bad Request Response",
"value":{
"errorCode":"RECON-SHIPMENT-400",
"errorMessage":"The shipment cannot be marked as lost.",
"details":{
"field":"shipmentIds",
"issue":"Shipment is already destroyed."
}
}
}
}
}
}
},
"404":{
"description":"'Site not found', 'Shipment not found'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Mark Lost Shipment Not Found Response":{
"description":"Mark Lost Shipment Not Found Response",
"value":{
"errorCode":"RECON-SHIPMENT-404",
"errorMessage":"The shipment was not found.",
"details":{
"shipmentId":"E39FF55A445543A38D513325664F0B2D",
"reason":"No reconciliation shipment matched the supplied identifier."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Mark Lost Shipment Server Error Response":{
"description":"Mark Lost Shipment Server Error Response",
"value":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while marking the shipment as lost.",
"details":{
"operation":"markLost",
"shipmentId":"E39FF55A445543A38D513325664F0B2D"
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-mark-lost-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-mark-lost-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments/{shipmentId}/received":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Update shipment as received for destruction"
],
"summary":"v1.0",
"description":"Updates shipment as received for destruction. Rights: OrsInventoryPost and either OrsBlinded or OrsUnblinded.",
"operationId":"shipmentReceived",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"requestBody":{
"description":"Shipment received for destruction params.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReconShipmentReceiveRequest"
},
"examples":{
"Shipment received":{
"description":"Shipment received",
"value":{
"receivedKits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"depotReturnedUnits":2
},
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B",
"depotReturnedUnits":0
}
],
"confirmReceiptPerKit":true,
"partialUpdate":false
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReconShipmentReceivedResponse"
},
"examples":{
"Success":{
"description":"Success",
"value":{
"id":"8ECE2C9D389645B09740DC7926DEFB69",
"receivedDate":"2026-02-24T00:00:00.000Z",
"missingCount":1,
"receivedCount":3
}
}
}
}
}
},
"403":{
"description":"User doesn't have access to the depot.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Shipment Received Forbidden Response":{
"description":"Shipment Received Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RECON-SHIPMENT-403",
"errorMessage":"User does not have access to receive this reconciliation shipment.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"right":"DepotReconcilePost"
}
},
"version":1
}
}
}
}
}
},
"400":{
"description":"Invalid kit OR Invalid order status.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Shipment Received Bad Request Response":{
"description":"Shipment Received Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RECON-SHIPMENT-400",
"errorMessage":"The shipment receipt request is invalid.",
"details":{
"field":"receivedKits",
"issue":"At least one received kit entry is required when confirming per kit."
}
},
"version":1
}
}
}
}
}
},
"404":{
"description":"Study not found OR Invalid shipment.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Shipment Received Not Found Response":{
"description":"Shipment Received Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RECON-SHIPMENT-404",
"errorMessage":"The reconciliation shipment was not found.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"reason":"The shipment does not exist or is not eligible for receipt."
}
},
"version":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Shipment Received Server Error Response":{
"description":"Shipment Received Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while marking the shipment as received.",
"details":{
"operation":"shipmentReceived",
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69"
}
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-{shipmentId}-received-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-shipmentid-received-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments/{shipmentId}/received-date":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Update recon shipment received date"
],
"summary":"v1.0",
"description":"Updates received date for a shipment. Rights: ShipmentReceivedDatePut.",
"operationId":"updateReceivedDate",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Shipment received date parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedDateRequest"
},
"examples":{
"Update Shipment received Date Request":{
"description":"Update Shipment received Date Request",
"value":{
"receivedDate":"2026-02-24"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Update Shipment Received Date Response":{
"description":"Update Shipment Received Date Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Shipment Received Date Server Error Response":{
"description":"Update Shipment Received Date Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while updating the shipment received date.",
"details":{
"operation":"updateReceivedDate",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
},
"version":1
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Shipment Received Date Not Found Response":{
"description":"Update Shipment Received Date Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RECON-SHIPMENT-404",
"errorMessage":"The reconciliation shipment was not found.",
"details":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"reason":"No shipment matched the supplied identifier."
}
},
"version":1
}
}
}
}
}
},
"400":{
"description":"'Invalid received date' or 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Shipment Received Date Bad Request Response":{
"description":"Update Shipment Received Date Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RECON-SHIPMENT-400",
"errorMessage":"The shipment received date request is invalid.",
"details":{
"field":"receivedDate",
"issue":"Received date cannot be earlier than the ship date."
}
},
"version":1
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-{shipmentId}-received-date-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-shipmentid-received-date-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments/{shipmentId}/ship-date":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Update a shipment's ship date"
],
"summary":"v1.0",
"description":"Updates a shipment's ship date. Rights: OrsInventoryPost and either OrsBlinded or OrsUnblinded.",
"operationId":"updateShipDate",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"requestBody":{
"description":"Shipment ship date parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentShipDateRequest"
},
"examples":{
"Update ship date":{
"description":"Update ship date",
"value":{
"shipDate":"2019-06-17"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Success":{
"description":"Success",
"value":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
},
"403":{
"description":"'User doesn't have access to the site'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Ship Date Forbidden Response":{
"description":"Update Ship Date Forbidden Response",
"value":{
"errorCode":"RECON-SHIPMENT-403",
"errorMessage":"User does not have access to update the ship date.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"right":"OrsInventoryPost"
}
}
}
}
}
}
},
"400":{
"description":"'Invalid ship date. It must be in YYYY-MM-DD format', 'Invalid shipment type', 'Invalid current shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Ship Date Bad Request Response":{
"description":"Update Ship Date Bad Request Response",
"value":{
"errorCode":"RECON-SHIPMENT-400",
"errorMessage":"The ship date request is invalid.",
"details":{
"field":"shipDate",
"issue":"Ship date cannot be earlier than the creation date."
}
}
}
}
}
}
},
"404":{
"description":"Shipment not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Ship Date Not Found Response":{
"description":"Update Ship Date Not Found Response",
"value":{
"errorCode":"RECON-SHIPMENT-404",
"errorMessage":"The reconciliation shipment was not found.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"reason":"No shipment matched the supplied identifier."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Ship Date Server Error Response":{
"description":"Update Ship Date Server Error Response",
"value":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while updating the shipment ship date.",
"details":{
"operation":"updateShipDate",
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-{shipmentId}-ship-date-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-shipmentid-ship-date-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/recon/shipments/{shipmentId}/tracking":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Tracking/Update a shipment's tracking details"
],
"summary":"v1.0",
"description":"Updates a shipment's tracking details. Rights: OrsInventoryPost and either OrsBlinded or OrsUnblinded.",
"operationId":"updateTrackingDetails",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"requestBody":{
"description":"Shipment Tracking Details parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentTrackingDetailsRequest"
},
"examples":{
"Update tracking details":{
"description":"Update tracking details",
"value":{
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Success":{
"description":"Success",
"value":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
},
"403":{
"description":"User doesn't have access to the site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Tracking Details Forbidden Response":{
"description":"Update Tracking Details Forbidden Response",
"value":{
"errorCode":"RECON-SHIPMENT-403",
"errorMessage":"User does not have access to update tracking details.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"right":"OrsInventoryPost"
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Tracking Details Bad Request Response":{
"description":"Update Tracking Details Bad Request Response",
"value":{
"errorCode":"RECON-SHIPMENT-400",
"errorMessage":"The tracking details request is invalid.",
"details":{
"field":"trackingNumber",
"issue":"Tracking number must not be blank."
}
}
}
}
}
}
},
"404":{
"description":"Shipment not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Tracking Details Not Found Response":{
"description":"Update Tracking Details Not Found Response",
"value":{
"errorCode":"RECON-SHIPMENT-404",
"errorMessage":"The reconciliation shipment was not found.",
"details":{
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69",
"reason":"Tracking details can only be updated for an existing shipment."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Update Tracking Details Server Error Response":{
"description":"Update Tracking Details Server Error Response",
"value":{
"errorCode":"RECON-SHIPMENT-500",
"errorMessage":"Unexpected error while updating shipment tracking details.",
"details":{
"operation":"updateTrackingDetails",
"shipmentId":"8ECE2C9D389645B09740DC7926DEFB69"
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-recon-shipments-{shipmentId}-tracking-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-recon-shipments-shipmentid-tracking-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/dispensations-audit":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get the Subject Dispensation Audit report"
],
"summary":"v1.0",
"description":"Retrieves the Subject Dispensation report; Rights: SubjectDataReportPost. Site role: Blinded site user.",
"operationId":"getSubjectDispensationReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search specifications parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"403":{
"description":"403 Forbidden.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Validation error - Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-dispensations-audit-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-dispensations-audit-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/supplysettingsaudit":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get the Supply Settings audit report"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves the Supply Settings report; Rights: SubjectDataReportPost. Site role: Blinded site user.",
"operationId":"getSupplySettingsReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search specifications parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"403":{
"description":"403 Forbidden.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Validation error - Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-supplysettingsaudit-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-supplysettingsaudit-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/kits/blindedchainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Blinded Chain of Custody report"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves the Kit Blinded Chain of Custody report. Rights: UnblindedChainofCustodyReportPost.",
"operationId":"getBlindedChainOfCustodyReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-kits-blindedchainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-kits-blindedchainofcustody-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/kits/blindedInventory":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Inventory (Blinded) report"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves the Kit Inventory (Blinded) report. Rights: BlindedInventoryReportPost.",
"operationId":"getBlindedInventoryReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"403":{
"description":"The study does not match any study in Clinical One.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-kits-blindedInventory-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-kits-blindedinventory-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/blindedrandreport":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Blinded Randomization List report"
],
"summary":"v1.0",
"description":"Retrieves the Blinded Randomization List report. Rights: UnblindedRandomizationReportPost.",
"operationId":"getBlindedRandReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Request":{
"description":"Report Search Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
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"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-blindedrandreport-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-blindedrandreport-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/kits/chainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Chain of Custody Unblinded report"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves the Kit Chain of Custody (Unblinded) report. Rights: UnblindedChainofCustodyReportPost.",
"operationId":"getChainOfCustodyReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
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{
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},
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{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"sessionToken",
"in":"query",
"description":"Session token.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-blinded-titration-summary-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-blinded-titration-summary-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/titration-summary":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Titration Summary (Unblinded) report"
],
"summary":"v1.0",
"description":"Retrieves the Titration Summary (Unblinded) report. Rights: UnBlindedTitrationSummaryReport.",
"operationId":"getTitrationSummaryReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"sessionToken",
"in":"query",
"description":"Session token.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-titration-summary-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-titration-summary-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/kits/unblindedInventory":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Inventory (Unblinded) report"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves the Kit Inventory (Unblinded) report. Rights: UnblindedInventoryReportPost.",
"operationId":"getUnblindedInventoryReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"403":{
"description":"The study does not match any study in Clinical One.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-kits-unblindedInventory-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-kits-unblindedinventory-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/reports/unblinded-visit-schedule":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Unblinded Visit Schedule report"
],
"summary":"v1.0",
"description":"Retrieves the Unblinded Visit Schedule report. Rights: UnblindedSubjectVisitReport.",
"operationId":"getUnblindedVisitScheduleReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"sessionToken",
"in":"query",
"description":"Session token.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"example":{
"offset":0,
"limit":100,
"fieldSpecsList":[
]
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Report Error Response":{
"description":"Report Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"REPORT_ERROR",
"errorMessage":"The report request failed.",
"details":{
"context":"report",
"reason":"Review the error code and message for the failed report request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-reports-unblinded-visit-schedule-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-reports-unblinded-visit-schedule-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/depot/resupplies/updateselected":{
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Create or update selected depot resupply associations"
],
"summary":"v1.0",
"description":"Creates or updates selected associations between a resupply and a depot.
Rights: SupplySettingRightsPost.
Required sponsor roles are clinical supply manager and depot manager.",
"operationId":"associateDepotResupply",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Resupply group request parameters.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DepotResupplyRequestV1"
}
},
"examples":{
"Associate Depot Resupplies Request":{
"description":"Associate Depot Resupplies Request",
"value":[
{
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"resupplyId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SiteResupply"
}
}
}
}
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Depot Resupply Not Found Response":{
"description":"Associate Depot Resupply Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"The depot or resupply group was not found."
}
}
}
}
}
}
},
"400":{
"description":"'Depot in the study does not match the Clinical One study configuration', 'Duplicate depot'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Depot Resupply Bad Request Response":{
"description":"Associate Depot Resupply Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-400",
"errorMessage":"The depot resupply association request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Depot Resupply Server Error Response":{
"description":"Associate Depot Resupply Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while associating depot resupplies."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-depot-resupplies-updateselected-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-depot-resupplies-updateselected-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/site/resupplies/updateselected":{
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Create or update selected site resupply associations"
],
"summary":"v1.0",
"description":"Creates or updates selected associations between a resupply and a site.
Rights: SupplySettingRightsPost.
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"associateSiteResupply",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Resupply group request parameters.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SiteResupplyRequestV1"
}
},
"examples":{
"Associate Site Resupplies Request":{
"description":"Associate Site Resupplies Request",
"value":[
{
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"resupplyId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SiteResupplyResponse"
}
}
}
}
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Site Resupply Not Found Response":{
"description":"Associate Site Resupply Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"The site or resupply group was not found."
}
}
}
}
}
}
},
"400":{
"description":"'Site in the study does not match the Clinical One study configuration', 'Duplicate site'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Site Resupply Bad Request Response":{
"description":"Associate Site Resupply Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-400",
"errorMessage":"The site resupply association request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Site Resupply Server Error Response":{
"description":"Associate Site Resupply Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while associating site resupplies."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-site-resupplies-updateselected-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-site-resupplies-updateselected-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/resupplies":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Get all resupply groups"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves all resupply groups created for a study.
Rights: SupplySettingRightsGet. Required sponsor roles are clinical supply manager and site manager.triggerWeeks and resupplyWeeks fields aren't needed for Min/Max strategies, so they're hidden when fetched.",
"operationId":"getResupplyGroups",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"resupplyTypeId",
"in":"query",
"description":"ID of resupply type.",
"required":true,
"schema":{
"type":"integer",
"format":"int32",
"enum":[
null
]
},
"example":2
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupResponse"
}
}
}
},
"404":{
"description":"Resupply not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Groups Not Found Response":{
"description":"Get Resupply Groups Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"No resupply groups were found for the study."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Groups Server Error Response":{
"description":"Get Resupply Groups Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while retrieving resupply groups."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupplies-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupplies-get"
},
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Create a resupply group"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Creates a resupply group for a study.
Rights: SupplySettingRightsPost
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"createResupplyGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Resupply group request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupRequestV1"
},
"examples":{
"Create Resupply Group Request":{
"description":"Create Resupply Group Request",
"value":{
"resupplyName":"Site Resupply Group A",
"resupplyTypeId":2,
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"minBuffer":5,
"maxBuffer":50,
"initialShippingUnits":50,
"manualConsignment":50,
"triggerWeeks":3,
"resupplyWeeks":3
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Resupply Group Response":{
"description":"Create Resupply Group Response",
"value":{
"status":"SUCCESS"
}
}
}
}
}
},
"400":{
"description":"'Invalid resupply type', 'Duplicate resupply'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid resupply group request."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error while creating resupply group."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupplies-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupplies-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/resupplies/{resupplyId}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Get a resupply group by ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a resupply group by ID.
Rights: SupplySettingRightsGet. Required sponsor roles are clinical supply manager and site manager.",
"operationId":"getResupplyGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"resupplyId",
"in":"path",
"description":"ID of resupply group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupResponse"
}
}
}
},
"404":{
"description":"Resupply not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Group Not Found Response":{
"description":"Get Resupply Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"The resupply group was not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Group Server Error Response":{
"description":"Get Resupply Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while retrieving the resupply group."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupplies-{resupplyId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupplies-resupplyid-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Update a resupply by ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Updates a resupply group by ID.
Rights: SupplySettingRightsPost
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"updateResupplyGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"resupplyId",
"in":"path",
"description":"ID of resupply group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Resupply group request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupRequestV1"
},
"examples":{
"Update Resupply Group Request":{
"description":"Update Resupply Group Request",
"value":{
"resupplyId":"C36A3197FDEE433FB5547EE83DE99E4B",
"resupplyName":"Site Resupply Group A (Updated)",
"resupplyTypeId":2,
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"minBuffer":10,
"maxBuffer":60,
"initialShippingUnits":60,
"manualConsignment":60,
"triggerWeeks":4,
"resupplyWeeks":4
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation"
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Resupply Group Not Found Response":{
"description":"Update Resupply Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"The resupply group was not found."
}
}
}
}
}
}
},
"400":{
"description":"'Validation error, 'Invalid resupply type', 'Resupply already exists', 'Resupply contains duplicate IDs for kit types', 'Invalid kit type'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Resupply Group Bad Request Response":{
"description":"Update Resupply Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-400",
"errorMessage":"The resupply group update request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Resupply Group Server Error Response":{
"description":"Update Resupply Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while updating the resupply group."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupplies-{resupplyId}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupplies-resupplyid-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Delete a resupply by ID"
],
"summary":"v1.0",
"description":"Removes a resupply group by its ID.
Rights: SupplySettingRightsPost
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"deleteResupplyGroup",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"resupplyId",
"in":"path",
"description":"ID of resupply group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation"
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Resupply Group Not Found Response":{
"description":"Delete Resupply Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"The resupply group was not found."
}
}
}
}
}
}
},
"400":{
"description":"'Invalid resupply type', 'Resupply is in use by one or more sites'",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Resupply Group Bad Request Response":{
"description":"Delete Resupply Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-400",
"errorMessage":"The resupply group delete request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Resupply Group Server Error Response":{
"description":"Delete Resupply Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while deleting the resupply group."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupplies-{resupplyId}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupplies-resupplyid-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/depot/resupplies":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Get all depot resupplies"
],
"summary":"v1.0",
"description":"Retrieves all depot resupplies.
Rights: SupplySettingRightsPost.
Required sponsor roles are clinical supply manager and depot manager.",
"operationId":"getAllDepotResupplies",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SiteResupply"
}
}
}
}
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Depot Resupplies Not Found Response":{
"description":"Get All Depot Resupplies Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"No depot resupplies were found for the study."
}
}
}
}
}
}
},
"400":{
"description":"'The depot in the study does not match the Clinical One study configuration, 'Duplicate depot'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Depot Resupplies Bad Request Response":{
"description":"Get All Depot Resupplies Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-400",
"errorMessage":"The depot resupplies request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Depot Resupplies Server Error Response":{
"description":"Get All Depot Resupplies Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while retrieving depot resupplies."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-depot-resupplies-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-depot-resupplies-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/site/resupplies":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Get all site resupplies"
],
"summary":"v1.0",
"description":"Retrieves all site resupplies.
Rights: SupplySettingRightsPost.
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"getAllSiteResupplies",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SiteResuppliesResponse"
}
}
}
}
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Site Resupplies Not Found Response":{
"description":"Get All Site Resupplies Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-404",
"errorMessage":"No site resupplies were found for the study."
}
}
}
}
}
}
},
"400":{
"description":"'The site in the study does not match the Clinical One study configuration, 'Duplicate site'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Site Resupplies Bad Request Response":{
"description":"Get All Site Resupplies Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-400",
"errorMessage":"The site resupplies request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get All Site Resupplies Server Error Response":{
"description":"Get All Site Resupplies Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-500",
"errorMessage":"Unexpected error while retrieving site resupplies."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-site-resupplies-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-site-resupplies-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/resupply/initial":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create a resupply strategy"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Creates a first shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"initial",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InitialResupplyRequest"
},
"examples":{
"Create Initial Resupply Request":{
"description":"Create Initial Resupply Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E",
"siteId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
},
"required":true
},
"responses":{
"410":{
"description":"Deprecated: This endpoint is no longer available.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Initial Resupply Gone Response":{
"description":"Create Initial Resupply Gone Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-410",
"errorMessage":"This initial resupply endpoint is no longer available. Use the latest version instead.",
"details":{
"endpoint":"/v1.0/studies/{studyId}/{mode}/resupply/initial",
"reason":"The v1.0 initial resupply API has been retired."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupply-initial-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupply-initial-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/resupply/manual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create manual shipment in resupply strategy"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Creates a manual shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"manual",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManualSupplyRequestV1"
},
"examples":{
"Create Manual Shipment Request":{
"description":"Create Manual Shipment Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E",
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"kits":[
{
"kitTypeId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"quantity":2
}
]
}
}
}
}
},
"required":true
},
"responses":{
"410":{
"description":"Deprecated: This endpoint is no longer available.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Manual Shipment Gone Response":{
"description":"Create Manual Shipment Gone Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-410",
"errorMessage":"This manual shipment endpoint is no longer available. Use the latest version instead.",
"details":{
"endpoint":"/v1.0/studies/{studyId}/{mode}/resupply/manual",
"reason":"The v1.0 manual resupply API has been retired."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupply-manual-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupply-manual-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/resupply/depotmanual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create manual depot shipment"
],
"summary":"v1.0",
"description":"Creates a manual depot shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"manualDepot",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Manual depot-to-depot supply request parameter.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManualDepotSupplyRequest"
},
"examples":{
"Create Depot Manual Shipment Request":{
"description":"Create Depot Manual Shipment Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E",
"kits":[
{
"kitTypeId":"B1B8327AFAA6412287106192AB5984EF",
"quantity":"2"
}
],
"shippedFrom":"B1B8327AFAA6412287106192AB5984EF",
"shippedTo":"ABC8327AFAA6412287106192AB5984EF"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Depot Manual Shipment Response":{
"description":"Create Depot Manual Shipment Response",
"value":{
"status":"SUCCESS"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"message":"Depot not found for shippedFrom location."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"message":"Unexpected error while creating depot manual shipment."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupply-depotmanual-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupply-depotmanual-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/resupply/resupply":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create a resupply strategy"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Creates a resupply strategy for a study. Rights: OrsSupplyManagerPost. If the Resupply type is Predictive for any site and Trigger weeks and Resupply weeks aren't defined for any resupplykit type, a configuration exception is thrown. If Min/Max buffers aren't defined, the resupply strategy would use 0for the buffers. No exception is thrown.",
"operationId":"resupply",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyRequestV1"
},
"examples":{
"Create Resupply Request":{
"description":"Create Resupply Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E"
}
}
}
}
},
"required":true
},
"responses":{
"410":{
"description":"Deprecated: This endpoint is no longer available.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Resupply Gone Response":{
"description":"Create Resupply Gone Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RESUPPLY-410",
"errorMessage":"This resupply endpoint is no longer available. Use the latest version instead.",
"details":{
"endpoint":"/v1.0/studies/{studyId}/{mode}/resupply/resupply",
"reason":"The v1.0 resupply API has been retired."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-resupply-resupply-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-resupply-resupply-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/resupply/initial":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create first shipment in resupply strategy"
],
"summary":"v2.0",
"description":"Creates a first shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"initial_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Initial resupply request parameter.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InitialResupplyRequest"
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ResupplyResponse"
}
},
"examples":{
"Create Initial Shipment Response":{
"description":"Create Initial Shipment Response",
"value":[
{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"message":"Study not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"message":"Unexpected error while creating initial shipment."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupply-initial-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupply-initial-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/resupply/manual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create manual shipment in resupply strategy"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Creates a manual shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"manual_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Manual supply request parameter.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManualSupplyRequestV1"
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ManualResupplyResponse"
}
},
"examples":{
"Create Manual Shipment Response":{
"description":"Create Manual Shipment Response",
"value":[
{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"message":"Study not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"message":"Unexpected error while creating manual shipment."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupply-manual-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupply-manual-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/resupply/depotmanual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create manual depot shipment"
],
"summary":"v2.0",
"description":"Creates a manual depot shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"manualDepot_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Manual depot-to-depot supply request parameter.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManualDepotSupplyRequest_v2"
},
"examples":{
"Create Depot Manual Shipment Request":{
"description":"Create Depot Manual Shipment Request",
"value":{
"kits":[
{
"kitTypeId":"B1B8327AFAA6412287106192AB5984EF",
"quantity":"2"
}
],
"shippedFrom":"B1B8327AFAA6412287106192AB5984EF",
"shippedTo":"ABC8327AFAA6412287106192AB5984EF",
"transactionId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Create Depot Manual Shipment Response":{
"description":"Create Depot Manual Shipment Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"message":"Depot not found for shippedFrom location."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"message":"Unexpected error while creating depot manual shipment."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupply-depotmanual-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupply-depotmanual-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/resupply/resupply":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create a resupply strategy"
],
"summary":"v2.0",
"description":"Creates a resupply strategy for a study. Rights: OrsSupplyManagerPost. If the Resupply type is Predictive for any site and Trigger weeks and Resupply weeks aren't defined for any resupplykit type, a configuration exception is thrown. If Min/Max buffers aren't defined, the resupply strategy would use 0for the buffers. No exception is thrown.",
"operationId":"resupply_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Resupply request parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyRequestV1"
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ResupplyResponse"
}
},
"examples":{
"Create Resupply Response":{
"description":"Create Resupply Response",
"value":[
{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"message":"Study not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"message":"Unexpected error while creating resupply."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupply-resupply-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupply-resupply-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/{studyVersion}/rnddesign/{rndDesignId}/treatments":{
"get":{
"tags":[
"Randomization and Supplies/Randomization APIs/Get list of all treatment arms for a randomization"
],
"summary":"v1.0",
"description":"Retrieves a list of all treatment arms for a randomization design. Rights: DesignerRandListGet.",
"operationId":"getTreatments",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyVersion",
"in":"path",
"description":"Version of the study.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"rndDesignId",
"in":"path",
"description":"ID of the randomization design.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Treatment"
}
},
"examples":{
"Get Treatments Response":{
"description":"Get Treatments Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"versionStart":"23-NOV-2018 08.43.01.700136000 AM",
"versionEnd":"23-NOV-2018 08.43.01.700136000 AM",
"description":"Treatment description",
"externalTreatmentId":"Treatment A",
"shortName":"TxA",
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"23-NOV-2018 08.43.01.700136000 AM",
"srcId":"B1B8327AFAA6412287106192AB5984EF",
"srcVersionStart":"23-NOV-2018 08.43.01.700136000 AM",
"operationType":"MODIFIED",
"objectVersionNumber":5,
"softwareVersionNumber":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Some reason",
"comment":"Some comment"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Treatments Server Error Response":{
"description":"Get Treatments Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving treatments.",
"details":{
"operation":"getTreatments",
"reason":"The treatment lookup failed."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found. Or randomization design not found",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Treatments Study Not Found Response":{
"description":"Get Treatments Study Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The study was not found.",
"details":{
"field":"studyId",
"reason":"The supplied study identifier does not exist."
}
}
}
},
"Get Treatments Design Not Found Response":{
"description":"Get Treatments Design Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The randomization design was not found.",
"details":{
"field":"rndDesignId",
"reason":"The supplied randomization design identifier does not exist for the study version."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-{studyVersion}-rnddesign-{rndDesignId}-treatments-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-studyversion-rnddesign-rnddesignid-treatments-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlistdesigns/randlists/{listId}/studyversions/{studyVersion}":{
"put":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Designs/Associate randomization design to randomization list"
],
"summary":"v1.0",
"description":"Associates a randomization design to a randomization list. Rights: OrsRandListPost, OrsUnblinded.",
"operationId":"associateRandDesignToRandList",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"listId",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyVersion",
"in":"path",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/RndDesignListRequest"
},
"examples":{
"Associate Design To List Request":{
"description":"Associate Design To List Request",
"value":{
"randDesignSrcIds":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Associate Design To List Response":{
"description":"Associate Design To List Response",
"value":"SUCCESS"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Design To List Server Error Response":{
"description":"Associate Design To List Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while associating randomization designs to the list.",
"details":{
"operation":"associateRandDesignToRandList",
"reason":"The randomization design association failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or randomization list not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Design To List Not Found Response":{
"description":"Associate Design To List Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The randomization list was not found.",
"details":{
"field":"listId",
"reason":"The supplied randomization list identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"For randomization design not found or randomization list can't be generated as there is no algorithm for the randomization designOr you must associate the randomization design with a visit before you can create a randomization listOr the combination of study version and randomization design is already associated with another randomization listOr treatment arms in the study version aren't the same as the treatment arms in the randomization listOr the type of randomization used to create the list doesn't match the type in the randomization designOr the stratum groups in the study version aren't the same as the stratum groups in the randomization listOr you can't use this randomization list. Cohort groups in the study version aren't the same as the cohort groups in the randomization list",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Associate Design To List Bad Request Response":{
"description":"Associate Design To List Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization design association request is invalid.",
"details":{
"field":"randDesignSrcIds",
"reason":"At least one valid randomization design identifier must be provided."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlistdesigns-randlists-{listId}-studyversions-{studyVersion}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlistdesigns-randlists-listid-studyversions-studyversion-put"
},
"delete":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Designs/Dissociate randomization design from randomization list"
],
"summary":"v1.0",
"description":"Dissociates a randomization design from a randomization list in the system. Rights: OrsRandListPost, OrsUnblinded.",
"operationId":"disassociateRandDesignsFromRandList",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"listId",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyVersion",
"in":"path",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"examples":{
"Disassociate Design From List Success Response":{
"description":"Request succeeds with no response body."
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Disassociate Design From List Server Error Response":{
"description":"Disassociate Design From List Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while removing randomization designs from the list.",
"details":{
"operation":"disassociateRandDesignsFromRandList",
"reason":"The randomization design disassociation failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or randomization list not found or design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Disassociate Design From List Not Found Response":{
"description":"Disassociate Design From List Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The randomization list was not found.",
"details":{
"field":"listId",
"reason":"The supplied randomization list identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"Randomization design is not associated with randomization list for this study version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Disassociate Design From List Bad Request Response":{
"description":"Disassociate Design From List Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization design disassociation request is invalid.",
"details":{
"field":"studyVersion",
"reason":"The supplied study version is invalid or missing."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlistdesigns-randlists-{listId}-studyversions-{studyVersion}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlistdesigns-randlists-listid-studyversions-studyversion-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/{studyVersion}/randlist/generate":{
"post":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Create randomization list"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Generates a randomization list in the study; Rights: DesignerRandListPost.",
"operationId":"create_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyVersion",
"in":"path",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateRndListRequest"
},
"examples":{
"Create Randomization List Request":{
"description":"Create Randomization List Request",
"value":{
"title":"UPL_RL191_V1001",
"description":"Randomization list with demographic cohort",
"treatmentRatioMultiplier":5,
"initialRandNumber":1,
"srcId":"B1B8327AFAA6412287106192AB5984EF",
"srcVersionStart":"23-NOV-2018 08.43.01.700136000 AM",
"noOfRows":5,
"blocks":5,
"blocksPerStratum":5,
"blocksPerCohort":5,
"blocksPerStratumPerCohort":5,
"mode":"test"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateResponse"
},
"examples":{
"Create Randomization List Response":{
"description":"Create Randomization List Response",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E",
"status":"QUEUED"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while generating randomization list."
}
}
}
}
}
}
},
"404":{
"description":"For Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"Randomization design not found."
}
}
}
}
}
}
},
"400":{
"description":"For algorithm not defined for the randomization design or randomization design not associated with a visit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"Invalid generate randomization list request."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-{studyVersion}-randlist-generate-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-studyversion-randlist-generate-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlists/file/{fileId}":{
"delete":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Delete randomization list file"
],
"summary":"v1.0",
"description":"Removes randomization list file from the system. Rights: DesignerRandListUpload, OrsUnblinded.",
"operationId":"deleteRndListFile_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"fileId",
"in":"path",
"description":"ID of the file.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Delete Randomization List File Response":{
"description":"Delete Randomization List File Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Randomization List File Server Error Response":{
"description":"Delete Randomization List File Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while deleting the randomization list file.",
"details":{
"operation":"deleteRndListFile",
"reason":"The randomization list file delete request failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or file not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Randomization List File Not Found Response":{
"description":"Delete Randomization List File Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The randomization list file was not found.",
"details":{
"field":"fileId",
"reason":"The supplied randomization list file identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"For when a randomization list is associated with randomizations",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Delete Randomization List File Bad Request Response":{
"description":"Delete Randomization List File Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization list file delete request is invalid.",
"details":{
"field":"fileId",
"reason":"The supplied file identifier is not a valid UUID."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlists-file-{fileId}-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlists-file-fileid-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlists/{rndlistid}/export":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Export/Export randomization list"
],
"summary":"v1.0",
"description":"Exports a randomization list. Rights: DesignerRandListGet.",
"operationId":"export_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"RNDLIST-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Export Randomization List Response":{
"description":"Export Randomization List Response",
"value":{
"status":"SUCCESS",
"message":"The randomization list export was created successfully."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Export Randomization List Server Error Response":{
"description":"Export Randomization List Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while exporting the randomization list.",
"details":{
"operation":"exportRndList",
"reason":"The randomization list export failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or randomization list not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Export Randomization List Not Found Response":{
"description":"Export Randomization List Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The randomization list was not found.",
"details":{
"field":"rndlistid",
"reason":"The supplied randomization list identifier does not exist."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlists-{rndlistid}-export-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlists-rndlistid-export-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/rndListsByRegion/regions/{regionId}":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Designs/Check randomization design is blocked by region"
],
"summary":"v1.0",
"description":"Checks whether a randomization design is blocked by region or not. Rights: RegionGet.",
"operationId":"operationId",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"regionId",
"in":"path",
"description":"ID of the region",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RegionRandListTO"
}
},
"examples":{
"Get Randomization Lists By Region Response":{
"description":"Get Randomization Lists By Region Response",
"value":[
{
"regionId":"B1B8327AFAA6412287106192AB5984EF",
"randListId":"E39FF55A445543A38D513325664F0B2D"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization Lists By Region Server Error Response":{
"description":"Get Randomization Lists By Region Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving randomization lists by region.",
"details":{
"operation":"getRandListByRegion",
"reason":"The region-based randomization list lookup failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or randomization list not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization Lists By Region Not Found Response":{
"description":"Get Randomization Lists By Region Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The region was not found.",
"details":{
"field":"regionId",
"reason":"The supplied region identifier does not exist."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-rndListsByRegion-regions-{regionId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-rndlistsbyregion-regions-regionid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randnumberstatuses":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Numbers/Get random number statuses"
],
"summary":"v1.0",
"description":"Retrieves random number statuses. Rights: OrsRandListGet.",
"operationId":"getRandNumberStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandNumStatusesResponse"
}
},
"examples":{
"Get Random Number Statuses Response":{
"description":"Get Random Number Statuses Response",
"value":[
{
"statusId":1,
"statusName":"AVAILABLE"
},
{
"statusId":2,
"statusName":"USED"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Random Number Statuses Server Error Response":{
"description":"Get Random Number Statuses Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving randomization number statuses.",
"details":{
"operation":"getRandNumberStatuses",
"reason":"The randomization number statuses lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randnumberstatuses-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randnumberstatuses-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlists":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a randomization list. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlist",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization Lists Response":{
"description":"Get Randomization Lists Response",
"value":{
"randLists":[
{
"randListId":"E39FF55A445543A38D513325664F0B2D",
"randListName":"UPL_RL191_V1001"
}
]
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"No randomization lists found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving randomization lists."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlists-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlists-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlists/{rndlistid}/blocks":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Blocks/Get list of randomization blocks"
],
"summary":"v1.0",
"description":"Retrieves a list of randomization blocks. Rights: OrsRandListGet, OrsUnblinded.",
"operationId":"getRandlistBlocks",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"RNDLIST-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListBlockTO"
},
"examples":{
"Get Randomization List Blocks Response":{
"description":"Get Randomization List Blocks Response",
"value":{
"blocks":[
{
"blockNumber":1,
"size":4
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List Blocks Server Error Response":{
"description":"Get Randomization List Blocks Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving randomization list blocks.",
"details":{
"operation":"getRandlistBlocks",
"reason":"The randomization list blocks lookup failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For Invalid study ID or version or randomization list not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List Blocks Not Found Response":{
"description":"Get Randomization List Blocks Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"Randomization list blocks were not found.",
"details":{
"field":"rndlistid",
"reason":"The supplied randomization list does not contain any blocks."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlists-{rndlistid}-blocks-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlists-rndlistid-blocks-get"
},
"put":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Blocks/Update randomization list blocks"
],
"summary":"v1.0",
"description":"Updates randomization list blocks in a study. Rights: OrsRandListPost, OrsUnblinded.",
"operationId":"updateRandlistBlocks",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/RndListBlocks"
},
"examples":{
"Update Randomization List Blocks Request":{
"description":"Update Randomization List Blocks Request",
"value":{
"blocks":[
{
"block":5,
"blockedBy":"Site1001"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Update Randomization List Blocks Response":{
"description":"Update Randomization List Blocks Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Randomization List Blocks Server Error Response":{
"description":"Update Randomization List Blocks Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while updating randomization list blocks.",
"details":{
"operation":"updateRandlistBlocks",
"reason":"The block update failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For Invalid study ID or version or randomization List not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Randomization List Blocks Not Found Response":{
"description":"Update Randomization List Blocks Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The randomization list was not found.",
"details":{
"field":"rndlistid",
"reason":"The supplied randomization list identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"For a dynamic algorithm, you can't assign blocks to a blocked parameter. Or invalid blocked by value.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Randomization List Blocks Bad Request Response":{
"description":"Update Randomization List Blocks Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization list blocks update request is invalid.",
"details":{
"field":"blocks",
"reason":"At least one valid randomization block must be provided."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlists-{rndlistid}-blocks-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlists-rndlistid-blocks-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlists/{rndlistid}":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list by ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a randomization list by ID. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlistById",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"RNDLIST-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO"
},
"examples":{
"Get Randomization List By Id Response":{
"description":"Get Randomization List By Id Response",
"value":{
"randListId":"E39FF55A445543A38D513325664F0B2D",
"randListName":"UPL_RL191_V1001"
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"Randomization list not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving the randomization list."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlists-{rndlistid}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlists-rndlistid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlistdesigns":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Designs/Get randomization design list"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a randomization design list. Rights: OrsRandListGet, OrsUnblinded.",
"operationId":"getRandomizationListDesigns",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RndListDesignList"
}
},
"examples":{
"Get Randomization List Designs Response":{
"description":"Get Randomization List Designs Response",
"value":[
{
"randListId":"E39FF55A445543A38D513325664F0B2D",
"randListName":"UPL_RL191_V1001",
"randDesigns":[
{
"randDesignId":"8ECE2C9D389645B09740DC7926DEFB69",
"randDesignName":"Design A"
}
]
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List Designs Server Error Response":{
"description":"Get Randomization List Designs Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving randomization list designs.",
"details":{
"operation":"getRandomizationListDesigns",
"reason":"The randomization list designs lookup failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List Designs Not Found Response":{
"description":"Get Randomization List Designs Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"No randomization list designs were found.",
"details":{
"field":"studyId",
"reason":"The supplied study does not contain randomization list designs."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlistdesigns-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlistdesigns-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/randlists/{rndlistid}/randnumber/randstatus":{
"put":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Numbers/Update randomization status"
],
"summary":"v1.0",
"description":"Updates randomization status. Rights: OrsRandListPost, OrsUnblinded.",
"operationId":"updateRandStatus",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/RandNumberStatusTO"
},
"examples":{
"Update Randomization Status Request":{
"description":"Update Randomization Status Request",
"value":{
"randNumberId":"B1B8327AFAA6412287106192AB5984EF",
"randStatusId":5,
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"reason":"Randomization status update request"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Update Randomization Status Response":{
"description":"Update Randomization Status Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Randomization Status Server Error Response":{
"description":"Update Randomization Status Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while updating the randomization status.",
"details":{
"operation":"updateRandStatus",
"reason":"The randomization status update failed."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or randomization list not found. Or randomization number not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Randomization Status Not Found Response":{
"description":"Update Randomization Status Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The randomization list was not found.",
"details":{
"field":"rndlistid",
"reason":"The supplied randomization list identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid rand status or for manually assigning a randomization number to a subject. Or randomization number and subject are associated with different sites.Or Randomization number and subject are associated with different countries. Or no stratum group is associated with the random number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Randomization Status Bad Request Response":{
"description":"Update Randomization Status Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization status update request is invalid.",
"details":{
"field":"randNumberStatus",
"reason":"The randomization status must be one of the supported status values."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-randlists-{rndlistid}-randnumber-randstatus-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-randlists-rndlistid-randnumber-randstatus-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/{studyVersion}/rnddesign/{rndDesignId}/rndlist/upload/{fileId}/fileheaders":{
"get":{
"tags":[
"Randomization and Supplies/Randomization APIs/Get list of headers from a CSV file"
],
"summary":"v1.0",
"description":"Retrieves a list of headers for a randomization list in a CSV file. Rights: DesignerRandListUpload.",
"operationId":"getCSVHeaders",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"containsHeadersRow",
"in":"query",
"description":"Specify whether the headers row is included. Default value is 'y'.",
"schema":{
"type":"string",
"default":"y"
},
"example":"y"
},
{
"name":"studyVersion",
"in":"path",
"description":"Version of the study.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"fileId",
"in":"path",
"description":"ID of the file.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndDesignId",
"in":"path",
"description":"ID of the randomization design.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UploadCSVHeaderResponse"
},
"examples":{
"Get CSV Headers Response":{
"description":"Get CSV Headers Response",
"value":{
"headers":[
"SUBJECT_ID",
"STRATUM",
"ARM"
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get CSV Headers Server Error Response":{
"description":"Get CSV Headers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while reading CSV headers.",
"details":{
"operation":"getHeadersFromFile",
"reason":"The CSV header extraction failed."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found. Or randomization design not found. Or design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get CSV Headers Study Or Design Not Found Response":{
"description":"Get CSV Headers Study Or Design Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The study or randomization design was not found.",
"details":{
"field":"rndDesignId",
"reason":"The supplied randomization design identifier does not exist for the study version."
}
}
}
},
"Get CSV Headers File Not Found Response":{
"description":"Get CSV Headers File Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The source file was not found.",
"details":{
"field":"fileId",
"reason":"No uploaded file matched the supplied file identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"Randomization list can't be generated/uploaded as there is no algorithm for the randomization designOr you must associate the randomization design with a visit before you can create/upload a randomization list for itOr the file can't be uploaded because it contains invalid content, such as special characters, empty cells, or empty rowsOr empty CSV content",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get CSV Headers Bad Request Response":{
"description":"Get CSV Headers Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The CSV header request is invalid.",
"details":{
"field":"containsHeadersRow",
"reason":"Use y or n and ensure the file does not contain empty rows, empty cells, or unsupported characters."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-{studyVersion}-rnddesign-{rndDesignId}-rndlist-upload-{fileId}-fileheaders-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-studyversion-rnddesign-rnddesignid-rndlist-upload-fileid-fileheaders-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/{studyVersion}/rnddesign/{rndDesignId}/rndlist/upload/csvuniquevalues":{
"post":{
"tags":[
"Randomization and Supplies/Randomization APIs/Get unique values for treatments, strata, or cohorts from a CSV file"
],
"summary":"v1.0",
"description":"Retrieves unique values for treatment arms, strata, and/or cohorts for a randomization list in a CSV file. Rights: DesignerRandListUpload.",
"operationId":"getUniqueValues",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndDesignId",
"in":"path",
"description":"ID of the randomization design.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"path",
"description":"Version of the study.",
"required":true,
"schema":{
"type":"string"
},
"example":1
}
],
"requestBody":{
"description":"Randomization list upload parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RndListUploadRequest"
},
"examples":{
"Get Unique Values Request":{
"description":"Get Unique Values Request",
"value":{
"fileId":"C36A3197FDEE433FB5547EE83DE99E4B",
"containsHeadersRow":"y",
"headerMappings":[
{
"fileHeader":"Treatment",
"dbHeader":"TREATMENT"
},
{
"fileHeader":"Stratum",
"dbHeader":"STRATUM"
},
{
"fileHeader":"Cohort",
"dbHeader":"COHORT"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RndListMappingResponse"
},
"examples":{
"Get Unique Values Response":{
"description":"Get Unique Values Response",
"value":{
"treatments":[
"TRT-A",
"TRT-B"
],
"stratums":[
"Male",
"Female"
],
"cohorts":[
"Cohort-1"
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Unique Values Server Error Response":{
"description":"Get Unique Values Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving unique values.",
"details":{
"operation":"getUniqueDataValues",
"reason":"The file values could not be analyzed."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found. Or randomization design not found. Or design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Unique Values Not Found Response":{
"description":"Get Unique Values Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The study or randomization design was not found.",
"details":{
"field":"rndDesignId",
"reason":"The supplied randomization design identifier does not exist for the study version."
}
}
}
}
}
}
}
},
"400":{
"description":"Randomization list can't be generated/uploaded as there is no algorithm for the randomization designOr you must associate the randomization design with a visit before you can create/upload a randomization list for itOr the file can't be uploaded because it contains invalid content, such as special characters, empty cells, or empty rowsOr empty CSV content",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Unique Values Bad Request Response":{
"description":"Get Unique Values Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The unique values request is invalid.",
"details":{
"field":"headerMappings",
"reason":"Header mappings must match the uploaded file and the file must not contain empty rows, empty cells, or unsupported characters."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-{studyVersion}-rnddesign-{rndDesignId}-rndlist-upload-csvuniquevalues-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-studyversion-rnddesign-rnddesignid-rndlist-upload-csvuniquevalues-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/{studyVersion}/rnddesign/{rndDesignId}/rndlist/upload/uploadrndlist":{
"post":{
"tags":[
"Randomization and Supplies/Randomization APIs/Upload randomization list based on header mappings and treatment, cohort, stratum mappings"
],
"summary":"v1.0",
"description":"Uploads a randomization list in Oracle Clinical One Platform based on the mapped headers and treatment, cohort, stratum mappings. Rights: DesignerRandListUpload.",
"operationId":"upload",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"rndDesignId",
"in":"path",
"description":"ID of the randomization design.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"path",
"description":"Version of the study.",
"required":true,
"schema":{
"type":"string"
},
"example":1
}
],
"requestBody":{
"description":"Randomization list upload parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RndListUploadRequest"
},
"examples":{
"Upload Randomization List Request":{
"description":"Upload Randomization List Request",
"value":{
"fileId":"C36A3197FDEE433FB5547EE83DE99E4B",
"containsHeadersRow":"y",
"headerMappings":[
{
"fileHeader":"Treatment",
"dbHeader":"TREATMENT"
},
{
"fileHeader":"Stratum",
"dbHeader":"STRATUM"
},
{
"fileHeader":"Cohort",
"dbHeader":"COHORT"
}
],
"treatmentMappings":[
{
"dataFromFile":"TRT-A",
"dataId":"B1B8327AFAA6412287106192AB5984EF"
},
{
"dataFromFile":"TRT-B",
"dataId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"stratumMappings":[
{
"dataFromFile":"Male",
"dataId":"89EE76326E984B548D594D592E5C7FC2"
}
],
"cohortMappings":[
{
"dataFromFile":"Cohort-1",
"dataId":"D313327EF13845169A8ADADDA435431E"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateResponse"
},
"examples":{
"Upload Randomization List Response":{
"description":"Upload Randomization List Response",
"value":{
"listId":"4FEBE3E166454E2687C6FAC306E7C86E",
"noOfRowsGenerated":150
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Randomization List Server Error Response":{
"description":"Upload Randomization List Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while uploading the randomization list.",
"details":{
"operation":"upload",
"reason":"The randomization list upload failed."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found. Or randomization design not found. Or design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Randomization List Study Or Design Not Found Response":{
"description":"Upload Randomization List Study Or Design Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The study or randomization design was not found.",
"details":{
"field":"rndDesignId",
"reason":"The supplied randomization design identifier does not exist for the study version."
}
}
}
},
"Upload Randomization List File Not Found Response":{
"description":"Upload Randomization List File Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The source file was not found.",
"details":{
"field":"fileId",
"reason":"No uploaded file matched the supplied file identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"Randomization list can't be generated/uploaded as there is no algorithm for the randomization designOr you must associate the randomization design with a visit before you can create/upload a randomization list for itOr the file can't be uploaded because it contains invalid content, such as special characters, empty cells, or empty rowsOr empty CSV content",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload Randomization List Algorithm Missing Response":{
"description":"Upload Randomization List Algorithm Missing Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization list upload request is invalid.",
"details":{
"field":"rndDesignId",
"reason":"The randomization design does not have an algorithm configured."
}
}
}
},
"Upload Randomization List Invalid CSV Response":{
"description":"Upload Randomization List Invalid CSV Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization list upload request is invalid.",
"details":{
"field":"fileId",
"reason":"The file contains invalid content such as empty rows, empty cells, or unsupported characters."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-{studyVersion}-rnddesign-{rndDesignId}-rndlist-upload-uploadrndlist-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-studyversion-rnddesign-rnddesignid-rndlist-upload-uploadrndlist-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/{studyVersion}/rnddesign/{rndDesignId}/rndlist/upload/uploadfile":{
"post":{
"tags":[
"Randomization and Supplies/Randomization APIs/Upload randomization list file from a file service into RTSM"
],
"summary":"v1.0",
"description":"Uploads randomization list as a CSV file from File Service into ORS. Rights: DesignerRandListUpload.",
"operationId":"uploadFile_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyVersion",
"in":"path",
"description":"Version of the study.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"rndDesignId",
"in":"path",
"description":"ID of the randomization design.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Randomization list upload parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FileUploadRequest"
},
"examples":{
"Upload File Request":{
"description":"Upload File Request",
"value":{
"name":"Randomization List 1001",
"description":"Randomization list upload for study version 1.0",
"fileName":"rndlist-1001.csv"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FileUploadResponse"
},
"examples":{
"Upload File Response":{
"description":"Upload File Response",
"value":{
"fileId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload File Server Error Response":{
"description":"Upload File Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while uploading the randomization list file.",
"details":{
"operation":"uploadFile",
"reason":"The randomization list file could not be uploaded."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found. Or randomization design not found. Or design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload File Study Or Design Not Found Response":{
"description":"Upload File Study Or Design Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The study or randomization design was not found.",
"details":{
"field":"rndDesignId",
"reason":"The supplied randomization design identifier does not exist for the study version."
}
}
}
},
"Upload File Source File Not Found Response":{
"description":"Upload File Source File Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-404",
"errorMessage":"The source file was not found.",
"details":{
"field":"fileName",
"reason":"No uploaded file matched the supplied file name."
}
}
}
}
}
}
}
},
"400":{
"description":"Randomization list can't be generated/uploaded as there is no algorithm for the randomization design.Or you must associate the randomization design with a visit before you can create/upload a randomization list for itOr randomization list already exists",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Upload File Bad Request Response":{
"description":"Upload File Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-400",
"errorMessage":"The randomization list file upload request is invalid.",
"details":{
"field":"rndDesignId",
"reason":"The randomization design does not have an algorithm configured."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-{studyVersion}-rnddesign-{rndDesignId}-rndlist-upload-uploadfile-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-studyversion-rnddesign-rnddesignid-rndlist-upload-uploadfile-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a kit's details by order. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-000123"
},
{
"name":"orderBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered.",
"required":true,
"schema":{
"type":"string"
},
"example":"kitNumber"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentKitsResponseV1"
},
"examples":{
"Get Shipment Kits Response":{
"description":"Get Shipment Kits Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":5,
"sequenceNumber":5,
"barcode":"KIT-000005"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-kits-get"
},
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Add kits to a shipment"
],
"summary":"v1.0",
"description":"Adds kits to an order shipment. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"addKitsToShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Kits to be added to the shipment.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentAddKitsRequest"
},
"examples":{
"Add Kits To Shipment Request":{
"description":"Add Kits To Shipment Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Add Kits Response":{
"description":"Add Kits Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-kits-post"
},
"delete":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Delete kits from a shipment"
],
"summary":"v1.0",
"description":"Removes kits from an order shipment. Rights: OrsInventoryDelete, OrsUnblinded.",
"operationId":"removeKitsFromShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Kits to be removed from the shipment.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentRemoveKitsRequest"
},
"examples":{
"Remove Kits From Shipment Request":{
"description":"Remove Kits From Shipment Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Remove Kits Response":{
"description":"Remove Kits Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"'Invalid Kit', 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-delete",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-kits-delete"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/orders/{shipmentNumber}/assignkits":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Assign Pooling Shipment kits"
],
"summary":"v1.0",
"description":"Assign Pooling Shipment kits in a study's inventory. Rights: OrsInventoryPost and DepotShipmentReceiptPost/OrsBlinded.",
"operationId":"assignPoolingShipmentKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentNumber",
"in":"path",
"description":"Pooling shipment number.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-POOL-001"
}
],
"requestBody":{
"description":"Kits to be assigned.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PoolingShipmentRequestV1"
},
"examples":{
"Assign Pooling Shipment Kits Request":{
"description":"Assign Pooling Shipment Kits Request",
"value":{
"shipDate":"12-May-2023",
"trackingNumber":"123456",
"deliveryNumber":"88888",
"kits":[
{
"sequenceNumber":5,
"kitNumber":"KIT-000123",
"barcode":"61234",
"blockNumber":"5",
"poolingId":"PooledKitA",
"manufacturingLotNumber":"Lot A",
"itemNumber":"i"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PoolingShipmentResponseV1"
},
"examples":{
"Assign Pooling Shipment Kits Response":{
"description":"Assign Pooling Shipment Kits Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
},
"400":{
"description":"'Invalid shipment",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-{shipmentNumber}-assignkits-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-shipmentnumber-assignkits-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/orders-nsinventory":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/NS Inventory/Get non-serialized inventory order items"
],
"summary":"v1.0",
"description":"Retrieves all order items for non-serialized inventory.
Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getAllNSOrderItems",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"offset",
"in":"query",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
}
},
{
"name":"audit",
"in":"query",
"required":true,
"schema":{
"type":"boolean"
}
},
{
"name":"nsInventoryId",
"in":"query",
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"orderId",
"in":"query",
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/NSOrderInventoryResponse"
}
},
"examples":{
"Get NS Order Items Response":{
"description":"Get NS Order Items Response",
"value":[
{
"hasMore":false,
"totalResults":1,
"count":1,
"limit":100,
"offset":0,
"resultData":[
{
"orderItemId":"5BB2C53538C841268AB4E4A1E640D0C9",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"nsInventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"nsInventoryVersionStart":"2026-02-21T06:30:00Z",
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"transactionId":"D313327EF13845169A8ADADDA435431E",
"orderVersionStart":"2026-02-21T06:30:00Z",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"DATA ENTRY ERROR",
"comment":"Created non-serialized order item.",
"quantity":5,
"shipmentNumber":"SHIP-000123",
"lotNumber":"lot1",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB"
}
]
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
},
"400":{
"description":"Bad request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request parameters."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-nsinventory-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-nsinventory-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/orders-inventory/audit":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order items"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves all order items.
Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getAllOrderItems",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"offset",
"in":"query",
"required":true,
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"required":true,
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderItemResponse"
}
},
"examples":{
"Get Order Items Response":{
"description":"Get Order Items Response",
"value":[
{
"hasMore":false,
"totalResults":1,
"count":1,
"limit":100,
"offset":0,
"resultData":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"inventoryVersionStart":"2026-02-21T06:30:00Z",
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderVersionStart":"2026-02-21T06:30:00Z",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"DATA ENTRY ERROR",
"comment":"Created order item.",
"orderItemId":"5BB2C53538C841268AB4E4A1E640D0C9"
}
]
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
},
"400":{
"description":"Bad request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request parameters."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-inventory-audit-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-inventory-audit-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/allShipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/All shipments"
],
"summary":"v1.0",
"description":"Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded, BlindedDepot.",
"operationId":"getAllShipments",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-"
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"transactionId",
"in":"query",
"description":"String value for transaction ID of shipment.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8ECE2C9D389645B09740DC7926DEFB69"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponse"
},
"examples":{
"Get All Shipments Response":{
"description":"Get All Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"SHIP-0001",
"statusId":5,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-allShipments-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-allshipments-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/eligible-kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get eligible kits"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Searches for kits by kit type or shipment details. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getEligibleKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentEligibleKitsResponseV1"
},
"examples":{
"Get Eligible Kits Response":{
"description":"Get Eligible Kits Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":5,
"sequenceNumber":5,
"kitTypeName":"Kit A"
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-eligible-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-eligible-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-000123"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryDTOV1"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"C36A3197FDEE433FB5547EE83DE99E4B",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"SHIP-000123",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Order not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-shipmentid-get"
},
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Update shipment details for an order"
],
"summary":"v1.0",
"description":"Updates shipment details for an order. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"setOrderShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-000123"
}
],
"requestBody":{
"description":"Order shipment details.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/OrderShipmentDTO"
},
"examples":{
"Set Order Shipment Request":{
"description":"Set Order Shipment Request",
"value":{
"shipDate":"2026-02-24T00:00:00Z",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"deliveryNumber":"12345",
"updateDeliveryNumber":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"examples":{
"Set Order Shipment Response":{
"description":"Set Order Shipment Response",
"value":{
"status":"success",
"result":{
"shipmentId":"SHIP-000123",
"shipmentStatus":"SHIPPED"
},
"errorData":null,
"version":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"Invalid shipment type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-{shipmentId}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-shipmentid-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Searches for orders in a given date range matching a status. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"SHIPPED"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-01-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-01-31"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderInventoryDTOV1"
}
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"C36A3197FDEE433FB5547EE83DE99E4B",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"SHIP-000123",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request parameters."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get shipment by shipment ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves shipment by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentTO"
},
"examples":{
"Get Shipment Response":{
"description":"Get Shipment Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-000123",
"statusId":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipments",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"schema":{
"type":"string"
},
"example":"SHIP-"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"siteId",
"in":"query",
"description":"Site ID.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"statusId",
"in":"query",
"description":"Unique ID corresponding to each Order status value (1 for PENDING, 2 for IN TRANSIT, 3 for RECEIVED, 4 for CANCELLED, 5 for LOST, 6 for CONFIRMED, 7 for INVALID, 8 for PENDING DESTRUCTION, 9 for RECEIVED FOR DESTRUCTION, 10 for DESTROYED).",
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponse"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-000123",
"statusId":1,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipment-statuses":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/List available order status values"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves a list of available order status values. Rights: OrsInventoryGet.",
"operationId":"getStatuses",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderStatus"
}
},
"examples":{
"Get Shipment Statuses Response":{
"description":"Get Shipment Statuses Response",
"value":[
{
"id":1,
"status":"PENDING"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipment-statuses-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipment-statuses-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/cancel":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Cancel shipments"
],
"summary":"v1.0",
"description":"Cancels shipments in the system. Rights: OrsSupplyManagerPost, OrsUnblinded.",
"operationId":"markCancel",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Shipment IDs to be cancelled.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CancelShipmentRequest"
},
"examples":{
"Cancel Shipments Request":{
"description":"Cancel Shipments Request",
"value":{
"shipmentIds":[
"C36A3197FDEE433FB5547EE83DE99E4B",
"B1B8327AFAA6412287106192AB5984EF"
],
"toInventoryStatus":5
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"Cancel Shipments Response":{
"description":"Cancel Shipments Response",
"value":[
"C36A3197FDEE433FB5547EE83DE99E4B",
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"'Invalid order status', 'Invalid shipment type' or 'Invalid inventory status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-cancel-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-cancel-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/mark-lost":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Mark shipments as lost"
],
"summary":"v1.0",
"description":"Marks shipments as Lost in the system. Rights: OrsSupplyManagerPost, OrsUnblinded.",
"operationId":"markLost_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Shipment IDs to be marked as Lost.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LostShipmentRequest"
},
"examples":{
"Mark Shipments Lost Request":{
"description":"Mark Shipments Lost Request",
"value":{
"shipmentIds":[
"C36A3197FDEE433FB5547EE83DE99E4B",
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"Mark Shipments Lost Response":{
"description":"Mark Shipments Lost Response",
"value":[
"C36A3197FDEE433FB5547EE83DE99E4B",
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID, 'Study still in design phase', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"'Invalid order status' or 'Invalid shipment type'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-mark-lost-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-mark-lost-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/received":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Mark kits as received"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Marks kits as received in a study's inventory. Rights: OrsInventoryPost and DepotShipmentReceiptPost/OrsBlinded.",
"operationId":"markSiteOrDepotShipmentReceived",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Kits to be assigned.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedRequest"
},
"examples":{
"Mark Shipment Received Request":{
"description":"Mark Shipment Received Request",
"value":{
"receivedDate":"2026-02-24",
"updateNSKits":[
{
"inventoryStatusId":2,
"location":"SITE",
"lotId":"LOT-001",
"labelGroupId":"LABEL-GRP-001"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedResponse"
},
"examples":{
"Mark Shipment Received Response":{
"description":"Mark Shipment Received Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"status":"RECEIVED"
}
}
}
}
}
},
"400":{
"description":"'Invalid order status', 'Invalid kit'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-received-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-received-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/quarantined":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Quarantine/Update shipment and its kits as quarantined"
],
"summary":"v1.0",
"description":"Updates the shipment and its kits as quarantined. Rights: OrsInventoryPost, DepotShipmentReceiptPost/OrsBlinded.",
"operationId":"quarantineShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Quarantine shipment request body.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentQuarantineRequestV1"
},
"examples":{
"Quarantine Shipment Request":{
"description":"Quarantine Shipment Request",
"value":{
"tempMonitorStatus":"missing"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Quarantine Shipment Response":{
"description":"Quarantine Shipment Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Quarantine Shipment Server Error Response":{
"description":"Quarantine Shipment Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"quarantineShipment",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Quarantine Shipment Not Found Response":{
"description":"Quarantine Shipment Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"reason":"No shipment matched the supplied identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"'Invalid Kit', 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Quarantine Shipment Bad Request Response":{
"description":"Quarantine Shipment Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid shipment quarantine request.",
"details":{
"field":"tempMonitorStatus",
"issue":"Allowed values are yes, no, or missing."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-quarantined-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-quarantined-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/receive-quarantined":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Quarantine/Update a quarantined shipment and its kits to received"
],
"summary":"v1.0",
"description":"Updates a quarantine shipment and its kits. Rights: DepotQuarantinePost.",
"operationId":"quarantinedShipmentToReceived",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Kits to be damaged.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/QuarantinedToReceivedRequest"
},
"examples":{
"Receive Quarantined Shipment Request":{
"description":"Receive Quarantined Shipment Request",
"value":{
"damagedKits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"updateNSKits":[
{
"lotId":"D313327EF13845169A8ADADDA435431E",
"kitTypeId":"89EE76326E984B548D594D592E5C7FC2",
"inventoryStatusId":2,
"quantity":5
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/QuarantinedToReceivedResponseV1"
},
"examples":{
"Receive Quarantined Shipment Response":{
"description":"Receive Quarantined Shipment Response",
"value":{
"receivedDate":"2026-02-24T00:00:00Z",
"availableCount":98,
"damagedCount":2
}
}
}
}
}
},
"400":{
"description":"'Invalid Kit', 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Receive Quarantined Shipment Bad Request Response":{
"description":"Receive Quarantined Shipment Bad Request Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"field":"damagedKits",
"issue":"One or more kits do not belong to the quarantined shipment."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Receive Quarantined Shipment Not Found Response":{
"description":"Receive Quarantined Shipment Not Found Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"reason":"No shipment matched the supplied identifier."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Receive Quarantined Shipment Server Error Response":{
"description":"Receive Quarantined Shipment Server Error Response",
"value":{
"status":"ERROR",
"version":1,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"quarantinedShipmentToReceived",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-receive-quarantined-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-receive-quarantined-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/regenerate-order-form":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Forms/Regenerate order form"
],
"summary":"v1.0",
"description":"Regenerates order form of a shipment by shipment ID. Rights: BlindedKitOrderFormReportPost.",
"operationId":"regenerateOrderForm",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RegenerateOrderFormResponse"
}
},
"examples":{
"Regenerate Order Form Response":{
"description":"Regenerate Order Form Response",
"value":[
{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"status":"QUEUED"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID OR Invalid shipment ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"Invalid shipment status OR Invalid shipment type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-regenerate-order-form-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-regenerate-order-form-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/removeKits":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Remove kits from a shipment"
],
"summary":"v1.0",
"description":"Removes kits from an order shipment. Rights: OrsInventoryDelete, OrsUnblinded.",
"operationId":"removeKitsFromShipmentPost",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Kits to be removed from the shipment.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentRemoveKitsRequest"
},
"examples":{
"Remove Kits From Shipment Request":{
"description":"Remove Kits From Shipment Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Remove Kits Response":{
"description":"Remove Kits Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"'Invalid Kit', 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-removeKits-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-removekits-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/orders/{shipmentId}/confirmed":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Confirm order shipment"
],
"summary":"v1.0",
"description":"Confirms an order shipment. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"setOrderShipmentConfirmed",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-000123"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"examples":{
"Set Order Shipment Confirmed Response":{
"description":"Set Order Shipment Confirmed Response",
"value":{
"status":"success",
"result":{
"shipmentId":"SHIP-000123",
"shipmentStatus":"CONFIRMED"
},
"errorData":null,
"version":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"Invalid shipment type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-{shipmentId}-confirmed-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-shipmentid-confirmed-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/orders/{shipmentId}/invalid":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Invalidate order shipment"
],
"summary":"v1.0",
"description":"Invalidates an order shipment. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"setOrderShipmentInvalid",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-000123"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"examples":{
"Set Order Shipment Invalid Response":{
"description":"Set Order Shipment Invalid Response",
"value":{
"status":"success",
"result":{
"shipmentId":"SHIP-000123",
"shipmentStatus":"INVALID"
},
"errorData":null,
"version":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"Invalid shipment type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-orders-{shipmentId}-invalid-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-orders-shipmentid-invalid-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/received-date":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Update received date"
],
"summary":"v1.0",
"description":"Updates received date for a shipment. Rights: ShipmentReceivedDatePut.",
"operationId":"updateReceivedDate_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Shipment received date parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedDateRequest"
},
"examples":{
"Update Shipment received Date Request":{
"description":"Update Shipment received Date Request",
"value":{
"receivedDate":"2026-02-24"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Update Received Date Response":{
"description":"Update Received Date Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"'Invalid received date' or 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid received date."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-received-date-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-received-date-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/ship-date":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Update shipping date"
],
"summary":"v1.0",
"description":"Updates shipping date for a shipment. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"updateShipDate_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Shipment ship date parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentShipDateRequest"
},
"examples":{
"Update Shipment Ship Date Request":{
"description":"Update Shipment Ship Date Request",
"value":{
"shipDate":"2026-02-24"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Update Ship Date Response":{
"description":"Update Ship Date Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"'Invalid shipped date' or 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid ship date."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-ship-date-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-ship-date-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/shipments/{shipmentId}/tracking":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Tracking/Update tracking details for an order shipment"
],
"summary":"v1.0",
"description":"Updates tracking details for an order shipment. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"updateTrackingDetails_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Shipment Tracking Details parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentTrackingDetailsRequest"
},
"examples":{
"Update Tracking Details Request":{
"description":"Update Tracking Details Request",
"value":{
"trackingNumber":"1Z9999999999999999",
"trackingNumberUrl":"https://www.ups.com/track"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Update Tracking Details Response":{
"description":"Update Tracking Details Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-shipments-{shipmentId}-tracking-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-shipments-shipmentid-tracking-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/received/kits":{
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Update status of a received kit"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Updates the status of a received kit in the system. Rights: OrsSupplyManagerPost and OrsBlinded.",
"operationId":"updateReceivedKitsStatus",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Kits to be updated along with the new status value.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentUpdateKitsRequest"
},
"examples":{
"Update Received Kits Status Request":{
"description":"Update Received Kits Status Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"toInventoryStatus":2
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedResponse"
},
"examples":{
"Update Received Kits Status Response":{
"description":"Update Received Kits Status Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"receivedDate":"2026-02-24T06:30:00Z",
"damagedCount":0,
"missingCount":0,
"preQuarantinedCount":1,
"availableCount":4
}
}
}
}
}
},
"400":{
"description":"'Invalid order status', 'Invalid kit', 'Invalid inventory status value'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid update request."
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Shipment not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-received-kits-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-received-kits-put"
},
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Add additional kits to a received shipment"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Adds additional kits to a received shipment in the system. Rights: OrsSupplyManagerPost and OrsBlinded.",
"operationId":"addKitsToReceivedShipment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Kits to be added to the shipment.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentAddKitsRequest"
},
"examples":{
"Add Kits To Shipment Request":{
"description":"Add Kits To Shipment Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Add Kits To Shipment Response":{
"description":"Add Kits To Shipment Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"400":{
"description":"'Invalid kit', 'Invalid shipment status value'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid add kits request."
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Shipment not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-received-kits-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-received-kits-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/received/eligible-kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits eligible to be received against a shipment"
],
"summary":"v1.0",
"description":"Retrieves all kits eligible to be received against a shipment. Rights: OrsSupplyManagerGet and OrsBlinded.",
"operationId":"getEligibleKitsForReceived",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentRecvEligibleKitsResponse"
},
"examples":{
"Get Eligible Kits For Received Response":{
"description":"Get Eligible Kits For Received Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
]
}
}
}
}
}
},
"400":{
"description":"Invalid shipment type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid request."
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Shipment not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-received-eligible-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-received-eligible-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits or a specific kit for a shipment"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves either all kits or a specific kit (if kit number is provided) for a shipment. Rights: OrsSupplyManagerGet and OrsBlinded.",
"operationId":"getSiteKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-000123"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteShipmentKitsTO"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"kits":[
],
"paging":{
"offset":0,
"limit":100,
"total":0
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Shipment not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/received":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Mark kits as received for a given site"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Marks kits as Received in a site's inventory for a given study. Rights: OrsSupplyManagerPost and OrsBlinded.",
"operationId":"markReceived",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Kits to be assigned.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedRequest"
},
"examples":{
"Mark Shipment Received Request":{
"description":"Mark Shipment Received Request",
"value":{
"receivedDate":"2026-02-24",
"updateNSKits":[
{
"inventoryStatusId":2,
"location":"SITE",
"lotId":"LOT-001",
"labelGroupId":"LABEL-GRP-001"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedResponse"
},
"examples":{
"Mark Shipment Received Response":{
"description":"Mark Shipment Received Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"receivedDate":"2026-02-24T06:30:00Z",
"damagedCount":0,
"missingCount":0,
"preQuarantinedCount":1,
"availableCount":4
}
}
}
}
}
},
"400":{
"description":"'Invalid order status', 'Invalid kit'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid received request."
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Shipment not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-received-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-received-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get a shipment's details by ID for a site"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a shipment's details by ID for a site. Rights: OrsSupplyManagerGet and OrsBlinded.",
"operationId":"getShipment_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserShipmentTOV2"
},
"examples":{
"Get Site Shipment Response":{
"description":"Get Site Shipment Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Shipment not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a site"
],
"summary":"v2.0",
"description":"Searches for shipments associated with a site by site ID. Rights: OrsSupplyManagerGet and OrsBlinded.",
"operationId":"getShipments_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV2"
},
"examples":{
"Get Site Shipments Response":{
"description":"Get Site Shipments Response",
"value":{
"shipments":[
{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"No shipments found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-shipments-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits or a specific kit for a shipment"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves either all kits or a specific kit (if a kit number is provided) for a shipment. Rights: OrsSupplyManagerGet and OrsBlinded. Adds fields to return the kit description and packaging type.",
"operationId":"getSiteKits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-000123"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteShipmentKitsTOV2"
},
"examples":{
"Get Site Shipment Kits Response":{
"description":"Get Site Shipment Kits Response",
"value":{
"kits":[
{
"kitNumber":"KIT-000123"
}
]
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"No kits found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-kits-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/received":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Mark kits as received for a given site"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Marks kits as Received in a site's inventory for a given study. Rights: OrsSupplyManagerPost and OrsBlinded.",
"operationId":"markReceived_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Kits to be assigned.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedRequest"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedResponse"
},
"examples":{
"Mark Shipment Received Response":{
"description":"Mark Shipment Received Response",
"value":{
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"status":"RECEIVED"
}
}
}
}
}
},
"400":{
"description":"'Invalid order status', 'Invalid kit'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid received request."
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Shipment not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-received-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-received-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/resupply/manual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Initiate manual resupply to a site"
],
"summary":"v2.0",
"description":"Initiates manual resupply to a site. Rights: OrsSupplyManagerPost and OrsBlinded.",
"operationId":"siteInitiatedManualResupply",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"SiteID and reason to request manual resupply.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteManualResupplyRequest"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ResupplyResponse"
}
},
"examples":{
"Site Initiated Manual Resupply Response":{
"description":"Site Initiated Manual Resupply Response",
"value":[
{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
}
}
}
},
"400":{
"description":"Manual shipment is not allowed for this study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid manual resupply request."
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Site not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-resupply-manual-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-resupply-manual-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/studyversions/{version}":{
"put":{
"tags":[
"Randomization and Supplies/Study Import APIs/Update study version"
],
"summary":"v1.0",
"description":"Updates a study's version. Rights: OrsImportDesignPost.",
"operationId":"updateStudyVersion",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"version",
"in":"path",
"description":"Version of the study.",
"required":true,
"schema":{
"type":"string"
},
"example":1
}
],
"requestBody":{
"description":"Study version parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyVersionRequest"
},
"examples":{
"Update Study Version Request":{
"description":"Update Study Version Request",
"value":{
"version":"1.0.0.6"
}
}
}
}
},
"required":true
},
"responses":{
"204":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Update Study Version Response":{
"description":"Update Study Version Response",
"value":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Study Version Server Error Response":{
"description":"Update Study Version Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"STUDY-500",
"errorMessage":"Unexpected error while updating study version."
}
}
}
}
}
}
},
"404":{
"description":"Study version not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Study Version Not Found Response":{
"description":"Update Study Version Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"STUDY-404",
"errorMessage":"Study version not found."
}
}
}
}
}
}
},
"400":{
"description":"Invalid study version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Study Version Bad Request Response":{
"description":"Update Study Version Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"STUDY-400",
"errorMessage":"Invalid study version update request."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-studyversions-{version}-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-studyversions-version-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/{siteId}/subjects":{
"get":{
"tags":[
"Randomization and Supplies/Subject APIs/Get a list of all subjects"
],
"summary":"v1.0",
"description":"Retrieves a list of all subjects based on study ID and site ID. Rights: DataCaptureSubjectGet.",
"operationId":"getDCSSubjects",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DCSSubject"
}
},
"examples":{
"Get DCS Subjects Response":{
"description":"Get DCS Subjects Response",
"value":[
{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"screeningNumber":"SCR-0001"
}
]
}
}
}
}
},
"404":{
"description":"The study identifier does not match any study identifiers in Clinical One or site not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"No subjects found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-{siteId}-subjects-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-siteid-subjects-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/randomized":{
"get":{
"tags":[
"Randomization and Supplies/Subject APIs/Get a list of all randomized subjects"
],
"summary":"v1.0",
"description":"Retrieves a list of all randomized subjects in a study. Rights: DataCaptureSubjectGet.",
"operationId":"getRandomizedSubjects",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DCSSubject"
}
},
"examples":{
"Get Randomized Subjects Response":{
"description":"Get Randomized Subjects Response",
"value":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionStart":"2026-02-21T06:45:00Z",
"description":"Subject randomized into Treatment Arm A.",
"subjectNumber":"SUBJ-001",
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"siteId":"82558921FCF14D2E9DA23FEDD57DDF7C",
"dob":"1989-05-14",
"screeningDate":"2026-02-14",
"state":"Active",
"stateDate":"2026-02-21",
"informedConsentDate":"2026-02-10",
"gender":"Female",
"subjectTransferId":"E413327EF13845169A8ADADDA435431F",
"studyVersion":"1.0.0.5",
"codeBreak":"Treatment arm A",
"mhealthSubjectId":"F513327EF13845169A8ADADDA4354320",
"randomized":true
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SUBJECT-500",
"errorMessage":"Unexpected error while retrieving randomized subjects.",
"details":{
"operation":"getRandomizedSubjects",
"reason":"The randomized subject lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-randomized-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-randomized-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/visits/{visitId}/status":{
"get":{
"tags":[
"Randomization and Supplies/Subject APIs/Retrieves the visit date for a particular subject ID and visit ID"
],
"summary":"v1.0",
"description":"Retrieves the visit date for completed visits; null for visits not completed.",
"operationId":"getSubjectVisitStatus",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"path",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number of the unscheduled visit",
"schema":{
"type":"integer",
"format":"int32"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse"
},
"examples":{
"Get Subject Visit Status Response":{
"description":"Get Subject Visit Status Response",
"value":{
"subjects":[
{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visits":[
{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"versionStart":"2026-02-24T09:15:00Z",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"eventId":"B1B8327AFAA6412287106192AB5984EF",
"siteId":"82558921FCF14D2E9DA23FEDD57DDF7C",
"studyVersion":"1.0.0.5",
"visitStatus":"COMPLETE",
"reason":"Subject completed the visit successfully",
"comment":"All required visit data was entered and verified.",
"visitStartDate":"2026-02-24T09:00:00Z",
"visitType":"DISPENSATION",
"eventType":"Visit_Complete"
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SUBJECT-500",
"errorMessage":"Unexpected error while retrieving subject visit status.",
"details":{
"operation":"getSubjectVisitStatus",
"reason":"The subject visit status lookup failed."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SUBJECT-400",
"errorMessage":"The subject visit status request is invalid.",
"details":{
"field":"instanceNumber",
"reason":"Instance number cannot be negative."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-visits-{visitId}-status-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-visits-visitid-status-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/titration-impact":{
"get":{
"tags":[
"Randomization and Supplies/Subject APIs/Check if titration has any impact on kit dispensation"
],
"summary":"v1.0",
"description":"Checks whether titration has any impact on kit dispensation or not. Rights: OrsRandListGet.",
"operationId":"getTitrationImpact",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"treatmentId",
"in":"query",
"description":"Treatment ID of the subject.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/TitrationImpactTO"
},
"examples":{
"Get Titration Impact Response":{
"description":"Get Titration Impact Response",
"value":{
"impact":true
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SUBJECT-500",
"errorMessage":"Unexpected error while evaluating titration impact.",
"details":{
"operation":"getTitrationImpact",
"reason":"The titration impact check failed."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SUBJECT-400",
"errorMessage":"The titration impact request is invalid.",
"details":{
"field":"subjectId",
"reason":"The subject is invalid or not randomized."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-titration-impact-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-titration-impact-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/supply/settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Get supply settings"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Retrieves supply settings by study ID.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsGet.",
"operationId":"getSupplySettings_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV1"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Supply Settings Server Error Response":{
"description":"Get Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-500",
"errorMessage":"Unexpected error while retrieving supply settings.",
"details":{
"operation":"getSupplySettings",
"reason":"The supply settings lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-supply-settings-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-supply-settings-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Updates supply settings of a study by study ID.
Rights: SupplySettingRightsPost.
Required sponsor roles are: clinical supply manager and site manager.",
"operationId":"updateSupplySettings",
"parameters":[
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV1"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Not Found Response":{
"description":"Update Supply Settings Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-404",
"errorMessage":"Supply settings were not found for the study.",
"details":{
"field":"studyId",
"reason":"The supplied study identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Bad Request Response":{
"description":"Update Supply Settings Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-400",
"errorMessage":"The supply settings update request is invalid.",
"details":{
"field":"shipmentPrefixType",
"reason":"The shipment prefix type must be DEPOTID, CUSTOM, or NONE."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Server Error Response":{
"description":"Update Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-500",
"errorMessage":"Unexpected error while updating supply settings.",
"details":{
"operation":"updateSupplySettings",
"reason":"The supply settings update failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/supply/settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Get supply settings"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Use latest version instead. Retrieves supply settings.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsGet.",
"operationId":"getSupplySettings_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV2"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Supply Settings Server Error Response":{
"description":"Get Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-500",
"errorMessage":"Unexpected error while retrieving supply settings.",
"details":{
"operation":"getSupplySettings",
"reason":"The supply settings lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-supply-settings-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-supply-settings-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Use latest version instead. Updates a study's supply settings by study ID.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"SupplySettingTO parameter.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV2"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"B1B8327AFAA6412287106192AB5984EF",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Not Found Response":{
"description":"Update Supply Settings Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-404",
"errorMessage":"Supply settings were not found for the study.",
"details":{
"field":"studyId",
"reason":"The supplied study identifier does not exist."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Bad Request Response":{
"description":"Update Supply Settings Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-400",
"errorMessage":"The supply settings update request is invalid.",
"details":{
"field":"shipmentPrefixType",
"reason":"The shipment prefix type must be DEPOTID, CUSTOM, or NONE."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Server Error Response":{
"description":"Update Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SETTINGS-500",
"errorMessage":"Unexpected error while updating supply settings.",
"details":{
"operation":"updateSupplySettings",
"reason":"The supply settings update failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/titration-eligible":{
"get":{
"tags":[
"Randomization and Supplies/Titration APIs/Check if subject is eligible for titration"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Checks if subject is eligible for titration. This is a new version of the API for returning additional attributes for titration kit label. Rights: OrsSubjectVisitGet.",
"operationId":"isTitrationAllowedForSubject",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"query",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitKitTypeTO"
}
},
"examples":{
"Titration Eligible Response":{
"description":"Titration Eligible Response",
"value":[
{
"kitTypeId":"B1B8327AFAA6412287106192AB5984EF",
"kitsDispensed":2
}
]
}
}
}
}
},
"400":{
"description":"For a subject who cannot be titrated as there are no titration kits dispensed to the subject earlier OR Subject cannot be titrated as no matching kits are defined with subject dispensations. ORInvalid subject OR Missing subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request Response":{
"description":"Bad Request Response",
"value":{
"error":{
"message":"Invalid titration eligible request."
}
}
}
}
}
}
},
"404":{
"description":"Visit not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found Response":{
"description":"Not Found Response",
"value":{
"error":{
"message":"Subject not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error Response":{
"description":"Server Error Response",
"value":{
"error":{
"message":"Unexpected error."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-titration-eligible-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-titration-eligible-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/allowed-doseholds":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get kits allowed for dose hold"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Get kits allowed for dose hold in the current visit for a given subject. Rights: OrsSubjectVisitGet.",
"operationId":"getAllowedDoseHold",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"query",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.5"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldKitsResponse"
},
"examples":{
"Allowed Dose Hold Response":{
"description":"Allowed Dose Hold Response",
"value":{
"status":"ALLOW_DOSE_HOLD",
"kitsAllowedForDoseHold":[
{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"trialSupplyType":"BOTTLE",
"deviceType":"ActivityWatch",
"blindedTItrationLabel":"Low dose",
"isTitration":true,
"reason":null
}
],
"kitsNotAllowedForDoseHold":[
{
"kitTypeSrcId":"E413327EF13845169A8ADADDA435431F",
"kitDescription":"Kit B",
"trialSupplyType":"DEVICE",
"deviceType":"Spirometer",
"blindedTItrationLabel":"Maintenance dose",
"isTitration":false,
"reason":"DOSE_HOLD_VISIT_NOT_STARTED"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Allowed Dose Hold Bad Request Response":{
"description":"Allowed Dose Hold Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The allowed dose hold request is invalid.",
"details":{
"field":"studyVersion",
"reason":"The study version is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Allowed Dose Hold Server Error Response":{
"description":"Allowed Dose Hold Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving dose hold eligibility.",
"details":{
"operation":"getAllowedDoseHold",
"reason":"The dose hold eligibility lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-allowed-doseholds-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-allowed-doseholds-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/codebreak":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get code break"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves code break. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeBreak",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Code view parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewRequest"
},
"examples":{
"Code Break Request":{
"description":"Code Break Request",
"value":{
"adverseEvent":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewResponse"
},
"examples":{
"Code Break Response":{
"description":"Code Break Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"description":"Randomized successfully",
"externalTreatmentId":"TA",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4
}
],
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":2,
"packageType":"BOTTLE"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found. Or site ID not found in site service",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Not Found Response":{
"description":"Code Break Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Code break information was not found for the subject.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have code break data."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Bad Request Response":{
"description":"Code Break Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The code break request is invalid.",
"details":{
"field":"adverseEvent",
"reason":"The adverse event flag must be 0 or 1."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Server Error Response":{
"description":"Code Break Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving code break information.",
"details":{
"operation":"getCodeBreak",
"reason":"The code break lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-codebreak-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-srcsubjectid-codebreak-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/codeview":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get code view"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves code view. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeView",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Code view parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewRequest"
},
"examples":{
"Code View Request":{
"description":"Code View Request",
"value":{
"adverseEvent":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewResponse"
},
"examples":{
"Code View Response":{
"description":"Code View Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"description":"Randomized successfully",
"externalTreatmentId":"TA",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4
}
],
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":2,
"packageType":"BOTTLE"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Not Found Response":{
"description":"Code View Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Code view information was not found for the subject.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have code view data."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Bad Request Response":{
"description":"Code View Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The code view request is invalid.",
"details":{
"field":"adverseEvent",
"reason":"The adverse event flag must be 0 or 1."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Server Error Response":{
"description":"Code View Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving code view information.",
"details":{
"operation":"getCodeView",
"reason":"The code view lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-codeview-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-srcsubjectid-codeview-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: ",
"operationId":"getDispensationHistory",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"externalSubjectId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"visitId",
"in":"query",
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponse"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":10001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:45:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitDescription":"Bottle of tablets"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Not Found Response":{
"description":"Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No dispensation history was found for the subject visit.",
"details":{
"field":"externalSubjectId",
"reason":"The subject does not have dispensation history for the supplied visit."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Bad Request Response":{
"description":"Dispensation History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The dispensation history request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Server Error Response":{
"description":"Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving dispensation history.",
"details":{
"operation":"getDispensationHistory",
"reason":"The dispensation history lookup could not be completed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/visits/{visitId}":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation info for a subject"
],
"summary":"v1.0",
"description":"Retrieves dispensation info of the most recent dispensation or all previous dispensations for a study by subject and visit ID. Rights: OrsUnblinded.",
"operationId":"getDispensationInfo",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"path",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"dispensationInfo",
"in":"query",
"description":"Dispensation info required [last/previous]",
"required":true,
"schema":{
"type":"string"
},
"example":true
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
}
},
{
"name":"includeUnScheduledVisits",
"in":"query",
"description":"Include unscheduled visits [Y/N]",
"schema":{
"type":"string"
}
},
{
"name":"includeReplacementVisits",
"in":"query",
"description":"Include replacement visits [Y/N]",
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationInfoResponse"
}
},
"examples":{
"Dispensation Info Response":{
"description":"Dispensation Info Response",
"value":[
{
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"visitName":"Week1",
"eventInstanceNumber":2,
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"kitType":"KitA",
"kitDescription":"Kit A description paracetamol 5mg",
"dateDispensed":"2026-02-21T06:45:00Z",
"dosage":0.5,
"quantity":3,
"isHeld":false
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or visit ID OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation Info Not Found Response":{
"description":"Dispensation Info Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Dispensation information was not found for the subject visit.",
"details":{
"field":"visitId",
"reason":"The subject does not have dispensation information for the supplied visit."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation Info Bad Request Response":{
"description":"Dispensation Info Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The dispensation info request is invalid.",
"details":{
"field":"dispensationInfo",
"reason":"The dispensation info flag must be true."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation Info Server Error Response":{
"description":"Dispensation Info Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving dispensation information.",
"details":{
"operation":"getDispensationInfo",
"reason":"The dispensation information lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-visits-{visitId}-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-visits-visitid-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/doseheld-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dose hold history"
],
"summary":"v1.0",
"description":"Get dose hold history for current subject. Rights: OrsSubjectVisitGet",
"operationId":"getDoseHeldHistory",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDoseHeldHistoryTO"
},
"examples":{
"Dose Held History Response":{
"description":"Dose Held History Response",
"value":[
{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"canBeDispensed":true,
"objectVersionNumber":5,
"userId":"A1B8327AFAA6412287106192AB5984EF",
"versionStart":"2026-02-21T06:45:00Z",
"versionEnd":"2026-02-28T06:45:00Z",
"instanceNumber":2
}
]
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held History Bad Request Response":{
"description":"Dose Held History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The dose held history request is invalid.",
"details":{
"field":"subjectId",
"reason":"The subject identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held History Server Error Response":{
"description":"Dose Held History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving dose held history.",
"details":{
"operation":"getDoseHeldHistory",
"reason":"The dose held history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-doseheld-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-doseheld-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subject-doseholds":{
"post":{
"tags":[
"Randomization and Supplies/Dose Hold Subject Visits APIs/Get visits on dose hold for all subjects"
],
"summary":"v1.0",
"description":"Retrieves the visits marked with dose hold for all subjects.",
"operationId":"getDoseholdSubjectVisits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Subjects list parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseholdSubjectsRequestV1"
},
"examples":{
"Dose Hold Subjects Request":{
"description":"Dose Hold Subjects Request",
"value":{
"subjects":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseholdSubjectsResponseV1"
},
"examples":{
"Dose Hold Subjects Response":{
"description":"Dose Hold Subjects Response",
"value":{
"subjects":[
{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1
}
]
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subject-doseholds-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subject-doseholds-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/locally-sourced-kits":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Local Source Settings/Get local source settings for a Subject ID"
],
"summary":"v1.0",
"description":"Retrieves locally sourced kit settings for a Subject ID.",
"operationId":"getLocallySourcedKitSettings_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"schema":{
"type":"string"
}
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
}
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/LocallySourceKitsResponseV1"
}
},
"examples":{
"Locally Sourced Kits Response":{
"description":"Locally Sourced Kits Response",
"value":[
{
"kitDescription":"Locally sourced inhaler",
"deviceType":"Spirometer",
"deviceConnection":"DevicetoCloud",
"trialSupplyType":"DEVICE",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"userId":"A1B8327AFAA6412287106192AB5984EF",
"dispensationDate":"2026-02-21T06:45:00Z",
"quantity":1
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Locally Sourced Kits Server Error Response":{
"description":"Locally Sourced Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving locally sourced kits.",
"details":{
"operation":"getLocallySourcedKitSettings",
"reason":"The locally sourced kits lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-locally-sourced-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-externalsubjectid-locally-sourced-kits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subject-partial-dispensations":{
"post":{
"tags":[
"Randomization and Supplies/Partial Dispensation Subject Visits APIs/Get visits with partial dispensation for all subjects"
],
"summary":"v1.0",
"description":"Retrieves visits marked with partial dispensation for all subjects",
"operationId":"getPartialDispensationSubjectVisits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Subjects list parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PartialDispensationSubjectsRequestV1"
},
"examples":{
"Partial Dispensation Subjects Request":{
"description":"Partial Dispensation Subjects Request",
"value":{
"subjects":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PartialDispensationSubjectsResponseV1"
},
"examples":{
"Partial Dispensation Subjects Response":{
"description":"Partial Dispensation Subjects Response",
"value":{
"subjects":[
{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"dispensationAllowed":true,
"visitDate":"2026-02-21T06:45:00Z"
}
]
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subject-partial-dispensations-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subject-partial-dispensations-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/randomization-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get randomization history"
],
"summary":"v1.0",
"description":"Retrieves randomization history. Rights: OrsSubjectVisitGet.",
"operationId":"getRandomizationHistory",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationHistoryResponse"
}
},
"examples":{
"Randomization History Response":{
"description":"Randomization History Response",
"value":[
{
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z"
},
{
"randNumber":1002,
"randomizationDate":"2026-02-28T09:30:00Z"
}
]
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Randomization History Not Found Response":{
"description":"Randomization History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Randomization history was not found for the subject.",
"details":{
"field":"externalSubjectId",
"reason":"The subject does not have randomization history."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Randomization History Server Error Response":{
"description":"Randomization History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving randomization history.",
"details":{
"operation":"getRandomizationHistory",
"reason":"The randomization history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-randomization-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-externalsubjectid-randomization-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/reuse-kits":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get reusable kits"
],
"summary":"v1.0",
"description":"Get previously dispensed kits that can be reused in the current visit for a given subject. Rights: OrsSubjectVisitGet.",
"operationId":"getReusableKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"query",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.5"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"titrationOption",
"in":"query",
"description":"Titration options to dispense kits. For example: up/down/maintain.",
"schema":{
"type":"string"
},
"example":"up"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReusableKitsResponseV1"
},
"examples":{
"Reusable Kits Response":{
"description":"Reusable Kits Response",
"value":{
"status":"ALLOW",
"kits":[
{
"id":2,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"consumeAcrossDoses":true,
"dose":5,
"measurement":"mg",
"frequency":"QD",
"kitDescription":"Kit A"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Bad Request Response":{
"description":"Reusable Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The reusable kits request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Server Error Response":{
"description":"Reusable Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving reusable kits.",
"details":{
"operation":"getReusableKits",
"reason":"The reusable kit lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-reuse-kits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-reuse-kits-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get reusable kits from a list of kit types"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves previously dispensed kits, from a list of kit types passed in the request body, that can be reused in the current visit for a given subject. Rights: OrsSubjectVisitGet.",
"operationId":"getReusableDoseHoldKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Contains details for getting reusable kits.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDoseHoldRequest"
},
"examples":{
"Reusable Dose Hold Kits Request":{
"description":"Reusable Dose Hold Kits Request",
"value":{
"studyVersion":"1.0.0.5",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":2,
"titrationOption":"up",
"kitTypesForDoseHold":[
{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"deviceType":"Spirometer",
"isTitration":true
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReusableKitsResponseV1"
},
"examples":{
"Reusable Dose Hold Kits Response":{
"description":"Reusable Dose Hold Kits Response",
"value":{
"status":"ALLOW",
"kits":[
{
"id":2,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"consumeAcrossDoses":true,
"dose":5,
"measurement":"mg",
"frequency":"QD",
"kitDescription":"Kit A"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Dose Hold Kits Bad Request Response":{
"description":"Reusable Dose Hold Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The reusable dose hold kits request is invalid.",
"details":{
"field":"kitTypesForDoseHold",
"reason":"At least one kit type is required."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Dose Hold Kits Server Error Response":{
"description":"Reusable Dose Hold Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving reusable dose hold kits.",
"details":{
"operation":"getReusableDoseHoldKits",
"reason":"The reusable dose hold kit lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-reuse-kits-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-reuse-kits-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subject/{subjectId}/details":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get treatment arm and cohort for a subject"
],
"summary":"v1.0",
"description":"Retrieves a subject's treatment arm and cohort. Rights: DataCaptureSubjectGet, ORSUnblinded.",
"operationId":"getSubjectDetails",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectTrtArmResponseV1"
},
"examples":{
"Subject Details Response":{
"description":"Subject Details Response",
"value":{
"treatmentId":"B1B8327AFAA6412287106192AB5984EF",
"cohortId":"D313327EF13845169A8ADADDA435431E",
"randomizationDate":"2023-07-26T10:43:40.494Z"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Details Not Found Response":{
"description":"Subject Details Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Subject details were not found.",
"details":{
"field":"subjectId",
"reason":"The subject does not have treatment details."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Details Server Error Response":{
"description":"Subject Details Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving subject details.",
"details":{
"operation":"getSubjectDetails",
"reason":"The subject details lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subject-{subjectId}-details-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subject-subjectid-details-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/treatment":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get subject treatment"
],
"summary":"v1.0",
"description":"Retrieves a subject's treatment. Rights: OrsSubjectVisitGet.",
"operationId":"getSubjectTreatment",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectTreatmentResponse"
},
"examples":{
"Subject Treatment Response":{
"description":"Subject Treatment Response",
"value":{
"treatmentId":"B1B8327AFAA6412287106192AB5984EF",
"treatmentTitle":"TA"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Treatment Not Found Response":{
"description":"Subject Treatment Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Treatment information was not found for the subject.",
"details":{
"field":"subjectId",
"reason":"The subject does not have treatment details."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Treatment Bad Request Response":{
"description":"Subject Treatment Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The subject treatment request is invalid.",
"details":{
"field":"subjectId",
"reason":"The subject identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Invalid treatment found for the subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Treatment Server Error Response":{
"description":"Subject Treatment Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving subject treatment information.",
"details":{
"operation":"getSubjectTreatment",
"reason":"The subject treatment lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-treatment-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-treatment-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{subjectId}/doseheld":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get kits which are marked as dose hold"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Get kits which are marked as dose hold in the current visit. Rights: OrsSubjectVisitGet.",
"operationId":"getSubjectVisitDoseHeldKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldKit"
},
"examples":{
"Dose Held Kits Response":{
"description":"Dose Held Kits Response",
"value":{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"trialSupplyType":"BOTTLE",
"deviceType":"ActivityWatch",
"blindedTItrationLabel":"Low dose",
"isTitration":true,
"reason":null
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held Kits Bad Request Response":{
"description":"Dose Held Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The dose held kits request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held Kits Server Error Response":{
"description":"Dose Held Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving dose held kits.",
"details":{
"operation":"getSubjectVisitDoseHeldKits",
"reason":"The dose held kit lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{subjectId}-doseheld-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-subjectid-doseheld-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subject-treatment":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get treatment arm for a list of subjects IDs"
],
"summary":"v1.0",
"description":"Retrieves a subject's treatment. Rights: DataCaptureSubjectGet.",
"operationId":"getSubjectsTrtArm",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"id",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectTrtArmResponseV1"
},
"examples":{
"Subject Treatment By IDs Response":{
"description":"Subject Treatment By IDs Response",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"treatmentId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Treatment By IDs Not Found Response":{
"description":"Subject Treatment By IDs Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Treatment information was not found for the subject list.",
"details":{
"field":"id",
"reason":"No matching subjects were found."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Treatment By IDs Server Error Response":{
"description":"Subject Treatment By IDs Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving subject treatment information.",
"details":{
"operation":"getSubjectsTrtArm",
"reason":"The subject treatment lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subject-treatment-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subject-treatment-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get treatment arm for a list of subjects"
],
"summary":"v1.0",
"description":"Retrieves treatment arms for a list of subjects in a study, passed in the request body. Rights: DataCaptureSubjectGet.",
"operationId":"getSubjectsTreatArm",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Subjects list parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectsRequestV1"
},
"examples":{
"Subject Treatment Request":{
"description":"Subject Treatment Request",
"value":{
"subjects":[
"C36A3197FDEE433FB5547EE83DE99E4B",
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectTrtArmResponseV1"
},
"examples":{
"Subject Treatment Request Response":{
"description":"Subject Treatment Request Response",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"treatmentId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Treatment Request Not Found Response":{
"description":"Subject Treatment Request Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Treatment information was not found for the subject list.",
"details":{
"field":"subjects",
"reason":"No matching subjects were found."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Treatment Request Server Error Response":{
"description":"Subject Treatment Request Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving subject treatment information.",
"details":{
"operation":"getSubjectsTreatArm",
"reason":"The subject treatment lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subject-treatment-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subject-treatment-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/unblinded-disp-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded dispensation history for all subjects"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Retrieves unblinded dispensation history for all subjects within the study. Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedAllDispHistory",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"schema":{
"type":"string"
}
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
}
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DispensationHistoryResponseForAllSubjectV1"
},
"examples":{
"Unblinded Dispensation History For All Subjects Response":{
"description":"Unblinded Dispensation History For All Subjects Response",
"value":[
{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":10001,
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"inventoryStatusId":4,
"inventoryStatus":"Dispensed",
"dispensationDate":"2026-02-24T00:00:00Z",
"barcode":"61234",
"dispensationConfirmed":true,
"dose":1,
"measurement":"mg",
"frequency":"Once daily",
"returnedUnits":0,
"missingUnits":0,
"conserved":false,
"kitNumberUTF":"KIT-000123"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History For All Subjects Not Found Response":{
"description":"Unblinded Dispensation History For All Subjects Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No unblinded dispensation history was found.",
"details":{
"field":"subjectId",
"reason":"No matching subject dispensation history exists."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History For All Subjects Server Error Response":{
"description":"Unblinded Dispensation History For All Subjects Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded dispensation history.",
"details":{
"operation":"getUnblindedAllDispHistory",
"reason":"The unblinded dispensation history lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-unblinded-disp-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-unblinded-disp-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/unblinded-disp-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded dispensation history"
],
"summary":"v1.0",
"description":"Retrieves history of unblinded dispensation for a subject within the study. Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedDispensationHistory",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UnblindedDispensationHistoryDTO"
},
"examples":{
"Unblinded Dispensation History By Subject Response":{
"description":"Unblinded Dispensation History By Subject Response",
"value":{
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Bottle kit",
"packageTypeId":2,
"packageType":"BOTTLE",
"dispensationDetails":[
{
"kitNumber":10001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:45:00Z"
}
]
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Not Found Response":{
"description":"Unblinded Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Unblinded dispensation history was not found for the subject.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have unblinded dispensation history."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Bad Request Response":{
"description":"Unblinded Dispensation History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The unblinded dispensation history request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Server Error Response":{
"description":"Unblinded Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded dispensation history.",
"details":{
"operation":"getUnblindedDispensationHistory",
"reason":"The unblinded dispensation history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-unblinded-disp-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-srcsubjectid-unblinded-disp-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/unblinded-rand-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded randomization history"
],
"summary":"v1.0",
"description":"Retrieves history of unblinded randomizations for a subject within the study. Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedRandHistory",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UnblindedRandomizationHistoryDTO"
},
"examples":{
"Unblinded Randomization History Response":{
"description":"Unblinded Randomization History Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4,
"description":"TA",
"externalTreatmentId":"TRT-A",
"visitId":"B1B8327AFAA6412287106192AB5984EF"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History Not Found Response":{
"description":"Unblinded Randomization History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Unblinded randomization history was not found for the subject.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have unblinded randomization history."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History Server Error Response":{
"description":"Unblinded Randomization History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded randomization history.",
"details":{
"operation":"getUnblindedRandHistory",
"reason":"The unblinded randomization history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-unblinded-rand-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-srcsubjectid-unblinded-rand-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/unblinded-rand-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded randomization history for all subjects"
],
"summary":"v1.0",
"description":"Retrieves unblinded randomization history for all subjects within the study. Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedRandHistoryForAllSubjects",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UnblindedRandomizationHistoryDTO"
},
"examples":{
"Unblinded Randomization History For All Subjects Response":{
"description":"Unblinded Randomization History For All Subjects Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4,
"description":"TA",
"externalTreatmentId":"TRT-A",
"visitId":"B1B8327AFAA6412287106192AB5984EF"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History For All Subjects Not Found Response":{
"description":"Unblinded Randomization History For All Subjects Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No unblinded randomization history was found.",
"details":{
"field":"subjectId",
"reason":"No matching subject randomization history exists."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History For All Subjects Server Error Response":{
"description":"Unblinded Randomization History For All Subjects Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded randomization history.",
"details":{
"operation":"getUnblindedRandHistoryForAllSubjects",
"reason":"The unblinded randomization history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-unblinded-rand-history-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-unblinded-rand-history-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit by its visit ID. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"1001",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"mg",
"frequency":"QD",
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"quantity":1,
"lotId":"A1B8327AFAA6412287106192AB5984EF",
"lotNumber":"LOT20240605A"
}
],
"visitTimestamp":"2026-02-21T06:45:00Z",
"treatmentTitle":"TA",
"needsToVisitPharmacist":false,
"countOfKitTypesOnDoseHold":1,
"pendingKitQuantity":0,
"forcedRandomized":false
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Not Found Response":{
"description":"Get Visit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"The visit was not found for the subject.",
"details":{
"field":"visitId",
"reason":"The subject does not have the supplied visit."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Bad Request Response":{
"description":"Get Visit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The visit request is invalid.",
"details":{
"field":"externalSubjectId",
"reason":"The subject identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Server Error Response":{
"description":"Get Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving the visit.",
"details":{
"operation":"getVisit",
"reason":"The visit lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Randomize a subject and/or dispense kits during a randomization or dispensation visit. Rights: OrsVisitManagementPost.",
"operationId":"visit",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequest"
},
"examples":{
"Subject Visit Request":{
"description":"Subject Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2018-11-23 08:43:01",
"parameters":[
{
"formId":"B1B8327AFAA6412287106192AB5984EF",
"itemId":"C36A3197FDEE433FB5547EE83DE99E4B",
"value":"A"
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Subject Visit Response":{
"description":"Subject Visit Response",
"value":{
"randomNumber":"1001",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"mg",
"frequency":"QD",
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"quantity":1,
"lotId":"A1B8327AFAA6412287106192AB5984EF",
"lotNumber":"LOT20240605A",
"dosingInstruction":"Take one capsule daily"
}
],
"visitTimestamp":"2026-02-21T06:45:00Z",
"treatmentTitle":"TA",
"needsToVisitPharmacist":false,
"countOfKitTypesOnDoseHold":1,
"pendingKitQuantity":0,
"forcedRandomized":false
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Visit Server Error Response":{
"description":"Subject Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while processing the subject visit.",
"details":{
"operation":"visit",
"reason":"The visit could not be completed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/visits":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get list of visits"
],
"summary":"v1.0",
"description":"Retrieves a list of visits.
Rights: SupplySettingRightsGet.",
"operationId":"getVisits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Visit"
}
},
"examples":{
"Visits Response":{
"description":"Visits Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"externalVisitId":"Week 1",
"visitNumber":1,
"nextVisitDays":7,
"windowBeforeDays":2,
"windowAfterDays":2,
"isRepeating":false,
"isScheduled":true,
"isDispensation":true,
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"isRequiredValue":true
}
]
}
}
}
}
},
"404":{
"description":"For invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visits Not Found Response":{
"description":"Visits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Visits were not found for the study.",
"details":{
"field":"studyId",
"reason":"The supplied study does not contain visit data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visits Server Error Response":{
"description":"Visits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving visits.",
"details":{
"operation":"getVisits",
"reason":"The visit lookup could not be completed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-visits-get",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-visits-get"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/visits/migrateDispensation":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Migrate dispensation"
],
"summary":"v1.0",
"description":"Migrates dispensation records",
"operationId":"migrationDispensation",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/MigrationRequestV2"
},
"examples":{
"Migrate Dispensation Request":{
"description":"Migrate Dispensation Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"studyVersion":"1.0.0.5",
"kits":[
{
"sequenceNumber":10001,
"statusId":4,
"locationId":"B1B8327AFAA6412287106192AB5984EF"
}
],
"randomNumber":1001,
"randomizationListId":"D313327EF13845169A8ADADDA435431E",
"visitTimestamp":"2026-02-21 06:45:00"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Migrate Dispensation Response":{
"description":"Migrate Dispensation Response",
"value":{
"randomNumber":"1001",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"quantity":1,
"inventoryId":"D313327EF13845169A8ADADDA435431E"
}
],
"visitTimestamp":"2026-02-21T06:45:00Z",
"treatmentTitle":"TA"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Migrate Dispensation Server Error Response":{
"description":"Migrate Dispensation Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while migrating dispensation data.",
"details":{
"operation":"migrationDispensation",
"reason":"The migration request could not be completed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-visits-migrateDispensation-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-visits-migratedispensation-post"
}
},
"/ec-ors-svc/rest/v1.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/replacekits":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Replace a subject's kits"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Replaces a subject's kits in the system. Rights: OrsVisitManagementPost.",
"operationId":"replaceSubjectKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Subject replace kits parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsRequest"
},
"examples":{
"Replace Subject Kits Request":{
"description":"Replace Subject Kits Request",
"value":{
"kits":[
10001,
10002
],
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Damaged kits reported by the subject"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsResponse"
},
"examples":{
"Replace Subject Kits Response":{
"description":"Replace Subject Kits Response",
"value":{
"replacedKits":[
{
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"quantity":1
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found. Or site ID not found in site service",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Not Found Response":{
"description":"Replace Subject Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"The subject kits to replace were not found.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have matching kits for replacement."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or this operation is not allowed during the current subject statusOr invalid kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Bad Request Response":{
"description":"Replace Subject Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The subject kit replacement request is invalid.",
"details":{
"field":"kits",
"reason":"At least one replacement kit must be supplied."
}
}
}
}
}
}
}
},
"500":{
"description":"Subject is randomized in error. Or not enough inventory",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Server Error Response":{
"description":"Replace Subject Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while replacing subject kits.",
"details":{
"operation":"replaceSubjectKits",
"reason":"The replacement could not be completed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v1.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-replacekits-post",
"x-filename-id":"ec-ors-svc-rest-v1.0-studies-studyid-mode-subjects-srcsubjectid-replacekits-post"
}
},
"/ec-ors-svc/rest/v10.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"v10.0",
"description":"Retrieves an order's details by shipment ID. In this version, compoundingKits is added in the order. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrdersInventoryDTOV10"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"compoundingKits":true,
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"materialId":"B1B8327AFAA6412287106192AB5984EF",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT",
"materialId":"B1B8327AFAA6412287106192AB5984EF"
}
],
"nsInventory":[
{
"nsInventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"quantity":5,
"lotNumber":"lot1",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"transactionId":"D313327EF13845169A8ADADDA435431E"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"message":"Order not found for shipmentId 89EE76326E984B548D594D592E5C7FC2."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v10.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v10.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v10.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"v10.0",
"description":"Retrieves details of the orders. In this version, compoundingKits is added in the orders. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includePooledShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude pooled shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponseV10"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"compoundingKits":true,
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"materialId":"B1B8327AFAA6412287106192AB5984EF",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT",
"materialId":"B1B8327AFAA6412287106192AB5984EF"
}
],
"nsInventory":[
{
"nsInventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"quantity":5,
"lotNumber":"lot1",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"transactionId":"D313327EF13845169A8ADADDA435431E"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v10.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v10.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v10.0/studies/{studyId}/{mode}/supply/settings":{
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"v10.0",
"description":"Updates a study's supply settings by study ID. This version includes new field selectShippingAddress.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTO"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true,
"dispenseByLowestKitNumber":true,
"allowDoseHold":true,
"quarantineWithoutTempMonitor":false,
"randomizeWhenKitsAvailable":false,
"allKitsSelectedForRandomization":false,
"kitsSelectedForRandomization":[
"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"6A2D911A4E5E4D61B29A1CC73E5402AB"
],
"sendNotificationOnce":false,
"tempExcursionStartingNumber":"12,13",
"selectShippingAddress":false
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v10.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v10.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v10.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"v10.0",
"description":"Retrieves dispensation history for a study, by subject and visit ID. This version includes additional fields for non-serialized kits and for quantity, subjectVisitNsInventoryId, lotId and lotNumber.
Rights: OrsSubjectVisitGet.",
"operationId":"getDispensationHistory_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"asofdate",
"in":"query",
"description":"Get data as of the given date",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-03-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponseV10"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":1001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:30:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"packageTypeId":2,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"lastModifiedDate":"2026-02-22T09:45:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"deviceType":"MobileApp",
"deviceConnection":"DevicetoCloud",
"mHealthDeviceId":"D313327EF13845169A8ADADDA435431E",
"conserved":false,
"allowReplacement":true,
"instanceNumber":1,
"barcode":"1236",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"quantity":1,
"kitNumberUTF":"000AB123",
"inventoryStatusName":"Dispensed",
"userId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"titration":"maintain",
"subjectVisitNsInventoryId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"mf1",
"originalLotNumber":"mf1"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v10.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v10.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v10.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v10.0",
"description":"Deprecated: Retrieves visit by visit ID. This is a new version of the API for adding additional attribute hasUnblindedPharmacistKits for unblinded users. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV9"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"groupingNumber":1,
"kitNumberUTF":"A-1",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"LOT20240605A",
"dosingInstruction":"Take one capsule daily"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":false,
"countOfKitTypesOnDoseHold":0,
"pendingKitQuantity":1,
"forcedRandomized":false
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v10.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v10.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v10.0",
"description":"Deprecated: Randomize a subject and/or dispense kits during a randomization or dispensation visit. This version of the API includes additional attributes for barcodes and dispensationConfirmed. Rights: OrsVisitManagementPost.",
"operationId":"visit_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV7"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:30:00"
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV9"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"groupingNumber":1,
"kitNumberUTF":"A-1",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"LOT20240605A",
"dosingInstruction":"Take one capsule daily"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":false,
"countOfKitTypesOnDoseHold":0,
"pendingKitQuantity":1,
"forcedRandomized":false
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v10.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v10.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v11.0/studies/{studyId}/{mode}/supply/settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Get supply settings"
],
"summary":"v11.0",
"description":"Retrieves supply settings. This version includes new fields dispenseFromSameLot and shipFromSameLot.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsGet.",
"operationId":"getSupplySettings_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTO"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":1,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"kitReconcillationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v11.0-studies-{studyId}-{mode}-supply-settings-get",
"x-filename-id":"ec-ors-svc-rest-v11.0-studies-studyid-mode-supply-settings-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"v11.0",
"description":"Updates a study's supply settings by study ID. This version includes new fields dispenseFromSameLot and shipFromSameLot.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"SupplySettingTO parameter.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTO"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":1,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"kitReconcillationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v11.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v11.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v11.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"v11.0",
"description":"Retrieves dispensation history for a study, by subject and visit ID. This version includes additional fields for non-serialized kits and for quantity, subjectVisitNsInventoryId, lotId and lotNumber.
Rights: OrsSubjectVisitGet.",
"operationId":"getDispensationHistory_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"asofdate",
"in":"query",
"description":"Get data as of the given date",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-03-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponseV10"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":"KIT-0001",
"dispensedDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v11.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v11.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v11.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v11.0",
"description":"Deprecated: Retrieves visit by visit ID. This is a new version of the API for adding additional attribute groupingNumber for kits. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV10"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v11.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v11.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v11.0",
"description":"Deprecated: Schedules a new visit in the study. This is a new version of the API for adding additional attribute groupingNumber for kits. Rights: OrsVisitManagementPost.",
"operationId":"visit_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV7"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV10"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v11.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v11.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v12.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v12.0",
"description":"Deprecated: Retrieves visit by visit ID. This is a new version of the API for adding additional attribute countOfKitTypesOnDoseHold. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV11"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v12.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v12.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v12.0",
"description":"Deprecated: Schedules a new visit in the study. This is a new version of the API for adding kitTypesForDoseHold,kitTypesForResumeDispensation in request. Rights: OrsVisitManagementPost.",
"operationId":"visit_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV8"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV11"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v12.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v12.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v13.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v13.0",
"description":"Deprecated: Schedules a new visit in the study. This version of the API enables placing an unblinded pharmacist kit on hold or resuming its dispensation. Rights: OrsVisitManagementPost.",
"operationId":"getVisit_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV12"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v13.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v13.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v13.0",
"description":"Deprecated: Schedules a new visit in the study. This version of the API enables placing an unblinded pharmacist kit on hold or resuming its dispensation. Rights: OrsVisitManagementPost.",
"operationId":"visit_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV9"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV11"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v13.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v13.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v14.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v14.0",
"description":"Deprecated: This is a new version of the API which sends the partial dispensation details in the new field pendingKitQuantity in response.",
"operationId":"getVisit_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v14.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v14.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v14.0",
"description":"Deprecated: Schedules a new visit in the study. This is a new version of the API which enables to show kitNumberUTF8 field in response.",
"operationId":"visit_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV9"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v14.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v14.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v15.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v15.0",
"description":"Deprecated: This is a new version of the API which sends the locallySourced and quantity field in response.",
"operationId":"getVisit_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v15.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v15.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v15.0",
"description":"Deprecated: Randomize a subject and/or dispense kits during a randomization or dispensation visit. This version of the API enables to send request with resumePartialDispensation to resume partial dispensation and pendingKitQuantity field in response.",
"operationId":"visit_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequest"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v15.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v15.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v16.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"v16.0",
"description":"This is a new version of the API which sends the lotId, lotNumber and quantity field in response for non serialized kits.",
"operationId":"getVisit_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"visitTimestamp":"2026-03-23T10:30:00Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":true,
"countOfKitTypesOnDoseHold":1,
"pendingKitQuantity":1,
"forcedRandomized":false,
"kits":[
{
"id":2,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"deviceType":"ActivityWatch",
"deviceConnection":"DevicetoCloud",
"trialSupplyType":"BOTTLE",
"quantity":1,
"lotId":"D313327EF13845169A8ADADDA435431E",
"lotNumber":"LOT20240605A",
"barcode":"1000",
"dispensationConfirmed":true
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v16.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v16.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v16.0",
"description":"Deprecated: Randomize a subject and/or dispense kits during a randomization or dispensation visit. This version of the API returns the locallySourced and quantity fields in the response to support local sourcing.",
"operationId":"visit_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequest"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"kitId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":"KIT-0001"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v16.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v16.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v17.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"v17.0",
"description":"This is a new version of the API which sends the dosing Instructions field in response for advanced dispensation kits.",
"operationId":"getVisit_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"visitTimestamp":"2026-03-23T10:30:00Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":true,
"countOfKitTypesOnDoseHold":1,
"pendingKitQuantity":1,
"forcedRandomized":false,
"kits":[
{
"id":2,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"deviceType":"ActivityWatch",
"deviceConnection":"DevicetoCloud",
"trialSupplyType":"BOTTLE",
"quantity":1,
"lotId":"D313327EF13845169A8ADADDA435431E",
"lotNumber":"LOT20240605A",
"barcode":"1000",
"dispensationConfirmed":true
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"errorData":"Not found"
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"errorData":"Invalid request"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"errorData":"Server error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v17.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v17.0-studies-studyid-mode-visits-subjectvisit-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/lots/blinded-lots":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get blinded lots"
],
"summary":"v2.0",
"description":"Retrieves list of blinded lots by study ID. Rights: LotManagementGet, ORSBlindedDepotGet.",
"operationId":"getAllBlindedLots_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":50
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotResponseV2"
},
"examples":{
"Get Blinded Lots Response":{
"description":"Get Blinded Lots Response",
"value":{
"blindedLots":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
]
}
]
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lots Forbidden Response":{
"description":"Get Blinded Lots Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"getAllBlindedLots",
"reason":"The caller does not have permission to view blinded lots."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lots Server Error Response":{
"description":"Get Blinded Lots Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while retrieving blinded lots.",
"details":{
"operation":"getAllBlindedLots",
"reason":"The blinded lot lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-blinded-lots-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-blinded-lots-get"
},
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create blinded lot"
],
"summary":"v2.0",
"description":"Creates a blinded lot by study ID. Rights: LotManagementPost.",
"operationId":"createBlindedLot_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotRequest"
},
"examples":{
"Create Blinded Lot Request":{
"description":"Create Blinded Lot Request",
"value":{
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
]
}
}
}
}
},
"required":true
},
"responses":{
"201":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotId"
},
"examples":{
"Create Blinded Lot Response":{
"description":"Create Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"400":{
"description":"Blinded lot number or lot short name already exists. OR Expiration date is not valid. OR Invalid lot. OR Lot belongs to a blinded lot.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinded Lot Bad Request Response":{
"description":"Create Blinded Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot request is invalid.",
"details":{
"field":"manufacturingLotIds",
"reason":"At least one valid manufacturing lot identifier must be supplied."
}
}
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinded Lot Forbidden Response":{
"description":"Create Blinded Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"createBlindedLot",
"reason":"The caller does not have permission to create blinded lots."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Blinded Lot Server Error Response":{
"description":"Create Blinded Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while creating the blinded lot.",
"details":{
"operation":"createBlindedLot",
"reason":"The blinded lot could not be created."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-blinded-lots-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-blinded-lots-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/lots/blinded-lots/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get blinded lot by ID"
],
"summary":"v2.0",
"description":"Retrieves blinded lot by a blinded lot's ID. Rights: LotManagementGet, ORSBlindedDepotGet.",
"operationId":"getBlindedLot_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of blinded lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsV3"
},
"examples":{
"Get Blinded Lot Response":{
"description":"Get Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
]
}
}
}
}
}
},
"404":{
"description":"Blinded lot not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lot Not Found Response":{
"description":"Get Blinded Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinded lot was not found.",
"details":{
"field":"id",
"reason":"The supplied blinded lot identifier does not exist."
}
}
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lot Forbidden Response":{
"description":"Get Blinded Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"getBlindedLot",
"reason":"The caller does not have permission to view the blinded lot."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Blinded Lot Server Error Response":{
"description":"Get Blinded Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while retrieving the blinded lot.",
"details":{
"operation":"getBlindedLot",
"reason":"The blinded lot lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-blinded-lots-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-blinded-lots-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update blinded lot"
],
"summary":"v2.0",
"description":"Updates a blinded lot by study ID and blinded lot ID. Rights: LotManagementPost.",
"operationId":"updateBlindedLot_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of blinded lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotRequest"
},
"examples":{
"Update Blinded Lot Request":{
"description":"Update Blinded Lot Request",
"value":{
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotId"
},
"examples":{
"Update Blinded Lot Response":{
"description":"Update Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"400":{
"description":"Blinded lot number or lot short name already exists. OR Expiration date is not valid. OR Invalid lot. OR Lot belongs to a blinded lot.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinded Lot Bad Request Response":{
"description":"Update Blinded Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot update request is invalid.",
"details":{
"field":"shortName",
"reason":"The blinded lot short name must be unique."
}
}
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinded Lot Forbidden Response":{
"description":"Update Blinded Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-403",
"errorMessage":"Access denied.",
"details":{
"operation":"updateBlindedLot",
"reason":"The caller does not have permission to update blinded lots."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Blinded Lot Server Error Response":{
"description":"Update Blinded Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-500",
"errorMessage":"Unexpected error while updating the blinded lot.",
"details":{
"operation":"updateBlindedLot",
"reason":"The blinded lot could not be updated."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-blinded-lots-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-blinded-lots-id-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/blindinggroups/{blindingGroupId}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Get blinding group by ID"
],
"summary":"v2.0",
"description":"Retrieves blinding group in a study by blinding group ID.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"getBlindingGroup_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"blindingGroupId",
"in":"path",
"description":"ID of blinding group.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindingGroupResponse.BlindingGroup"
},
"examples":{
"Get Blinding Group Response":{
"description":"Get Blinding Group Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"title":"Blinding Group Lotion",
"description":"Some description.",
"kitTypes":[
{
"id":"BOTTLE-A",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5,
"packageType":"BOTTLE",
"deviceType":"GlucoseMonitor",
"deviceConnection":"NoConnection",
"srcId":"D313327EF13845169A8ADADDA435431E"
}
],
"defaultBlindingKit":"392DA9F053E94B9B9339AC7D0FA0D1DB"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
},
"404":{
"description":"Invalid study. OR Blinding Group not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Blinding group not found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-blindinggroups-{blindingGroupId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-blindinggroups-blindinggroupid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/blindinggroups":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Get all blinding groups"
],
"summary":"v2.0",
"description":"Retrieves all blinding groups in a study. Required sponsor roles are: clinical supply manager and site manager.Please refer to getPackageTypes API for packageTypeId. A study cannot have both DEFAULT and RANDOM blinding group strategies. Based upon the single kit setting (RANDOM, DEFAULT, ALL) at a study level, the UI should restrict drop down values (SEND_KIT_TYPE/RANDOM_KIT). RANDOM_KIT should be hidden if the single kit setting at a study level is DEFAULT. Similarly, SEND_KIT_TYPE should be hidden if the single kit setting is RANDOMor ALL. getStudy API has been modified to return more parameters like singleKitSettingId and useBlindingGroups.
Rights: SupplySettingRightsPost.",
"operationId":"getBlindingGroups_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindingGroupResponse"
},
"examples":{
"Get Blinding Groups Response":{
"description":"Get Blinding Groups Response",
"value":{
"blindingGroups":[
{
"blindingGroupId":"B1B8327AFAA6412287106192AB5984EF",
"name":"BlindingGroup-01"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
},
"404":{
"description":"Invalid study.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Study not found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-blindinggroups-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-blindinggroups-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kittypes/noblindinggroup":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Blinding Group/Get kit types which do not belong to any blinding group"
],
"summary":"v2.0",
"description":"Retrieves kit types which do not belong to any blinding group.
Rights: SupplySettingRightsGet.
Required sponsor roles are: clinical supply manager and site manager.",
"operationId":"getKitTypesNotInBlindingGroup_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitType"
}
},
"examples":{
"Get Kit Types Without Blinding Group Response":{
"description":"Get Kit Types Without Blinding Group Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non-Dosing"
}
]
}
}
}
}
},
"404":{
"description":"Study not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Study not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kittypes-noblindinggroup-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kittypes-noblindinggroup-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/settings/cohortlimits":{
"get":{
"tags":[
"Randomization and Supplies/Cohort APIs/Get cohort limits by study and mode"
],
"summary":"v2.0",
"description":"Retrieves cohort limits by study and mode. Rights: SubjectSettingRightsGet.",
"operationId":"getCohortLimits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortLimitV2"
}
},
"examples":{
"Get Cohort Limits Response":{
"description":"Get Cohort Limits Response",
"value":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"stratumId":"C36A3197FDEE433FB5547EE83DE99E4B",
"randomizationLimit":100,
"notificationLimit":80,
"enabled":true
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-settings-cohortlimits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-settings-cohortlimits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Cohort APIs/Save cohort limits by study and mode"
],
"summary":"v2.0",
"description":"Saves cohort limits by study and mode. Rights: SubjectSettingRightsPost.",
"operationId":"setCohortLimits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"fromMode",
"in":"query",
"description":"From mode.",
"schema":{
"type":"string"
},
"example":"test"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/CohortLimitList"
},
"examples":{
"Set Cohort Limits Request":{
"description":"Set Cohort Limits Request",
"value":{
"cohortLimits":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"stratumId":"C36A3197FDEE433FB5547EE83DE99E4B",
"randomizationLimit":100,
"notificationLimit":80,
"enabled":true
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortLimitV2"
}
},
"examples":{
"Set Cohort Limits Response":{
"description":"Set Cohort Limits Response",
"value":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"stratumId":"C36A3197FDEE433FB5547EE83DE99E4B",
"randomizationLimit":100,
"notificationLimit":80,
"enabled":true
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-settings-cohortlimits-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-settings-cohortlimits-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/recon/shipments":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create shipment for kits marked for destruction from a given site to depot"
],
"summary":"v2.0",
"description":"Rights needed: DDFShipmentPost; versioned to return the form ID in the response.",
"operationId":"createShipment_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReconShipmentRequest"
},
"examples":{
"Create Recon Shipment Request":{
"description":"Create Recon Shipment Request",
"value":{
"kits":[
"E39FF55A445543A38D513325664F0B2D"
],
"kitsFilter":{
"kitRange":"KIT_NUMBER:10:100",
"searchString":"Some search string",
"inventoryStatusIds":[
5
],
"subjectId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ResupplyResponseV2"
}
},
"examples":{
"Create Recon Shipment Response":{
"description":"Create Recon Shipment Response",
"value":[
{
"formId":"B1B8327AFAA6412287106192AB5984EF"
}
]
}
}
}
}
},
"404":{
"description":"Site ID not found in site service.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"ORS-404",
"errorMessage":"Resource not found",
"details":{
"field":"siteId",
"issue":"not found"
}
}
}
}
}
}
},
"400":{
"description":"'Kit reconciliation required was not set.', 'You cannot update the status of this kit because the kit was sent to a depot', 'You cannot update the status of this kit because it is at a site that you do not have access to. Work with your CRA or a clinical supply manager to update the kit.', 'Reconciliation shipment is not allowed as site has drug destruction capability.', 'Reconciliation shipment cannot be created as none of the depots has drug destruction capability.', 'Update kits cannot have both the kit identifiers list and the kits filter set.', 'Update kits must have either the kit identifiers list or the kits filter set.', 'Invalid inventory status transition.', 'Invalid kit at site.', 'Invalid kit range filter.', 'subjectId is required.', 'Invalid subject.', 'Update kits no rows were found to update.', 'Update kits retrieved size exceeds maximum rows for update limit of.', 'Update kits retrieve error, the following kit identifiers were not found.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"ORS-076",
"errorMessage":"Invalid kit range filter.",
"details":{
"field":"kitsFilter.kitRange",
"issue":"Use KIT_NUMBER:start:end with start less than or equal to end."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"ORS-500",
"errorMessage":"Unexpected error",
"details":{
"issue":"Unhandled exception"
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-recon-shipments-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-recon-shipments-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/dbheaders/uploadkits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get inventory database headers"
],
"summary":"v2.0",
"description":"Retrieves inventory headers containing barcodes from the database.",
"operationId":"getInventoryDBHeaders_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/UploadDBHeaderResponse"
},
"examples":{
"Get Inventory DB Headers Response":{
"description":"Get Inventory DB Headers Response",
"value":{
"dbHeaders":[
"Kit Type",
"Kit Number"
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory DB Headers Server Error Response":{
"description":"Get Inventory DB Headers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving inventory database headers.",
"details":{
"operation":"getInventoryDBHeaders",
"reason":"The inventory database headers could not be loaded."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-dbheaders-uploadkits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-dbheaders-uploadkits-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/dbheaders/uploadrndlist":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get randomization list database headers"
],
"summary":"v2.0",
"description":"Retrieves randomization list headers from the database.",
"operationId":"getRndListDBHeaders_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/UploadDBHeaderResponse"
},
"examples":{
"Get Randomization List DB Headers Response":{
"description":"Get Randomization List DB Headers Response",
"value":{
"dbHeaders":[
"Randomization Number",
"Treatment",
"Block",
"Stratum",
"Cohort",
"Probability Factor"
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List DB Headers Server Error Response":{
"description":"Get Randomization List DB Headers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"RND-500",
"errorMessage":"Unexpected error while retrieving randomization list database headers.",
"details":{
"operation":"getRndListDBHeaders",
"reason":"The randomization list database headers could not be loaded."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-dbheaders-uploadrndlist-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-dbheaders-uploadrndlist-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/doseholdsettings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Get all dose hold settings details"
],
"summary":"v2.0",
"description":"Retrieves all dose hold settings details including last visit. Rights required:SupplySettingRightsGet.",
"operationId":"getDoseHolds_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DoseHoldSettingsResponseTOV2"
}
},
"examples":{
"Get Dose Hold Settings Response":{
"description":"Get Dose Hold Settings Response",
"value":[
{
"doseHoldID":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"startingVisitSrcId":"D313327EF13845169A8ADADDA435431E",
"instanceNumber":1,
"enabled":true,
"frequencyUnlimited":false,
"maxDoseHolds":3,
"frequencyLimitInSequence":2,
"frequencyLimitInDays":30,
"endingVisitSrcId":"D313327EF13845169A8ADADDA435431F",
"endingVisitInstanceNumber":3
}
]
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid request."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-doseholdsettings-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-doseholdsettings-get"
},
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Create dose hold settings for the given dose hold"
],
"summary":"v2.0",
"description":"Adds dose hold setting for a given dose hold. Rights required:SupplySettingRightsPost.",
"operationId":"createDoseHoldSettings_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldSettingsRequestV2"
},
"examples":{
"Create Dose Hold Settings Request":{
"description":"Create Dose Hold Settings Request",
"value":{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"startingVisitSrcId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"instanceNumber":1,
"enabled":true,
"frequencyUnlimited":false,
"maxDoseHolds":3,
"frequencyLimitInSequence":2,
"frequencyLimitInDays":30
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldResponse"
},
"examples":{
"Create Dose Hold Settings Response":{
"description":"Create Dose Hold Settings Response",
"value":{
"doseHoldId":"F0E1D2C3B4A5968778695A4B3C2D1E0F"
}
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold Setting Details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid dose hold settings request."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-doseholdsettings-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-doseholdsettings-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/doseholdsettings/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Get dose hold setting details of given dose hold by ID"
],
"summary":"v2.0",
"description":"Retrieves dose hold setting details of given dose hold identified by ID including last visit. Rights required:SupplySettingRightsGet.",
"operationId":"getDoseHoldById_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"Dose Hold ID.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldSettingsResponseTOV2"
},
"examples":{
"Get Dose Hold By Id Response":{
"description":"Get Dose Hold By Id Response",
"value":{
"doseHoldID":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"startingVisitSrcId":"D313327EF13845169A8ADADDA435431E",
"instanceNumber":1,
"enabled":true,
"frequencyUnlimited":false,
"maxDoseHolds":3,
"frequencyLimitInSequence":2,
"frequencyLimitInDays":30,
"endingVisitSrcId":"D313327EF13845169A8ADADDA435431F",
"endingVisitInstanceNumber":3
}
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid dose hold id."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-doseholdsettings-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-doseholdsettings-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Dose Hold Settings/Update dose hold settings of a given dose hold by ID"
],
"summary":"v2.0",
"description":"Updates dose hold settings of a given dose hold identified by ID. Rights required: SupplySettingRightsPost.",
"operationId":"updateDoseHoldSettings_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"Dose Hold ID.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldSettingsRequestV2"
},
"examples":{
"Update Dose Hold Settings Request":{
"description":"Update Dose Hold Settings Request",
"value":{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"startingVisitSrcId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"instanceNumber":1,
"enabled":true,
"frequencyUnlimited":false,
"maxDoseHolds":3,
"frequencyLimitInSequence":2,
"frequencyLimitInDays":30
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldResponse"
},
"examples":{
"Update Dose Hold Settings Response":{
"description":"Update Dose Hold Settings Response",
"value":{
"doseHoldId":"F0E1D2C3B4A5968778695A4B3C2D1E0F"
}
}
}
}
}
},
"400":{
"description":"Invalid Dose Hold Setting Details",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid dose hold settings request."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-doseholdsettings-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-doseholdsettings-id-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/events/codebreak/{eventId}":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get details about a Code Break event"
],
"summary":"v2.0",
"description":"Retrieves details about a Code Break event in the study. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeBreakEvent_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"eventId",
"in":"path",
"description":"ID of event.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Get Code Break Event Response":{
"description":"Get Code Break Event Response",
"value":"codebreak event payload"
}
}
}
}
},
"404":{
"description":"Study identifier does not match any study identifiers in Clinical One. OR Event not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Event not found."
}
}
}
}
}
},
"400":{
"description":"Incorrect event type. Or No data found for the event.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid event id."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-events-codebreak-{eventId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-events-codebreak-eventid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/events/kitreplacement/{eventId}":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get details about a Kit Replacement event"
],
"summary":"v2.0",
"description":"Retrieves details on kit replacement events for a subject with non-serialized kits. Rights: OrsSubjectVisitGet.",
"operationId":"getKitReplacementEvent_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"eventId",
"in":"path",
"description":"ID of event.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Get Kit Replacement Event Response":{
"description":"Get Kit Replacement Event Response",
"value":"kit replacement event payload"
}
}
}
}
},
"404":{
"description":"Study identifier does not match any study identifiers in Clinical One. OR Event not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Event not found."
}
}
}
}
}
},
"400":{
"description":"Incorrect event type OR No data found for the event",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid event id."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-events-kitreplacement-{eventId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-events-kitreplacement-eventid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/depots/{depotId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kits from depot inventory by depot ID"
],
"summary":"v2.0",
"description":"Retrieves a list of serialized and/or non-serialized kits on a depot inventory, based on the filters passed in the request.
Rights: ORSBlindedDepotGet.",
"operationId":"getDepotKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"depotId",
"in":"path",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical depot",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"searchByKitNumber",
"in":"query",
"description":"Kit Number search string.",
"schema":{
"type":"string"
},
"example":10001
},
{
"name":"searchBySeqNumber",
"in":"query",
"description":"Sequence number search string.",
"schema":{
"type":"number"
},
"example":10
},
{
"name":"sequenceNumberMin",
"in":"query",
"description":"Minimum sequence number for search",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"sequenceNumberMax",
"in":"query",
"description":"Maximum sequence number for search",
"schema":{
"type":"number"
},
"example":9999
},
{
"name":"kitNumberMin",
"in":"query",
"description":"Minimum kit number for search",
"schema":{
"type":"number"
},
"example":10000
},
{
"name":"kitNumberMax",
"in":"query",
"description":"Maximum kit number for search",
"schema":{
"type":"number"
},
"example":20000
},
{
"name":"blindedLotId",
"in":"query",
"description":"Blinded lot ID for search",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentNumber",
"in":"query",
"description":"Shipment number for search",
"schema":{
"type":"string"
},
"example":"SHP-10001"
},
{
"name":"quarantineId",
"in":"query",
"description":"Quarantine ID for search",
"schema":{
"type":"string"
},
"example":"QTN-0001"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32",
"default":0
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32",
"default":100
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":1
},
{
"name":"serialized",
"in":"query",
"description":"Is kit serialized or non-serialized",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DepotKitDetailsResponse"
},
"examples":{
"Get Depot Kits Response":{
"description":"Get Depot Kits Response",
"value":{
"distinctInventoryStatusIds":[
1
],
"blindedLotsExistsInStudy":true,
"kits":[
{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumberUTF":"10001",
"sequenceNumber":1,
"inventoryStatusId":1,
"inventoryStatus":"Available",
"unitsPerKit":30,
"kitDescription":"Bottle of tablets",
"distributionSetting":"BLINDED",
"barcode":"BAR-10001",
"blindedLotExpirationDate":"2026-12-31T00:00:00Z"
}
],
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving depot kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID OR study still in design phase OR invalid depot ID OR invalid subject ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The depot was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The depot kit filters are invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-depots-{depotId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-depots-depotid-inventory-kits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit attributes from depot inventory by depot ID"
],
"summary":"v2.0",
"description":"Updates kit attributes from depot inventory by depot ID, for both serialized and non serialized kits. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateDepotKits",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"depotId",
"in":"path",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical depot",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateDepotKitsRequestV2"
},
"examples":{
"Update Depot Kits Request":{
"description":"Update Depot Kits Request",
"value":{
"kitFilters":{
"searchByKitNumber":"10001",
"searchBySeqNumber":10,
"sequenceNumberMin":1,
"sequenceNumberMax":9999,
"kitNumberMin":10000,
"kitNumberMax":20000,
"blindedLotId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"SHP-10001",
"quarantineId":"QTN-0001",
"inventoryStatusIds":[
1
]
},
"kits":[
"B1B8327AFAA6412287106192AB5984EF"
],
"inventoryStatusId":1,
"reason":"Routine depot reconciliation"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateDepotKitsResponse"
},
"examples":{
"Update Depot Kits Response":{
"description":"Update Depot Kits Response",
"value":{
"updatedCount":1
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The depot or selected kits were not found."
}
}
}
}
}
}
},
"400":{
"description":"Specify at least one kit attribute OR Reason is required OR Specify at least one filter. OR Either kits or kitFilters is required OR Invalid kit status OR Invalid kit range filter OR Invalid lot OR Invalid label group in kit filters OR Invalid kit type OR Invalid location OR No kits to update OR Update kits retrieved size exceeds maximum rows for update limit OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The depot kit update request is invalid."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating depot kits."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-depots-{depotId}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-depots-depotid-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kits/{sourceId}/export":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Export kit details for the inventory"
],
"summary":"v2.0",
"description":"Exports kit details with barcodes for the inventory source as a CSV file. Rights: DesignerKitListGet.",
"operationId":"export_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"sourceId",
"in":"path",
"description":"Source ID of the inventory.",
"required":true,
"schema":{
"type":"string"
},
"example":"9ECA4FA65076451DA7D47D59367D15A5"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"*/*":{
"examples":{
"Export Inventory Kits Success (No Content)":{
"description":"Export is streamed as a file download; response has no body."
}
}
}
}
},
"404":{
"description":"No matching inventory source is available",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Export Inventory Kits Not Found Response":{
"description":"Export Inventory Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The inventory source was not found.",
"details":{
"field":"sourceId",
"reason":"The supplied inventory source identifier does not exist."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Export Inventory Kits Server Error Response":{
"description":"Export Inventory Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while exporting inventory kits.",
"details":{
"operation":"export_V2",
"reason":"The inventory export failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kits-{sourceId}-export-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kits-sourceid-export-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kits/generate":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Generate kits"
],
"summary":"v2.0",
"description":"Generates kits. Rights: DesignerKitListPost. This API contains additional attributes added in the request body for barcode implementation.",
"operationId":"generateKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Kit attribute parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateKitsRequest"
},
"examples":{
"Generate Kits Request":{
"description":"Generate Kits Request",
"value":{
"title":"Comparative Cream - Batch B",
"description":"Initial kit generation for the study",
"kitTypes":[
{
"id":"b1b8327a-faa6-4122-8710-6192ab5984ef",
"quantity":10
}
],
"kitNumberStart":1001,
"sequenceNumberStart":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateKitsResponse"
},
"examples":{
"Generate Kits Response":{
"description":"Generate Kits Response",
"value":{
"inventorySourceId":"b1b8327a-faa6-4122-8710-6192ab5984ef",
"noOfKitsGenerated":10
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version ",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"The Title has already been used OR Invalid kit type OR The maximum number of rows requested shall not exceed 500000 OR Some numbers in this list are used in another kit list. Adjust the first kit or sequence number so that the values don't overlap with existing numbers. OR 1 or more sequence numbers already exist OR 1 or more kit numbers already exist OR The CSV might contain duplicate kit number(s) or sequence number(s).",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kits-generate-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kits-generate-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventorystatuses/allowed/{fromInventoryStatusId}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get allowed inventory statuses"
],
"summary":"v2.0",
"description":"Retrieves allowed inventory statuses. Rights: OrsInventoryGet.",
"operationId":"getAllowedInventoryStatuses_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"fromInventoryStatusId",
"in":"path",
"description":"ID of the initial inventory status in status transition.",
"required":true,
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Allowed Inventory Statuses Response":{
"description":"Get Allowed Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":2,
"inventoryStatus":"Damaged"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Allowed Inventory Statuses Server Error Response":{
"description":"Get Allowed Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventorystatuses-allowed-{fromInventoryStatusId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventorystatuses-allowed-frominventorystatusid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventory/kits/{inventoryId}/dispensation":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get dispensation details by inventory ID"
],
"summary":"v2.0",
"description":"Retrieves dispensation details like subject source ID, visit source ID and instance number for a given inventory ID. Rights: OrsInventoryGet.",
"operationId":"getInventoryDispensation_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
},
"examples":{
"Get Inventory Dispensation Response":{
"description":"Get Inventory Dispensation Response",
"value":{
"inventoryStatusId":4,
"inventoryStatus":"Dispensed",
"reason":"Dispensed to subject",
"returnedUnits":0,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventory-kits-{inventoryId}-dispensation-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventory-kits-inventoryid-dispensation-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventorystatuses":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get inventory statuses"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves statuses from an inventory. Rights: OrsInventoryGet.",
"operationId":"getInventoryStatuses_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Inventory Statuses Response":{
"description":"Get Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory Statuses Server Error Response":{
"description":"Get Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventorystatuses-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventorystatuses-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventory/kitDetails":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit details by kit number"
],
"summary":"v2.0",
"description":"Retrieves kit details by kit number. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitByKitNumber_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitInfoResponse"
},
"examples":{
"Get Kit By Kit Number Response":{
"description":"Get Kit By Kit Number Response",
"value":{
"kitDetails":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"manufacturingLotId":"LOT-001",
"labelGroupId":"LABEL-001",
"inventoryStatus":"Available",
"blockNumber":"BLK-01",
"kitNumberUTF":"KIT-1001"
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid kit number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventory-kitDetails-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventory-kitdetails-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kits/{kitNumberUTF}/lastStatus":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get a kit's last status"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a kit's last status. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitLastStatus_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"kitNumberUTF",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-1001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusResponse"
},
"examples":{
"Get Kit Last Status Response":{
"description":"Get Kit Last Status Response",
"value":{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid Inventory Status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kits-{kitNumberUTF}-lastStatus-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kits-kitnumberutf-laststatus-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kitlists":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit list details"
],
"summary":"v2.0",
"description":"Retrieves generated/uploaded kit lists details in a study. Rights: OrsInventoryGet.",
"operationId":"getKitListsDetails_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitListDetailsTOV2"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kitlists-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kitlists-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventory/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary of serialized and non-serialized kits"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a kit's summary. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitSummary",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTypeSummaryResponse"
}
},
"examples":{
"Get Kit Summary Response":{
"description":"Get Kit Summary Response",
"value":[
{
"kitTypes":[
{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"description":"Example kit type.",
"packageTypeId":1,
"packageType":"Bottle",
"totalKitNumbers":100,
"kitsDispensed":5,
"kitsDamaged":1,
"kitsAvailable":94,
"kitsInTransit":0,
"kitsReturnedToSite":0,
"kitsPendingDestruction":0,
"kitsExpired":0
}
]
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Not Found Response":{
"description":"Get Kit Summary Not Found Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Bad Request Response":{
"description":"Get Kit Summary Bad Request Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Server Error Response":{
"description":"Get Kit Summary Server Error Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventory-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventory-kit-types-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventory/kits/audit":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Kit list details for each kit"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Kit list details of each kit. Rights: OrsInventoryGet.",
"operationId":"getKitsAudit_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"required":true,
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"required":true,
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
},
{
"name":"inventorySourceId",
"in":"query",
"schema":{
"type":"string"
}
},
{
"name":"transactionId",
"in":"query",
"schema":{
"type":"string"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditRequestV1"
},
"examples":{
"Kits Audit Request":{
"description":"Kits Audit Request",
"value":{
"kits":[
"b1b8327a-faa6-4122-8710-6192ab5984ef"
]
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditResponse"
}
}
}
},
"404":{
"description":"Invalid study ID OR Study not found OR Inventory Source ID not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid Kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventory-kits-audit-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventory-kits-audit-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventory/kit-types/{kitTypeId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary by kit type ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves kit summary by kit type ID. In this API, kitNumber added in request to filter kits by kitNumber, fields blockNumber and kitNumberUTF added to return block number and kit number in UTF-8. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitsByKitTypeId_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"kitTypeId",
"in":"path",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string"
},
"example":100
},
{
"name":"sortBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered. Default value is 'SEQUENCE_NUMBER'.",
"schema":{
"type":"string",
"default":"SEQUENCE_NUMBER"
},
"example":"SEQUENCE_NUMBER"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"schema":{
"type":"string"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDetailsResponse"
},
"examples":{
"Get Kits By Kit Type ID Response":{
"description":"Get Kits By Kit Type ID Response",
"value":{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"minSequenceNumber":1,
"maxSequenceNumber":10,
"minKitNumber":1001,
"maxKitNumber":1010,
"kits":[
{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"inventoryStatus":"Available"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version or Kit type not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filtersOR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventory-kit-types-{kitTypeId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventory-kit-types-kittypeid-kits-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventory/qualified-kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get list of filtered kits"
],
"summary":"v2.0",
"description":"Retrieves list of kits which had qualified recent updates based on criteria defined by Oracle Clinical One Integration Hub. In this API, blockNumber and kitNumberUTF added to return block number and kit number in UTF-8. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getQualifiedKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"startDate",
"in":"query",
"description":"Start date/time for retrieving qualified kit updates",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01T00:00:00.000Z"
},
{
"name":"endDate",
"in":"query",
"description":"End date/time for retrieving qualified kit updates",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-29T23:59:59.999Z"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDetailsExtTO"
}
},
"examples":{
"Get Qualified Kits Response":{
"description":"Get Qualified Kits Response",
"value":[
{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"inventoryStatus":"Available",
"blockNumber":"BLK-01",
"kitNumberUTF":"KIT-1001"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid date range",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventory-qualified-kits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventory-qualified-kits-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventorystatuses/receivedshipment":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get received inventory statuses"
],
"summary":"v2.0",
"description":"Retrieves received inventory status. Rights: OrsInventoryGet.",
"operationId":"getReceivedInventoryStatuses_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Received Inventory Statuses Response":{
"description":"Get Received Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
},
{
"inventoryStatusId":20,
"inventoryStatus":"Received for Destruction"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Received Inventory Statuses Not Found Response":{
"description":"Get Received Inventory Statuses Not Found Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Received Inventory Statuses Server Error Response":{
"description":"Get Received Inventory Statuses Server Error Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventorystatuses-receivedshipment-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventorystatuses-receivedshipment-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kits/{kitNumber}/history":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history by KitNumberUTF"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a site's kit history. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getSiteKitHistory_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"kitNumber",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"number"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kits-{kitNumber}-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kits-kitnumber-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kits/{inventoryId}/historyById":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history by ID"
],
"summary":"v2.0",
"description":"Retrieves a kit's history by ID. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getSiteKitHistoryById_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"b1b8327a-faa6-4122-8710-6192ab5984ef"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
}
},
"examples":{
"Get Kit History By ID Response":{
"description":"Get Kit History By ID Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available",
"reason":"Kit received",
"returnedUnits":0,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kits-{inventoryId}-historyById-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kits-inventoryid-historybyid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/barcode":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update a barcode"
],
"summary":"v2.0",
"description":"Updates a kit's barcode. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateBarcodes_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Kits to be updated with barcodes.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitNumberBarcodeTO"
}
},
"examples":{
"Update Barcodes Request":{
"description":"Update Barcodes Request",
"value":[
{
"kitNumber":1001,
"barcode":"61234"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/InventoryUpdatedTO"
},
"examples":{
"Update Barcodes Response":{
"description":"Update Barcodes Response",
"value":{
"inventoryUpdated":5
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found OR Inventory not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid Inventory Status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-barcode-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-barcode-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/inventory/kits":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit attributes"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Updates kit attributes. Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKitAttributes_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Kit attribute parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitAttributesRequestV2"
},
"examples":{
"Update Kit Attributes Request":{
"description":"Update Kit Attributes Request",
"value":{
"reason":"Inventory update",
"inventoryStatusId":1,
"labelGroupId":"LABEL-001",
"location":"SITE-001",
"manufacturingLotId":"LOT-001",
"materialId":"MAT-001",
"itemNumber":"ITEM-001",
"updateMaterialId":true,
"updateItemNumber":true,
"kits":[
"b1b8327a-faa6-4122-8710-6192ab5984ef"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitsResponseV1"
},
"examples":{
"Update Kit Attributes Response":{
"description":"Update Kit Attributes Response",
"value":{
"noOfRowsUpdated":10
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Specify at least one kit attribute OR Reason is required OR Specify at least one filter. OR Either kits or kitFilters is required OR Invalid kit status OR Invalid kit range filter OR Invalid lot OR Invalid label group in kit filters OR Invalid kit type OR Invalid location OR No kits to update OR Update kits retrieved size exceeds maximum rows for update limit OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitNumberUTF}/lastStatus":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get latest status of kit in site inventory"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves the latest status of a kit at a site. Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getKitLastStatus_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitNumberUTF",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-1001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusResponse"
},
"examples":{
"Get Site Kit Last Status Response":{
"description":"Get Site Kit Last Status Response",
"value":{
"inventoryStatusId":10,
"inventoryStatus":"Dispensed"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit Last Status Server Error Response":{
"description":"Get Site Kit Last Status Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving the site kit status."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit Last Status Not Found Response":{
"description":"Get Site Kit Last Status Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The site kit was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit Last Status Bad Request Response":{
"description":"Get Site Kit Last Status Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit number is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitNumberUTF}-lastStatus-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-inventory-kits-kitnumberutf-laststatus-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitNumber}/history":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history by kit number for a site"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Use latest version instead. Retrieves a kit's history at a site by kit number. Rights: OrsInventoryGet and OrsBlinded.",
"operationId":"getSiteKitHistory_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitNumber",
"in":"path",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"number"
},
"example":10001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
},
"examples":{
"Get Site Kit History By Kit Number Response":{
"description":"Get Site Kit History By Kit Number Response",
"value":{
"inventoryStatusId":5,
"inventoryStatus":"Available",
"reason":"Status updated during reconciliation",
"returnedUnits":10,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History By Kit Number Server Error Response":{
"description":"Get Site Kit History By Kit Number Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kit history."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History By Kit Number Not Found Response":{
"description":"Get Site Kit History By Kit Number Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kit history was found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History By Kit Number Bad Request Response":{
"description":"Get Site Kit History By Kit Number Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit number is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitNumber}-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-inventory-kits-kitnumber-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{inventoryId}/historyById":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history for a site by kitNumberUTF"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a kit's history at a site by inventory ID. Rights: OrsInventoryGet and OrsBlinded.",
"operationId":"getSiteKitHistoryById_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"inventoryId",
"in":"path",
"description":"ID of the inventory",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
},
"examples":{
"Get Site Kit History By Inventory ID Response":{
"description":"Get Site Kit History By Inventory ID Response",
"value":{
"inventoryStatusId":5,
"inventoryStatus":"Available",
"reason":"Status updated during reconciliation",
"returnedUnits":10,
"missingUnits":0,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History By Inventory ID Server Error Response":{
"description":"Get Site Kit History By Inventory ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kit history."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History By Inventory ID Not Found Response":{
"description":"Get Site Kit History By Inventory ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kit history was found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History By Inventory ID Bad Request Response":{
"description":"Get Site Kit History By Inventory ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site inventory identifier is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{inventoryId}-historyById-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-inventory-kits-inventoryid-historybyid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: ",
"operationId":"getSiteKits_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"schema":{
"type":"string"
},
"example":"KIT_NUMBER:10:100"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":[
5,
10
]
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponseV2"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"minKitNumber":10,
"maxKitNumber":100,
"totalReturnedUnits":2,
"distinctInventoryStatusIds":[
5,
10
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0,
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site",
"subjectId":"D313327EF13845169A8ADADDA435431E",
"packageTypeId":1,
"unitsPerKit":10,
"returnedUnits":2,
"missingUnits":0,
"balanceUnits":8,
"verified":1,
"lastModifiedDate":"2026-02-21T23:40:32.079Z",
"kitDescription":"Bottle of tablets",
"distributionSetting":"BLINDED"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Server Error Response":{
"description":"Get Site Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit number combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Not Found Response":{
"description":"Get Site Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kits were found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Bad Request Response":{
"description":"Get Site Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit filter values are invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update status for kits in a site"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Updates the status of a kit at a site. If the new status is quarantined it will generate a temperature excursion number.
Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Kits status update details.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Site Kits Response":{
"description":"Update Site Kits Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Site Kits Server Error Response":{
"description":"Update Site Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating site kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Site Kits Not Found Response":{
"description":"Update Site Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The site kit selection was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Site Kits Bad Request Response":{
"description":"Update Site Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kits update request is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitId}":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit status by kit ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Updates a kit's status at a site by kit ID. Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"kitId",
"in":"path",
"description":"ID of the kit.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Kits status update details.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Site Kit Response":{
"description":"Update Site Kit Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Site Kit Server Error Response":{
"description":"Update Site Kit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating the site kit."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Site Kit Not Found Response":{
"description":"Update Site Kit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The site kit was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Site Kit Bad Request Response":{
"description":"Update Site Kit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit update request is invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitId}-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-sites-siteid-inventory-kits-kitid-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit types"
],
"summary":"v2.0",
"description":"Retrieves kit types by study ID. Rights: OrsInventoryGet.",
"operationId":"getKitTypes_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"*/*":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTypesTOV2"
}
},
"examples":{
"Get Kit Types Response":{
"description":"Get Kit Types Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5,
"packageTypeKey":"INHALER"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Types Server Error Response":{
"description":"Get Kit Types Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving kit types.",
"details":{
"operation":"getKitTypes",
"reason":"The kit types could not be loaded."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-kit-types-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/lots/manufacturing-lots":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get all manufacturing lots"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves all manufacturing lots by study ID. Rights: LotManagementGet.",
"operationId":"getAllManufacturingLots_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":50
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records.",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ManufacturingLotTOV2"
}
},
"examples":{
"Get Manufacturing Lots Response":{
"description":"Get Manufacturing Lots Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"manufacturingLotNumber":"MLOT-2001",
"expirationDate":"2026-12-31T00:00:00Z",
"blindedLotId":"0A1B2C3D4E5F67890123456789ABCDEF",
"doNotCount":5,
"doNotShip":10,
"lotNumber":"LOT-2001",
"versionStart":"2026-01-15T09:30:00Z",
"userId":"C36A3197-FDEE-433F-B554-7EE83DE99E4B",
"runNumber":"run number 01",
"inUse":true,
"versionEnd":"2026-02-15T09:30:00Z",
"blindedLotVersionStart":"2026-01-10T09:30:00Z",
"operationType":"MODIFIED",
"objectVersionNumber":5,
"softwareVersionNumber":2,
"reason":"Lot details updated",
"comment":"Manufacturing lot updated after review"
}
]
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view manufacturing lots.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while retrieving manufacturing lots.",
"details":{
"operation":"getAllManufacturingLots",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-manufacturing-lots-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-manufacturing-lots-get"
},
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create manufacturing lot"
],
"summary":"v2.0",
"description":"Creates a manufacturing lot. Rights: LotManagementPost.",
"operationId":"createManufacturingLot_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotRequest"
},
"examples":{
"Create Manufacturing Lot Request":{
"description":"Create Manufacturing Lot Request",
"value":{
"manufacturingLotNumber":"MLOT-2001",
"lotNumber":"LOT-2001",
"expirationDate":"2026-12-31",
"doNotShip":10,
"doNotCount":5,
"quantity":100
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create Manufacturing Lot Response":{
"description":"Create Manufacturing Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to create manufacturing lots.",
"details":{
"right":"LotManagementPost",
"reason":"The current user does not have create access for manufacturing lots."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid expiration date. OR Manufacturing Lot Number already exists or Lot short name (lotNumber) already exists.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"The manufacturing lot request is invalid.",
"details":{
"field":"quantity",
"reason":"Quantity must be a positive whole number and expirationDate must use yyyy-MM-dd format."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while creating the manufacturing lot.",
"details":{
"operation":"createManufacturingLot",
"reason":"The manufacturing lot could not be created."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-manufacturing-lots-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-manufacturing-lots-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/lots/manufacturing-lots/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get manufacturing lot by ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves manufacturing lot by lot ID. Rights: LotManagementGet.",
"operationId":"getManufacturingLot_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records.",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManufacturingLotTOV2"
},
"examples":{
"Get Manufacturing Lot Response":{
"description":"Get Manufacturing Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"manufacturingLotNumber":"MLOT-2001",
"expirationDate":"2026-12-31T00:00:00Z",
"blindedLotId":"0A1B2C3D4E5F67890123456789ABCDEF",
"doNotCount":5,
"doNotShip":10,
"lotNumber":"LOT-2001",
"versionStart":"2026-01-15T09:30:00Z",
"userId":"C36A3197-FDEE-433F-B554-7EE83DE99E4B",
"runNumber":"run number 01",
"inUse":true,
"versionEnd":"2026-02-15T09:30:00Z",
"blindedLotVersionStart":"2026-01-10T09:30:00Z",
"operationType":"MODIFIED",
"objectVersionNumber":5,
"softwareVersionNumber":2,
"reason":"Lot details updated",
"comment":"Manufacturing lot updated after review"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view the manufacturing lot.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while retrieving the manufacturing lot.",
"details":{
"operation":"getManufacturingLot",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-manufacturing-lots-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update manufacturing lot by ID"
],
"summary":"v2.0",
"description":"Update manufacturing lot by a lot's ID. Rights: LotManagementPost.",
"operationId":"updateManufacturingLot_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotRequest"
},
"examples":{
"Update Manufacturing Lot Request":{
"description":"Update Manufacturing Lot Request",
"value":{
"manufacturingLotNumber":"MLOT-2001",
"lotNumber":"LOT-2001",
"expirationDate":"2027-06-30",
"doNotShip":15,
"doNotCount":3,
"quantity":120
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Manufacturing Lot Response":{
"description":"Update Manufacturing Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to update manufacturing lots.",
"details":{
"right":"LotManagementPost",
"reason":"The current user does not have update access for manufacturing lots."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid expiration date. OR Manufacturing Lot Number already exists or Lot short name (lotNumber) already exists.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"The manufacturing lot update request is invalid.",
"details":{
"field":"expirationDate",
"reason":"expirationDate must use yyyy-MM-dd format and quantity must be greater than zero."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while updating the manufacturing lot.",
"details":{
"operation":"updateManufacturingLot",
"reason":"The manufacturing lot could not be updated."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-lots-manufacturing-lots-id-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{subjectId}/replaceRand":{
"post":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Numbers/Replace randomization number for a subject"
],
"summary":"v2.0",
"description":"Replace Randomization Number of a subject. Rights: UnblindedPost or S2S Call.",
"operationId":"replaceRandomizationNumber",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandReplacementRequestV1"
},
"examples":{
"Replace Randomization Number Request":{
"description":"Replace Randomization Number Request",
"value":{
"allowRandNumberReplacement":true,
"replacementStartingPrefix":997,
"maxReplacements":5
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Replace Randomization Number Response":{
"description":"Replace Randomization Number Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
},
"404":{
"description":"For Invalid Subject ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Invalid subject id."
}
}
}
}
}
},
"400":{
"description":"For reaching max number of replacements or randomization replacement is turned off.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Randomization replacement is turned off or max replacements reached."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{subjectId}-replaceRand-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-subjectid-replacerand-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/reports/kits/blindedchainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Blinded Chain of Custody report"
],
"summary":"v2.0",
"description":"Retrieves the Kit Blinded Chain of Custody report. Rights: UnblindedChainofCustodyReportPost.",
"operationId":"getBlindedChainOfCustodyReport_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-reports-kits-blindedchainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-reports-kits-blindedchainofcustody-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/reports/kits/blindedInventory":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Inventory (Blinded) report"
],
"summary":"v2.0",
"description":"Retrieves the Kit Inventory (Blinded) report. Rights: BlindedInventoryReportPost.",
"operationId":"getBlindedInventoryReport_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
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},
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"description":"Validation error - Invalid search criteria.",
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"format":"uuid"
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"format":"uuid"
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],
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"400":{
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},
"404":{
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},
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"tags":[
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"description":"Retrieves the Kit Inventory (Unblinded) report. Rights: UnblindedInventoryReportPost.",
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"schema":{
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}
],
"requestBody":{
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"403":{
"description":"The study does not match any study in Clinical One.",
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"description":"Invalid search criteria",
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},
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},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/reports/unblinded-visit-schedule":{
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"summary":"v2.0",
"description":"Retrieves the Unblinded Visit Schedule report. This version includes new fields for Kit Replacement and Dispensed Date.
Rights: UnblindedSubjectVisitReport.",
"operationId":"getUnblindedVisitScheduleReport_1",
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"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
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],
"requestBody":{
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"content":{
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},
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"description":"Study not found.",
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}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-reports-unblinded-visit-schedule-post",
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},
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"tags":[
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"summary":"v2.0",
"description":"Retrieves all resupply groups created for a study.
Rights: SupplySettingRightsGet. Required sponsor roles are clinical supply manager and site manager.triggerWeeks and resupplyWeeks fields aren't needed for Min/Max strategies, so they're hidden when fetched.",
"operationId":"getResupplyGroups_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
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"example":"test"
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{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
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"schema":{
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"format":"uuid"
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"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
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{
"name":"resupplyTypeId",
"in":"query",
"description":"ID of resupply type.",
"required":true,
"schema":{
"type":"integer",
"format":"int32",
"enum":[
null
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},
"example":1
},
{
"name":"type",
"in":"query",
"description":"Type of resupply.",
"schema":{
"type":"string",
"enum":[
"Site,Depot"
]
},
"example":"Site"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
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"schema":{
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"description":"Get Resupply Groups Response",
"value":{
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{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"name":"Site Resupply Group",
"type":"Site",
"resupplyTypeId":1
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}
}
}
}
}
},
"404":{
"description":"Resupply not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
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"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Resupply groups not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
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"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
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"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
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}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupplies-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupplies-get"
},
"post":{
"tags":[
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],
"summary":"v2.0",
"description":"Creates a resupply group for a study.
Rights: SupplySettingRightsPost
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"createResupplyGroup_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupRequest"
},
"examples":{
"Create Resupply Group Request":{
"description":"Create Resupply Group Request",
"value":{
"name":"Site Resupply Group",
"type":"Site",
"resupplyTypeId":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation"
},
"400":{
"description":"'Invalid resupply type', 'Duplicate resupply'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid resupply group request."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
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}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupplies-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupplies-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/resupplies/{resupplyId}":{
"get":{
"tags":[
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],
"summary":"v2.0",
"description":"Retrieves a resupply group by ID.
Rights: SupplySettingRightsGet. Required sponsor roles are clinical supply manager and site manager.",
"operationId":"getResupplyGroup_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"resupplyId",
"in":"path",
"description":"ID of resupply group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupResponseV2"
},
"examples":{
"Get Resupply Group Response":{
"description":"Get Resupply Group Response",
"value":{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"name":"Site Resupply Group",
"type":"Site",
"resupplyTypeId":1
}
}
}
}
}
},
"404":{
"description":"Resupply not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Resupply group not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupplies-{resupplyId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupplies-resupplyid-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Update a resupply by ID"
],
"summary":"v2.0",
"description":"Updates a resupply group by ID.
Rights: SupplySettingRightsPost
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"updateResupplyGroup_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"resupplyId",
"in":"path",
"description":"ID of resupply group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupRequest"
},
"examples":{
"Update Resupply Group Request":{
"description":"Update Resupply Group Request",
"value":{
"name":"Site Resupply Group",
"type":"Site",
"resupplyTypeId":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation"
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Resupply group not found."
}
}
}
}
}
},
"400":{
"description":"'Validation error, 'Invalid resupply type', 'Resupply already exists', 'Resupply contains duplicate IDs for kit types', 'Invalid kit type'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid resupply group request."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-resupplies-{resupplyId}-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-resupplies-resupplyid-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/{studyVersion}/randlist/generate":{
"post":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Create randomization list"
],
"summary":"v2.0",
"description":"Generates a randomization list in the study; Rights: DesignerRandListPost.",
"operationId":"create_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"studyVersion",
"in":"path",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CommonGenerateRndListRequest"
},
"examples":{
"Generate Randomization List Request":{
"description":"Generate Randomization List Request",
"value":{
"name":"RandList-01",
"noOfRows":5
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateResponse"
},
"examples":{
"Generate Randomization List Response":{
"description":"Generate Randomization List Response",
"value":{
"listId":"9ECA4FA65076451DA7D47D59367D15A5",
"noOfRowsGenerated":5
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
},
"404":{
"description":"For Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Study version not found."
}
}
}
}
}
},
"400":{
"description":"For algorithm not defined for the randomization design or randomization design not associated with a visit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid request."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-{studyVersion}-randlist-generate-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-studyversion-randlist-generate-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/randlists/{rndlistid}/randnumbers":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Numbers/Get randomization number"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves randomization numbers for a randomization list. Supports searchString, limit, offset, blockedBy and status filters. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandNum",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"9ECA4FA65076451DA7D47D59367D15A5"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"schema":{
"type":"string"
},
"example":1001
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"blockedBy",
"in":"query",
"description":"ID of the entity which has blocked the randomization number.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"status",
"in":"query",
"description":"Status of the randomization number.",
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandNumberResponse"
},
"examples":{
"Get Randomization Numbers Response":{
"description":"Get Randomization Numbers Response",
"value":{
"randNumbers":[
{
"sequenceNumber":1001
}
],
"offset":0,
"limit":100
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version, or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Randomization list not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-randlists-{rndlistid}-randnumbers-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-randlists-rndlistid-randnumbers-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/randlists":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a randomization list. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlist_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandListTOV2"
}
},
"examples":{
"Get Randomization Lists Response":{
"description":"Get Randomization Lists Response",
"value":[
{
"randListId":"9ECA4FA65076451DA7D47D59367D15A5",
"name":"RandList-01",
"description":"Randomization list for study.",
"isBlocked":"n",
"isDynamic":"n",
"isStratified":"y",
"inUse":"y",
"isCohortBased":"y"
}
]
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Randomization lists not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-randlists-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-randlists-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/randlists/{rndlistid}":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list by ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a randomization list by ID. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlistById_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"9ECA4FA65076451DA7D47D59367D15A5"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTOV2"
},
"examples":{
"Get Randomization List By Id Response":{
"description":"Get Randomization List By Id Response",
"value":{
"randListId":"9ECA4FA65076451DA7D47D59367D15A5",
"name":"RandList-01",
"description":"Randomization list for study.",
"isBlocked":"n",
"isDynamic":"n",
"isStratified":"y",
"inUse":"y",
"isCohortBased":"y"
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Randomization list not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-randlists-{rndlistid}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-randlists-rndlistid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/randlistdesigns":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Designs/Get randomization design list"
],
"summary":"v2.0",
"description":"Retrieves a randomization design list. Rights: OrsRandListGet, OrsUnblinded. Added new field: randomizationSeed.",
"operationId":"getRandomizationListDesigns_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RndListDesignList"
}
},
"examples":{
"Get Randomization List Designs Response":{
"description":"Get Randomization List Designs Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"RndListDesign-01"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Randomization list designs not found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-randlistdesigns-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-randlistdesigns-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a kit's details by order. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":10001
},
{
"name":"orderBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered.",
"required":true,
"schema":{
"type":"string"
},
"example":"kitNumber"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentKitsResponseV2"
},
"examples":{
"Get Shipment Kits Response":{
"description":"Get Shipment Kits Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"kits":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitNumber":5,
"sequenceNumber":5,
"barcode":"KIT-000005"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-kits-get"
},
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Add kits to a shipment"
],
"summary":"v2.0",
"description":"Adds kits to an order shipment. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"addKitsToShipment_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"requestBody":{
"description":"Kits to be added to the shipment.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentAddKitsRequest"
},
"examples":{
"Add Kits To Shipment Request":{
"description":"Add Kits To Shipment Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Add Kits Response":{
"description":"Add Kits Response",
"value":"89EE76326E984B548D594D592E5C7FC2"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-kits-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/orders-inventory/audit":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order items"
],
"summary":"v2.0",
"description":"Retrieves all order items.
Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getAllOrderItems_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"required":true,
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"required":true,
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderItemResponse"
}
},
"examples":{
"Get Order Items Response":{
"description":"Get Order Items Response",
"value":[
{
"hasMore":false,
"totalResults":1,
"count":1,
"limit":100,
"offset":0,
"resultData":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"inventoryVersionStart":"2026-02-21T06:30:00Z",
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderVersionStart":"2026-02-21T06:30:00Z",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"DATA ENTRY ERROR",
"comment":"Created order item.",
"orderItemId":"5BB2C53538C841268AB4E4A1E640D0C9"
}
]
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
},
"400":{
"description":"Bad request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request parameters."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-orders-inventory-audit-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-orders-inventory-audit-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments/{shipmentId}/eligible-kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get eligible kits"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Searches for kits by kit type or shipment details. Rights: OrsInventoryGet, OrsUnblinded. Added additional field kitNumberUTF in the response",
"operationId":"getEligibleKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentEligibleKitsResponseV2"
},
"examples":{
"Get Eligible Kits Response":{
"description":"Get Eligible Kits Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"kits":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitNumber":5,
"sequenceNumber":5,
"kitTypeName":"Kit A"
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-eligible-kits-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-eligible-kits-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryDTOV2"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"D313327EF13845169A8ADADDA435431E",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Order not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-orders-shipmentid-get"
},
"put":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Update shipment details for an order"
],
"summary":"v2.0",
"description":"Updates shipment details with deliveryNumber for an order. Rights: OrsInventoryPost, OrsUnblinded.",
"operationId":"setOrderShipment_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-000123"
}
],
"requestBody":{
"description":"Order shipment details.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/OrderShipmentDTO"
},
"examples":{
"Set Order Shipment Request":{
"description":"Set Order Shipment Request",
"value":{
"shipDate":"2026-02-24T00:00:00Z",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"deliveryNumber":"12345",
"updateDeliveryNumber":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"examples":{
"Set Order Shipment Response":{
"description":"Set Order Shipment Response",
"value":{
"status":"success",
"result":{
"shipmentId":"SHIP-000123",
"shipmentStatus":"SHIPPED"
},
"errorData":null,
"version":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"Invalid shipment type",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-orders-{shipmentId}-put",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-orders-shipmentid-put"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Searches for orders in a given date range matching a status. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderInventoryDTOV2"
}
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"D313327EF13845169A8ADADDA435431E",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request parameters."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get shipment by shipment ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves shipment by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipment_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentTOV2"
},
"examples":{
"Get Shipment Response":{
"description":"Get Shipment Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"shipmentNumber":"SHIP-0001",
"statusId":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipments_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-0001"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"siteId",
"in":"query",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV2"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"shipmentNumber":"SHIP-0001",
"statusId":1,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"No data found."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipment-statuses":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/List available order status values"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves a list of available order status values. Rights: OrsInventoryGet.",
"operationId":"getStatuses_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderStatus"
}
},
"examples":{
"Get Shipment Statuses Response":{
"description":"Get Shipment Statuses Response",
"value":[
{
"id":1,
"status":"PENDING"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipment-statuses-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipment-statuses-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments/{shipmentId}/received":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Mark kits as received"
],
"summary":"v2.0",
"description":"Marks kits as received in a study's inventory. Rights: OrsInventoryPost and DepotShipmentReceiptPost/OrsBlinded.",
"operationId":"markSiteOrDepotShipmentReceived_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"requestBody":{
"description":"Kits to be assigned.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedRequest"
},
"examples":{
"Mark Shipment Received Request":{
"description":"Mark Shipment Received Request",
"value":{
"receivedDate":"2026-02-21",
"comment":"Received at site"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedResponse"
},
"examples":{
"Mark Shipment Received Response":{
"description":"Mark Shipment Received Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"status":"RECEIVED"
}
}
}
}
}
},
"400":{
"description":"'Invalid order status', 'Invalid kit'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-received-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-received-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments/{shipmentId}/quarantined":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Quarantine/Update shipment and its kits as quarantined"
],
"summary":"v2.0",
"description":"Updates the shipment and its kits as quarantined. Rights: OrsInventoryPost, DepotShipmentReceiptPost/OrsBlinded.",
"operationId":"quarantineShipment_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"requestBody":{
"description":"Quarantine shipment request body.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentQuarantineRequestV1"
},
"examples":{
"Quarantine Shipment Request":{
"description":"Quarantine Shipment Request",
"value":{
"tempMonitorStatus":"missing"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentQuarantineResponseV1"
},
"examples":{
"Quarantine Shipment Response":{
"description":"Quarantine Shipment Response",
"value":{
"tempExcursionNumber":"001",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Quarantine Shipment Server Error Response":{
"description":"Quarantine Shipment Server Error Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"quarantineShipment",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2"
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Quarantine Shipment Not Found Response":{
"description":"Quarantine Shipment Not Found Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"reason":"No shipment matched the supplied identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"'Invalid Kit', 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Quarantine Shipment Bad Request Response":{
"description":"Quarantine Shipment Bad Request Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid shipment quarantine request.",
"details":{
"field":"tempMonitorStatus",
"issue":"Allowed values are yes, no, or missing."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-quarantined-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-quarantined-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments/{shipmentId}/receive-quarantined":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Quarantine/Update a quarantined shipment and its kits to received"
],
"summary":"v2.0",
"description":"Updates a quarantine shipment and its kits. Rights: DepotQuarantinePost.",
"operationId":"quarantinedShipmentToReceived_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"requestBody":{
"description":"Kits to be damaged.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/QuarantinedToReceivedRequest"
},
"examples":{
"Receive Quarantined Shipment Request":{
"description":"Receive Quarantined Shipment Request",
"value":{
"damagedKits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"updateNSKits":[
{
"lotId":"D313327EF13845169A8ADADDA435431E",
"kitTypeId":"89EE76326E984B548D594D592E5C7FC2",
"inventoryStatusId":2,
"quantity":5
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/QuarantinedToReceivedResponseV1"
},
"examples":{
"Receive Quarantined Shipment Response":{
"description":"Receive Quarantined Shipment Response",
"value":{
"receivedDate":"2026-02-24T00:00:00Z",
"availableCount":98,
"damagedCount":2
}
}
}
}
}
},
"400":{
"description":"'Invalid Kit', 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Receive Quarantined Shipment Bad Request Response":{
"description":"Receive Quarantined Shipment Bad Request Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"field":"damagedKits",
"issue":"One or more kits do not belong to the quarantined shipment."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Receive Quarantined Shipment Not Found Response":{
"description":"Receive Quarantined Shipment Not Found Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"reason":"No shipment matched the supplied identifier."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Receive Quarantined Shipment Server Error Response":{
"description":"Receive Quarantined Shipment Server Error Response",
"value":{
"status":"ERROR",
"version":2,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"quarantinedShipmentToReceived",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2"
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-receive-quarantined-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-receive-quarantined-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/shipments/{shipmentId}/removeKits":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Remove kits from a shipment"
],
"summary":"v2.0",
"description":"Removes both serialized and non-serialized kits from an order shipment. Rights: OrsInventoryDelete, OrsUnblinded.",
"operationId":"removeKitsFromShipmentPost_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"requestBody":{
"description":"Kits to be removed from the shipment.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ShipmentRemoveKitsRequest"
},
"examples":{
"Remove Kits From Shipment Request":{
"description":"Remove Kits From Shipment Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string",
"format":"uuid"
},
"examples":{
"Remove Kits Response":{
"description":"Remove Kits Response",
"value":"89EE76326E984B548D594D592E5C7FC2"
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
},
"400":{
"description":"'Invalid Kit', 'Invalid shipment status'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"message":"Invalid request payload."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-shipments-{shipmentId}-removeKits-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-shipments-shipmentid-removekits-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{subjectId}/titration-eligible":{
"get":{
"tags":[
"Randomization and Supplies/Titration APIs/Check if subject is eligible for titration"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Checks if subject is eligible for titration. This is a new version of the API for returning additional attributes for titration kit label. Rights: OrsSubjectVisitGet.",
"operationId":"isTitrationAllowedForSubject_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"query",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitKitTypeTO"
}
},
"examples":{
"Titration Eligible Response":{
"description":"Titration Eligible Response",
"value":[
{
"titrationId":"B1B8327AFAA6412287106192AB5984EF",
"status":"ALLOW",
"isUpAllowed":true,
"isDownAllowed":true,
"kitsDispensed":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
]
}
}
}
}
},
"400":{
"description":"For a subject who cannot be titrated as there are no titration kits dispensed to the subject earlier OR Subject cannot be titrated as no matching kits are defined with subject dispensations. ORInvalid subject OR Missing subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"errorCode":"INVALID_REQUEST",
"message":"Invalid request."
}
}
}
}
}
},
"404":{
"description":"Visit not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"errorCode":"NOT_FOUND",
"message":"Resource not found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"errorCode":"SERVER_ERROR",
"message":"Unexpected error."
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{subjectId}-titration-eligible-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-subjectid-titration-eligible-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{subjectId}/allowed-doseholds":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get kits allowed for dose hold"
],
"summary":"v2.0",
"description":"Get kits allowed for dose hold in the current visit for a given subject. Rights: OrsSubjectVisitGet.",
"operationId":"getAllowedDoseHold_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"query",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldKitsResponse"
},
"examples":{
"Allowed Dose Holds Response":{
"description":"Allowed Dose Holds Response",
"value":{
"status":"ALLOW_DOSE_HOLD",
"kitsAllowedForDoseHold":[
{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"trialSupplyType":"BOTTLE",
"isTitration":true
}
],
"kitsNotAllowedForDoseHold":[
{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"kitDescription":"Kit B",
"trialSupplyType":"DEVICE",
"isTitration":false,
"reason":"DOSE_HOLD_NOT_ALLOWED_ON_ANY_KITS"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Allowed Dose Holds Bad Request Response":{
"description":"Allowed Dose Holds Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-400",
"errorMessage":"The allowed dose holds request is invalid.",
"details":{
"field":"studyVersion",
"reason":"The study version is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Allowed Dose Holds Server Error Response":{
"description":"Allowed Dose Holds Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-500",
"errorMessage":"Unexpected error while retrieving allowed dose holds.",
"details":{
"operation":"getAllowedDoseHold",
"reason":"The dose hold evaluation failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{subjectId}-allowed-doseholds-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-subjectid-allowed-doseholds-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/codebreak":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get code break"
],
"summary":"v2.0",
"description":"Retrieves code break. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeBreak_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Code view parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewRequest"
},
"examples":{
"Code Break Request":{
"description":"Code Break Request",
"value":{
"adverseEvent":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewResponse"
},
"examples":{
"Code Break Response":{
"description":"Code Break Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"description":"Randomized successfully",
"externalTreatmentId":"TA",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4
}
],
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":2,
"packageType":"BOTTLE"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found. Or site ID not found in site service",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Not Found Response":{
"description":"Code Break Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Code break information was not found for the subject.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have code break data."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Bad Request Response":{
"description":"Code Break Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The code break request is invalid.",
"details":{
"field":"adverseEvent",
"reason":"The adverse event flag must be 0 or 1."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Server Error Response":{
"description":"Code Break Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving code break information.",
"details":{
"operation":"getCodeBreak",
"reason":"The code break lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-codebreak-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-srcsubjectid-codebreak-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/codeview":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get code view"
],
"summary":"v2.0",
"description":"Retrieves code view. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeView_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Code view parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewRequest"
},
"examples":{
"Code View Request":{
"description":"Code View Request",
"value":{
"adverseEvent":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewResponse"
},
"examples":{
"Code View Response":{
"description":"Code View Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"description":"Randomized successfully",
"externalTreatmentId":"TA",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4
}
],
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":2,
"packageType":"BOTTLE"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Not Found Response":{
"description":"Code View Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"Code view information was not found for the subject.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have code view data."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Bad Request Response":{
"description":"Code View Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The code view request is invalid.",
"details":{
"field":"adverseEvent",
"reason":"The adverse event flag must be 0 or 1."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Server Error Response":{
"description":"Code View Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving code view information.",
"details":{
"operation":"getCodeView",
"reason":"The code view lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-codeview-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-srcsubjectid-codeview-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves dispensation history. Rights: OrsSubjectVisitGet.",
"operationId":"getDispensationHistory_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"externalSubjectId",
"in":"path",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"visitId",
"in":"query",
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponseV2"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":10001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:45:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitDescription":"Bottle of tablets"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Not Found Response":{
"description":"Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No dispensation history was found for the subject visit.",
"details":{
"field":"externalSubjectId",
"reason":"The subject does not have dispensation history for the supplied visit."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Bad Request Response":{
"description":"Dispensation History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The dispensation history request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Server Error Response":{
"description":"Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving dispensation history.",
"details":{
"operation":"getDispensationHistory",
"reason":"The dispensation history lookup could not be completed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/randomization-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get randomization history"
],
"summary":"v2.0",
"description":"Retrieves randomization history. Rights: OrsSubjectVisitGet. Added new field: visit ID.",
"operationId":"getRandomizationHistory_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationHistoryResponse"
}
},
"examples":{
"Randomization History Response":{
"description":"Randomization History Response",
"value":[
{
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"visitId":"B1B8327AFAA6412287106192AB5984EF"
}
]
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Randomization History Not Found Response":{
"description":"Randomization History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No randomization history was found for the subject.",
"details":{
"field":"externalSubjectId",
"reason":"The subject has not been randomized."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Randomization History Server Error Response":{
"description":"Randomization History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving randomization history.",
"details":{
"operation":"getRandomizationHistory",
"reason":"The randomization history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-randomization-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-externalsubjectid-randomization-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{subjectId}/reuse-kits":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get reusable kits from a list of kit types"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves previously dispensed kits, from a list of kit types passed in the request body, that can be reused in the current visit for a given subject. Support for unblinded pharmacist kits which are put on dose hold. Rights: OrsSubjectVisitGet.",
"operationId":"getReusableDoseHoldKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Contains details for getting reusable kits.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDoseHoldRequest"
},
"examples":{
"Reusable Kits Request":{
"description":"Reusable Kits Request",
"value":{
"studyVersion":"1.0",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"titrationOption":"up",
"kitTypesForDoseHold":[
{
"kitTypeSrcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"trialSupplyType":"BOTTLE",
"deviceType":"Spirometer",
"isTitration":true
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReusableKitsResponseV1"
},
"examples":{
"Reusable Kits Response":{
"description":"Reusable Kits Response",
"value":{
"status":"ALLOW",
"kits":[
{
"id":2,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"kitDescription":"Kit A"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Bad Request Response":{
"description":"Reusable Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The reusable kits request is invalid.",
"details":{
"field":"subjectId",
"reason":"The subject identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Server Error Response":{
"description":"Reusable Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving reusable kits.",
"details":{
"operation":"getReusableDoseHoldKits",
"reason":"The reusable kits lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{subjectId}-reuse-kits-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-subjectid-reuse-kits-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{subjectId}/doseheld":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get kits which are marked as dose hold"
],
"summary":"v2.0",
"description":"Get kits which are marked as dose hold in the current visit. Rights: OrsSubjectVisitGet.",
"operationId":"getSubjectVisitDoseHeldKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldKitV2"
},
"examples":{
"Dose Held Kits Response":{
"description":"Dose Held Kits Response",
"value":{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"trialSupplyType":"BOTTLE",
"isTitration":true
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held Kits Bad Request Response":{
"description":"Dose Held Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-400",
"errorMessage":"The dose held kits request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held Kits Server Error Response":{
"description":"Dose Held Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"DOSE-500",
"errorMessage":"Unexpected error while retrieving dose held kits.",
"details":{
"operation":"getSubjectVisitDoseHeldKits",
"reason":"The dose held kits lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{subjectId}-doseheld-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-subjectid-doseheld-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/unblinded-disp-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded dispensation history for all subjects"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Retrieves unblinded dispensation history for all subjects within the study. Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedAllDispHistory_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string"
},
"example":"SUBJ-001"
},
{
"name":"audit",
"in":"query",
"description":"Value of audit parameter",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DispensationHistoryResponseForAllSubjectV2"
},
"examples":{
"Unblinded Dispensation History Response":{
"description":"Unblinded Dispensation History Response",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"siteId":"D313327EF13845169A8ADADDA435431E",
"inventoryId":"E39FF55A445543A38D513325664F0B2D",
"kitNumber":10001,
"inventoryStatus":"Available",
"dispensationDate":"2026-02-21T06:45:00Z"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Not Found Response":{
"description":"Unblinded Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No unblinded dispensation history was found.",
"details":{
"field":"subjectId",
"reason":"No dispensation records matched the supplied filters."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Server Error Response":{
"description":"Unblinded Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded dispensation history.",
"details":{
"operation":"getUnblindedAllDispHistory",
"reason":"The dispensation history lookup failed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-unblinded-disp-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-unblinded-disp-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/unblinded-disp-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded dispensation history"
],
"summary":"v2.0",
"description":"Retrieves history of unblinded dispensation for a subject within the study. Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedDispensationHistory_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UnblindedDispensationHistoryDTO"
},
"examples":{
"Unblinded Dispensation History By Subject Response":{
"description":"Unblinded Dispensation History By Subject Response",
"value":{
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Bottle kit",
"packageTypeId":2,
"packageType":"BOTTLE",
"dispensationDetails":[
{
"kitNumber":10001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:45:00Z"
}
]
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History By Subject Not Found Response":{
"description":"Unblinded Dispensation History By Subject Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No unblinded dispensation history was found for the subject.",
"details":{
"field":"srcSubjectId",
"reason":"The subject has no dispensed kits for the supplied visit."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History By Subject Bad Request Response":{
"description":"Unblinded Dispensation History By Subject Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The unblinded dispensation history request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History By Subject Server Error Response":{
"description":"Unblinded Dispensation History By Subject Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded dispensation history for the subject.",
"details":{
"operation":"getUnblindedDispensationHistory",
"reason":"The dispensation history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-unblinded-disp-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-srcsubjectid-unblinded-disp-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/unblinded-rand-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded randomization history"
],
"summary":"v2.0",
"description":"Retrieves unblinded randomization history. Rights: OrsSubjectVisitGet. Added new field: Cohort ID.",
"operationId":"getUnblindedRandHistory_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UnblindedRandomizationHistoryDTOV2"
},
"examples":{
"Unblinded Randomization History Response":{
"description":"Unblinded Randomization History Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4,
"description":"Treatment Arm A",
"externalTreatmentId":"TA",
"visitId":"D313327EF13845169A8ADADDA435431E"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History Not Found Response":{
"description":"Unblinded Randomization History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No unblinded randomization history was found.",
"details":{
"field":"srcSubjectId",
"reason":"The subject has no unblinded randomization history."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History Server Error Response":{
"description":"Unblinded Randomization History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded randomization history.",
"details":{
"operation":"getUnblindedRandHistory",
"reason":"The randomization history lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-unblinded-rand-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-srcsubjectid-unblinded-rand-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/unblinded-rand-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded randomization history for all subjects"
],
"summary":"v2.0",
"description":"Retrieves unblinded randomization history for all subjects within the study. Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedRandHistoryForAllSubjects_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string"
},
"example":"SUBJ-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UnblindedRandomizationHistoryDTOV2"
},
"examples":{
"Unblinded Randomization History For All Subjects Response":{
"description":"Unblinded Randomization History For All Subjects Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"randNumber":1001,
"randomizationDate":"2026-02-21T06:45:00Z",
"rndStatusId":4,
"description":"Treatment Arm A",
"externalTreatmentId":"TA",
"visitId":"D313327EF13845169A8ADADDA435431E"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History For All Subjects Not Found Response":{
"description":"Unblinded Randomization History For All Subjects Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"No unblinded randomization history was found for the supplied filters.",
"details":{
"field":"subjectId",
"reason":"No randomization records matched the request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Randomization History For All Subjects Server Error Response":{
"description":"Unblinded Randomization History For All Subjects Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving unblinded randomization history for all subjects.",
"details":{
"operation":"getUnblindedRandHistoryForAllSubjects",
"reason":"The randomization history query failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-unblinded-rand-history-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-unblinded-rand-history-get"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit by its visit ID. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"externalSubjectId",
"in":"query",
"schema":{
"type":"string"
}
},
{
"name":"visitId",
"in":"query",
"schema":{
"type":"string"
}
},
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV2"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"visitTimestamp":"2026-02-21T06:45:00Z",
"treatmentTitle":"A",
"kits":[
{
"id":2,
"kitDescription":"Kit A"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Not Found Response":{
"description":"Get Visit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"The requested subject visit was not found.",
"details":{
"field":"externalSubjectId",
"reason":"No subject visit matched the supplied subject and visit identifiers."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Bad Request Response":{
"description":"Get Visit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The get visit request is invalid.",
"details":{
"field":"visitId",
"reason":"The visit identifier is not valid."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Server Error Response":{
"description":"Get Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while retrieving the subject visit.",
"details":{
"operation":"getVisit",
"reason":"The visit lookup could not be completed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Randomize a subject and/or dispense kits during a randomization or dispensation visit. Rights: OrsVisitManagementPost.",
"operationId":"visit_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"studyId",
"in":"path",
"required":true,
"schema":{
"type":"string"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequest"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"D313327EF13845169A8ADADDA435431E",
"visitTimestamp":"2026-02-21 06:45:00",
"studyVersion":"1.0.0.5"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV2"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"visitTimestamp":"2026-02-21T06:45:00Z",
"treatmentTitle":"A",
"kits":[
{
"id":2,
"kitDescription":"Kit A"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Not Found Response":{
"description":"Visit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"The subject visit was not found.",
"details":{
"field":"visitId",
"reason":"The subject is not assigned to the supplied visit."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Bad Request Response":{
"description":"Visit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The visit request is invalid.",
"details":{
"field":"subjectId",
"reason":"The subject identifier is invalid."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Server Error Response":{
"description":"Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while processing the visit.",
"details":{
"operation":"visit",
"reason":"The visit could not be completed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/visits/migrateDispensation":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Migrate dispensation"
],
"summary":"v2.0",
"description":"Migrates dispensation records",
"operationId":"migrationDispensation_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/MigrationRequestV2"
},
"examples":{
"Migrate Dispensation Request":{
"description":"Migrate Dispensation Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"studyVersion":"1.0.0.5",
"kits":[
{
"sequenceNumber":10001,
"statusId":4,
"locationId":"B1B8327AFAA6412287106192AB5984EF",
"dispensationTimeStamp":"2026-02-21 06:45:00"
}
],
"randomNumber":1001,
"randomizationListId":"D313327EF13845169A8ADADDA435431E",
"visitTimestamp":"2026-02-21 06:45:00"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/Response"
},
"examples":{
"Migrate Dispensation Response":{
"description":"Migrate Dispensation Response",
"value":{
"randomNumber":"1001",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"quantity":1,
"inventoryId":"D313327EF13845169A8ADADDA435431E"
}
],
"visitTimestamp":"2026-02-21T06:45:00Z",
"treatmentTitle":"TA"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Migrate Dispensation Server Error Response":{
"description":"Migrate Dispensation Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while migrating dispensation data.",
"details":{
"operation":"migrationDispensation",
"reason":"The migration request could not be completed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-visits-migrateDispensation-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-visits-migratedispensation-post"
}
},
"/ec-ors-svc/rest/v2.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/replacekits":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Replace a subject's kits"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Replaces a subject's kits in the system, accepts Strings and Numbers. Rights: OrsVisitManagementPost.",
"operationId":"replaceSubjectKits_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"description":"Subject replace kits parameters.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsRequest"
},
"examples":{
"Replace Subject Kits Request":{
"description":"Replace Subject Kits Request",
"value":{
"kits":[
"5a"
],
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Damaged kit replacement",
"reasonLabel":"kits are damaged"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsResponse"
},
"examples":{
"Replace Subject Kits Response":{
"description":"Replace Subject Kits Response",
"value":{
"replacedKits":[
{
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"quantity":1
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found. Or site ID not found in site service",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Not Found Response":{
"description":"Replace Subject Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-404",
"errorMessage":"The subject kits to replace were not found.",
"details":{
"field":"srcSubjectId",
"reason":"The subject does not have matching kits for replacement."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or this operation is not allowed during the current subject statusOr invalid kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Bad Request Response":{
"description":"Replace Subject Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-400",
"errorMessage":"The subject kit replacement request is invalid.",
"details":{
"field":"kits",
"reason":"At least one replacement kit must be supplied."
}
}
}
}
}
}
}
},
"500":{
"description":"Subject is randomized in error. Or not enough inventory",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Server Error Response":{
"description":"Replace Subject Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"VISIT-500",
"errorMessage":"Unexpected error while replacing subject kits.",
"details":{
"operation":"replaceSubjectKits",
"reason":"The replacement could not be completed."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v2.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-replacekits-post",
"x-filename-id":"ec-ors-svc-rest-v2.0-studies-studyid-mode-subjects-srcsubjectid-replacekits-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/lots/blinded-lots":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get blinded lots"
],
"summary":"v3.0",
"description":"Retrieves all blinded lots with release depot to depot settings.
To get a specific lot see Get blinded lot by ID.",
"operationId":"getAllBlindedLots_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":50
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsResponseV3"
},
"examples":{
"Get Blinded Lots Response":{
"description":"Get Blinded Lots Response",
"value":{
"blindedLots":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31T00:00:00Z",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"versionStart":"2026-02-21T06:30:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionEnd":"2026-02-21T06:45:00Z",
"operationType":"UPDATE",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"Audit",
"comment":"Updated blinded lot details",
"inUse":true,
"settingsByCountry":[
{
"id":"A36A3197FDEE433FB5547EE83DE99E4B",
"countryIso":"US",
"doNotCount":10,
"doNotShip":50,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionStart":"2026-02-21T06:30:00Z"
}
],
"releaseForDepotToDepot":true
}
]
}
}
}
}
}
},
"404":{
"description":"Blinded lot not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsResponseV3"
},
"examples":{
"Get Blinded Lots Not Found Response":{
"description":"Get Blinded Lots Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinded lot was not found.",
"details":{
"field":"blindedLotId",
"reason":"No blinded lot matched the supplied identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"v3.0 The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsResponseV3"
},
"examples":{
"Get Blinded Lots Bad Request Response":{
"description":"Get Blinded Lots Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot request is invalid.",
"details":{
"field":"includeDeleted",
"reason":"The blinded lot query parameters are invalid."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-blinded-lots-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-blinded-lots-get"
},
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create blinded lot"
],
"summary":"v3.0",
"description":"Creates blinded lot with release depot to depot settings.",
"operationId":"createBlindedLot_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/releaseForDepotToDepot"
},
"examples":{
"Create Blinded Lot Request":{
"description":"Create Blinded Lot Request",
"value":{
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
],
"releaseForDepotToDepot":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create Blinded Lot Response":{
"description":"Create Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Blinded lot not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create Blinded Lot Not Found Response":{
"description":"Create Blinded Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The study or randomization design was not found.",
"details":{
"field":"studyId",
"reason":"The blinded lot could not be created because the study context was not found."
}
}
}
}
}
}
}
},
"400":{
"description":"v3.0 The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create Blinded Lot Bad Request Response":{
"description":"Create Blinded Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot request is invalid.",
"details":{
"field":"manufacturingLotIds",
"reason":"At least one valid manufacturing lot identifier must be supplied."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-blinded-lots-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-blinded-lots-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/lots/blinded-lots/{blindedLotId}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get blinded lot by ID"
],
"summary":"v3.0",
"description":"Retrieves blinded lot by ID, with release depot to depot settings.
To get all blinded lots see Get blinded lots.",
"operationId":"getBlindedLot_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"blindedLotId",
"in":"path",
"description":"ID of blinded lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsResponseV3"
},
"examples":{
"Get Blinded Lot By ID Response":{
"description":"Get Blinded Lot By ID Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31T00:00:00Z",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"versionStart":"2026-02-21T06:30:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionEnd":"2026-02-21T06:45:00Z",
"operationType":"UPDATE",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"Audit",
"comment":"Updated blinded lot details",
"inUse":true,
"settingsByCountry":[
{
"id":"A36A3197FDEE433FB5547EE83DE99E4B",
"countryIso":"US",
"doNotCount":10,
"doNotShip":50,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"versionStart":"2026-02-21T06:30:00Z"
}
],
"releaseForDepotToDepot":true
}
}
}
}
}
},
"404":{
"description":"Blinded lot not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsResponseV3"
},
"examples":{
"Get Blinded Lot By ID Not Found Response":{
"description":"Get Blinded Lot By ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinded lot was not found.",
"details":{
"field":"blindedLotId",
"reason":"No blinded lot matched the supplied identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"v3.0 The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BlindedLotsResponseV3"
},
"examples":{
"Get Blinded Lot By ID Bad Request Response":{
"description":"Get Blinded Lot By ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot request is invalid.",
"details":{
"field":"blindedLotId",
"reason":"The supplied blinded lot identifier is invalid."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-blinded-lots-{blindedLotId}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-blinded-lots-blindedlotid-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update blinded lot"
],
"summary":"v3.0",
"description":"Updates blinded lot with release depot to depot settings.",
"operationId":"updateBlindedLot_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"blindedLotId",
"in":"path",
"description":"ID of blinded lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/releaseForDepotToDepot"
},
"examples":{
"Update Blinded Lot Request":{
"description":"Update Blinded Lot Request",
"value":{
"blindedLotNumber":"Bld-Lt-AZ",
"shortName":"BlindedLot-01",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"manufacturingLotIds":[
"392DA9F053E94B9B9339AC7D0FA0D1DB"
],
"settingsByCountry":[
{
"countryIso":"US",
"doNotShip":50,
"doNotCount":10
}
],
"releaseForDepotToDepot":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Blinded Lot Response":{
"description":"Update Blinded Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Blinded lot not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Blinded Lot Not Found Response":{
"description":"Update Blinded Lot Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-404",
"errorMessage":"The blinded lot was not found.",
"details":{
"field":"blindedLotId",
"reason":"No blinded lot matched the supplied identifier."
}
}
}
}
}
}
}
},
"400":{
"description":"v3.0 The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Blinded Lot Bad Request Response":{
"description":"Update Blinded Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BLIND-400",
"errorMessage":"The blinded lot update request is invalid.",
"details":{
"field":"shortName",
"reason":"The blinded lot short name must be unique."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-blinded-lots-{blindedLotId}-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-blinded-lots-blindedlotid-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/settings/cohortlimits":{
"get":{
"tags":[
"Randomization and Supplies/Cohort APIs/Get cohort limits by study and mode"
],
"summary":"v3.0",
"description":"Retrieves cohort limits by study and mode. Rights: SubjectSettingRightsGet.",
"operationId":"getCohortLimits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortLimit"
}
},
"examples":{
"Get Cohort Limits Response":{
"description":"Get Cohort Limits Response",
"value":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"stratumId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"randomizationLimit":5,
"notificationLimit":5,
"enabled":true,
"forcedRandLimit":5
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Cohort Limits Server Error Response":{
"description":"Get Cohort Limits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"COHORT-500",
"errorMessage":"Unexpected error while retrieving cohort limits."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-settings-cohortlimits-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-settings-cohortlimits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Cohort APIs/Save cohort limits by study and mode"
],
"summary":"v3.0",
"description":"Saves cohort limits by study and mode. Rights: SubjectSettingRightsPost.",
"operationId":"setCohortLimits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"fromMode",
"in":"query",
"description":"From mode.",
"schema":{
"type":"string"
},
"example":"test"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/CohortLimitList"
},
"examples":{
"Set Cohort Limits Request":{
"description":"Set Cohort Limits Request",
"value":{
"cohortLimits":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"stratumId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"randomizationLimit":5,
"notificationLimit":5,
"enabled":true,
"forcedRandLimit":5
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortLimit"
}
},
"examples":{
"Set Cohort Limits Response":{
"description":"Set Cohort Limits Response",
"value":[
{
"cohortId":"B1B8327AFAA6412287106192AB5984EF",
"stratumId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"randomizationLimit":5,
"notificationLimit":5,
"enabled":true,
"forcedRandLimit":5
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Set Cohort Limits Server Error Response":{
"description":"Set Cohort Limits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"COHORT-500",
"errorMessage":"Unexpected error while saving cohort limits."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-settings-cohortlimits-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-settings-cohortlimits-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/events/codebreak/{eventId}":{
"get":{
"tags":[
"Randomization and Supplies/Event APIs/Get details about a Code Break event"
],
"summary":"v3.0",
"description":"Retrieves details about a Code Break event in the study. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeBreakEvent_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"eventId",
"in":"path",
"description":"ID of event.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"Code Break Event Response":{
"description":"Code Break Event Response",
"value":{
"eventId":"B1B8327AFAA6412287106192AB5984EF",
"actionType":"CODEBREAK",
"status":"COMPLETED"
}
}
}
}
}
},
"404":{
"description":"Study identifier does not match any study identifiers in Clinical One. OR Event not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Incorrect event type. Or No data found for the event.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-events-codebreak-{eventId}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-events-codebreak-eventid-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/kits/{sourceId}/export":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Export kit details for the inventory"
],
"summary":"v3.0",
"description":"Exports kit details for the inventory source as a CSV file. In this API, Block Number column is added to export in the file. Rights: DesignerKitListGet.",
"operationId":"export_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"sourceId",
"in":"path",
"description":"Source ID of the inventory.",
"required":true,
"schema":{
"type":"string"
},
"example":"INV-SRC-01"
}
],
"responses":{
"204":{
"description":"Successful operation",
"content":{
"*/*":{
"examples":{
"Export Inventory Kits Success (No Content)":{
"description":"Export is streamed as a file download; response has no body."
}
}
}
}
},
"404":{
"description":"No matching inventory source is available",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Inventory Export Not Found Response":{
"description":"Inventory Export Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Inventory Export Server Error Response":{
"description":"Inventory Export Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-kits-{sourceId}-export-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-kits-sourceid-export-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/inventorystatuses/allowed/{fromInventoryStatusId}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get allowed inventory statuses"
],
"summary":"v3.0",
"description":"Retrieves allowed inventory statuses. Rights: OrsInventoryGet.",
"operationId":"getAllowedInventoryStatuses_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"fromInventoryStatusId",
"in":"path",
"description":"ID of the initial inventory status in status transition.",
"required":true,
"schema":{
"type":"number"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Allowed Inventory Statuses Response":{
"description":"Get Allowed Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Allowed Inventory Statuses Server Error Response":{
"description":"Get Allowed Inventory Statuses Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-inventorystatuses-allowed-{fromInventoryStatusId}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-inventorystatuses-allowed-frominventorystatusid-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/inventorystatuses":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get inventory statuses"
],
"summary":"v3.0",
"description":"Retrieves statuses from an inventory. Rights: OrsInventoryGet.",
"operationId":"getInventoryStatuses_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Inventory Statuses Response":{
"description":"Get Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory Statuses Server Error Response":{
"description":"Get Inventory Statuses Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-inventorystatuses-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-inventorystatuses-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/inventory/kitDetails":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit details by kit number"
],
"summary":"v3.0",
"description":"Retrieves kit details by kit number. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitByKitNumber_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitInfoResponse"
},
"examples":{
"Get Kit By Kit Number Response":{
"description":"Get Kit By Kit Number Response",
"value":{
"kitDetails":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"manufacturingLotId":"LOT-001",
"blindedLotId":"BLDLOT-001",
"labelGroupId":"LABEL-001",
"inventoryStatus":"Available",
"manufacturingLotNumber":"ML-01",
"blindedLotNumber":"Bld-Lt-AZ",
"labelGroup":"LabelGroup-01",
"kitTypeSrcId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"materialId":"MAT-001",
"itemNumber":"ITEM-001",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"expirationDate":"2026-12-31T00:00:00Z",
"doNotCount":10,
"doNotShip":50,
"missingUnits":0,
"returnedUnits":0,
"verified":true,
"barcode":"1234567890"
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Not Found Response":{
"description":"Get Kit By Kit Number Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Bad Request Response":{
"description":"Get Kit By Kit Number Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Server Error Response":{
"description":"Get Kit By Kit Number Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-inventory-kitDetails-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-inventory-kitdetails-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/kitlists":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit list details"
],
"summary":"v3.0",
"description":"Retrieves generated or uploaded kit lists details in a study, for both pooled and non-pooled kits.
Rights: OrsInventoryGet.",
"operationId":"getKitListsDetails_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitListDetailsTOV3"
}
},
"examples":{
"Get Kit List Details Response":{
"description":"Get Kit List Details Response",
"value":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"KitList-01",
"description":"Example kit list.",
"statusId":1,
"versionStart":"2026-02-21T06:30:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"pooledKitList":false
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit List Details Server Error Response":{
"description":"Get Kit List Details Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-kitlists-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-kitlists-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/inventory/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary of serialized and non-serialized kits"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves a kit's summary. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitSummary_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitTypeSummaryResponse"
},
"examples":{
"Get Kit Summary Response":{
"description":"Get Kit Summary Response",
"value":{
"kitTypes":[
{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"description":"Example kit type.",
"packageTypeId":1,
"packageType":"Bottle",
"totalKitNumbers":100,
"kitsDispensed":5,
"kitsDamaged":1,
"kitsAvailable":94,
"kitsInTransit":0,
"kitsReturnedToSite":0,
"kitsPendingDestruction":0,
"kitsExpired":0
}
],
"minSequenceNumber":1,
"maxSequenceNumber":100,
"minKitNumber":1001,
"maxKitNumber":1100
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Not Found Response":{
"description":"Get Kit Summary Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Bad Request Response":{
"description":"Get Kit Summary Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Server Error Response":{
"description":"Get Kit Summary Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-inventory-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-inventory-kit-types-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/inventory/kits/audit":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Kit list details for each kit"
],
"summary":"v3.0",
"description":"Kit list details of each kit. In this API, blockNumber and kitNumberUTF are added to return block number and kit number in UTF-8. Rights: OrsInventoryGet.",
"operationId":"getKitsAudit_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"required":true,
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"required":true,
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
}
},
{
"name":"inventorySourceId",
"in":"query",
"description":"Source ID of the inventory.",
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"transactionId",
"in":"query",
"description":"String value for transaction ID of shipment.",
"schema":{
"type":"string"
},
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditRequestV1"
},
"examples":{
"Kits Audit Request":{
"description":"Kits Audit Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditResponse"
},
"examples":{
"Kits Audit Response":{
"description":"Kits Audit Response",
"value":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"transactionId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitNumberUTF":"KIT-1001",
"blockNumber":"BLK-01",
"kitNumber":1001,
"inventoryStatusId":1,
"operationType":"UPDATE",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"reason":"Audit",
"comment":"Updated kit status",
"subjectId":"11111111111111111111111111111111",
"visitId":"22222222222222222222222222222222",
"instanceNumber":1
}
}
}
}
}
},
"404":{
"description":"Invalid study ID OR Study not found OR Inventory Source ID not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Not Found Response":{
"description":"Kits Audit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Bad Request Response":{
"description":"Kits Audit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Server Error Response":{
"description":"Kits Audit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-inventory-kits-audit-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-inventory-kits-audit-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/inventory/kit-types/{kitTypeId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary by kit type ID"
],
"summary":"v3.0",
"description":"Retrieves kit summary by kit type ID with new Column : BlockNumbers, kitNumberUTF8. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitsByKitTypeId_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitTypeId",
"in":"path",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string"
},
"example":100
},
{
"name":"sortBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered. Default value is 'SEQUENCE_NUMBER'.",
"schema":{
"type":"string",
"default":"SEQUENCE_NUMBER"
},
"example":"SEQUENCE_NUMBER"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"schema":{
"type":"string"
},
"example":1001
},
{
"name":"blockNumber",
"in":"query",
"description":"Block number",
"schema":{
"type":"string"
},
"example":"BLK-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDetailsResponse"
},
"examples":{
"Get Kits By Kit Type ID Response":{
"description":"Get Kits By Kit Type ID Response",
"value":{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"minSequenceNumber":1,
"maxSequenceNumber":10,
"minKitNumber":1001,
"maxKitNumber":1010,
"totalResults":10,
"count":10,
"hasMore":false,
"limit":100,
"offset":0,
"links":[
{
"rel":"self",
"href":"https://example.com/v3.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/inventory/kit-types/9B83BFB48C5A41C59775E4D8D22D8B26/kits?offset=0&limit=100"
}
],
"kits":[
{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"inventoryStatus":"Available"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version or Kit type not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Not Found Response":{
"description":"Get Kits By Kit Type ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filtersOR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Bad Request Response":{
"description":"Get Kits By Kit Type ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Server Error Response":{
"description":"Get Kits By Kit Type ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-inventory-kit-types-{kitTypeId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-inventory-kit-types-kittypeid-kits-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/kits/{kitNumberUTF}/history":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history by KitNumberUTF"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves a kit's history by passing kitNumberUTF. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getSiteKitHistory_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitNumberUTF",
"in":"path",
"description":"Kit number in UTF-8 format.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-1001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
}
},
"examples":{
"Get Site Kit History Response":{
"description":"Get Site Kit History Response",
"value":[
{
"inventoryStatusId":5,
"inventoryStatus":"New",
"reason":"Audit",
"returnedUnits":10,
"missingUnits":5,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History Not Found Response":{
"description":"Get Site Kit History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History Server Error Response":{
"description":"Get Site Kit History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-kits-{kitNumberUTF}-history-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-kits-kitnumberutf-history-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/inventory/kits":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit attributes"
],
"summary":"v3.0",
"description":"Updates kit attributes. This version supports new filter BlockNumber and list of kit type IDs.
Rights: OrsInventoryPost and OrsUnblinded.",
"operationId":"updateKitAttributes_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitAttributesRequestV3"
},
"examples":{
"Update Kit Attributes Request":{
"description":"Update Kit Attributes Request",
"value":{
"reason":"Inventory update",
"inventoryStatusId":1,
"labelGroupId":"LABEL-001",
"location":"SITE-001",
"manufacturingLotId":"LOT-001",
"materialId":"MAT-001",
"itemNumber":"ITEM-001",
"updateMaterialId":true,
"updateItemNumber":true,
"kits":[
"B1B8327AFAA6412287106192AB5984EF"
],
"kitFilters":{
"location":"SITE-001",
"lotId":"LOT-001",
"kitStatus":"Available",
"kitRange":"1001-1010",
"labelGroupId":"LABEL-001",
"kitNumber":"1001",
"blockNumber":"BLK-01",
"kitTypeIds":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
}
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitsResponseV1"
},
"examples":{
"Update Kit Attributes Response":{
"description":"Update Kit Attributes Response",
"value":{
"noOfRowsUpdated":10
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Not Found Response":{
"description":"Update Kit Attributes Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Specify at least one kit attribute OR Reason is required OR Specify at least one filter. OR Either kits or kitFilters is required OR Invalid kit status OR Invalid kit range filter OR Invalid lot OR Invalid label group in kit filters OR Invalid kit type OR Invalid location OR No kits to update OR Update kits retrieved size exceeds maximum rows for update limit OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Bad Request Response":{
"description":"Update Kit Attributes Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Server Error Response":{
"description":"Update Kit Attributes Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitNumberUTF}/history":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit history for a site by kitNumberUTF"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves kit history, within a site, for a kit number given as kitNumberUTF. Rights: OrsInventoryGet and OrsBlinded.",
"operationId":"getSiteKitHistory_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitNumberUTF",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-1001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitStatusHistoryResponse"
},
"examples":{
"Get Site Kit History Response":{
"description":"Get Site Kit History Response",
"value":{
"inventoryStatusId":5,
"inventoryStatus":"New",
"reason":"Audit",
"returnedUnits":10,
"missingUnits":5,
"userName":"jane.doe",
"modifiedDate":"2026-02-21T08:43:01Z"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History Server Error Response":{
"description":"Get Site Kit History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid site and kit numberUTF combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History Not Found Response":{
"description":"Get Site Kit History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid study and invalid site",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kit History Bad Request Response":{
"description":"Get Site Kit History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitNumberUTF}-history-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-inventory-kits-kitnumberutf-history-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Use latest version instead. Retrieves kits for a site based on a given number range. Kit Range should be specified in the format as KIT_NUMBER:{From Kit number}:{To Kit number}. e.g. KIT_NUMBER:1:100.
Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getSiteKits_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1000-1100"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"required":true,
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":[
5,
10
]
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"11111111111111112000000000000000"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponse"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":false,
"minKitNumber":10,
"maxKitNumber":100,
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site"
}
],
"links":[
{
"rel":"self",
"href":"https://example.com/v3.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/sites/9B83BFB48C5A41C59775E4D8D22D8B26/inventory/kits?offset=0&limit=100"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Server Error Response":{
"description":"Get Site Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase OR invalid site ID OR invalid subject ID.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Not Found Response":{
"description":"Get Site Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Bad Request Response":{
"description":"Get Site Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update status for kits in a site"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Updates the status of a kit at a site. Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
},
"examples":{
"Update Kits Request":{
"description":"Update Kits Request",
"value":{
"inventoryStatusId":10,
"subjectId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Reconciled at site",
"returnedUnits":2,
"missingUnits":0,
"kits":[
"E39FF55A445543A38D513325664F0B2D",
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"kitsFilter":{
"kitRange":"KIT_NUMBER:10:100",
"searchString":"KIT",
"inventoryStatusIds":[
5,
10
],
"serialized":true
}
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Kits Response":{
"description":"Update Kits Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Server Error Response":{
"description":"Update Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Not Found Response":{
"description":"Update Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Bad Request Response":{
"description":"Update Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitId}":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit status by kit ID"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Updates a kit's status at a site by kit ID. Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitId",
"in":"path",
"description":"ID of the kit.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
},
"examples":{
"Update Kit By ID Request":{
"description":"Update Kit By ID Request",
"value":{
"inventoryStatusId":10,
"subjectId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Reconciled at site",
"returnedUnits":2,
"missingUnits":0,
"kits":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Kit By ID Response":{
"description":"Update Kit By ID Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit By ID Server Error Response":{
"description":"Update Kit By ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit By ID Not Found Response":{
"description":"Update Kit By ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit By ID Bad Request Response":{
"description":"Update Kit By ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitId}-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-inventory-kits-kitid-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/lots/manufacturing-lots":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get all manufacturing lots"
],
"summary":"v3.0",
"description":"Retrieves all manufacturing lots by study ID. Rights: LotManagementGet.",
"operationId":"getAllManufacturingLots_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":50
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ManufacturingLotTOV2"
}
},
"examples":{
"Get Manufacturing Lots Response":{
"description":"Get Manufacturing Lots Response",
"value":[
{
"lotId":"B1B8327AFAA6412287106192AB5984EF",
"manufacturingLotNumber":"ML-01",
"expirationDate":"2026-12-31T00:00:00Z",
"blindedLotId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"doNotCount":10,
"doNotShip":50,
"lotNumber":"LOT-001",
"versionStart":"2026-02-21T06:30:00Z",
"userId":"C36A3197-FDEE-433F-B554-7EE83DE99E4B",
"runNumber":"run number 01",
"operationType":"MODIFIED",
"objectVersionNumber":5,
"softwareVersionNumber":2,
"reason":"Audit",
"comment":"Updated manufacturing lot",
"inUse":true,
"versionEnd":"2026-02-22T06:30:00Z",
"blindedLotVersionStart":"2026-02-20T06:30:00Z"
}
]
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lots Forbidden Response":{
"description":"Get Manufacturing Lots Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view manufacturing lots.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lots Server Error Response":{
"description":"Get Manufacturing Lots Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while retrieving manufacturing lots.",
"details":{
"operation":"getAllManufacturingLots",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-manufacturing-lots-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-manufacturing-lots-get"
},
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Create manufacturing lot"
],
"summary":"v3.0",
"description":"Creates a manufacturing lot. Rights: LotManagementPost.",
"operationId":"createManufacturingLot_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotRequest"
},
"examples":{
"Create Manufacturing Lot Request":{
"description":"Create Manufacturing Lot Request",
"value":{
"manufacturingLotNumber":"ML-01",
"lotNumber":"LOT-001",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"quantity":100,
"materialId":"MAT-001",
"kitTypeSrcId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"updateMaterialId":true,
"updateKitTypeId":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create Manufacturing Lot Response":{
"description":"Create Manufacturing Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Manufacturing Lot Forbidden Response":{
"description":"Create Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to create manufacturing lots.",
"details":{
"right":"LotManagementPost",
"reason":"The current user does not have create access for manufacturing lots."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid expiration date. OR Manufacturing Lot Number already exists or Lot short name (lotNumber) already exists.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Manufacturing Lot Bad Request Response":{
"description":"Create Manufacturing Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"The manufacturing lot request is invalid.",
"details":{
"field":"materialId",
"reason":"materialId and kitTypeSrcId must match the selected kit type, and quantity must be greater than zero."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Manufacturing Lot Server Error Response":{
"description":"Create Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while creating the manufacturing lot.",
"details":{
"operation":"createManufacturingLot",
"reason":"The manufacturing lot could not be created."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-manufacturing-lots-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-manufacturing-lots-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/lots/manufacturing-lots/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get manufacturing lot by ID"
],
"summary":"v3.0",
"description":"Retrieves manufacturing lot by lot ID. Rights: LotManagementGet.",
"operationId":"getManufacturingLot_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManufacturingLotTOV2"
},
"examples":{
"Get Manufacturing Lot Response":{
"description":"Get Manufacturing Lot Response",
"value":{
"lotId":"B1B8327AFAA6412287106192AB5984EF",
"manufacturingLotNumber":"ML-01",
"expirationDate":"2026-12-31T00:00:00Z",
"blindedLotId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"doNotCount":10,
"doNotShip":50,
"lotNumber":"LOT-001",
"versionStart":"2026-02-21T06:30:00Z",
"userId":"C36A3197-FDEE-433F-B554-7EE83DE99E4B",
"runNumber":"run number 01",
"operationType":"MODIFIED",
"objectVersionNumber":5,
"softwareVersionNumber":2,
"reason":"Audit",
"comment":"Updated manufacturing lot",
"inUse":true,
"versionEnd":"2026-02-22T06:30:00Z",
"blindedLotVersionStart":"2026-02-20T06:30:00Z"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lot Forbidden Response":{
"description":"Get Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view the manufacturing lot.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lot Server Error Response":{
"description":"Get Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while retrieving the manufacturing lot.",
"details":{
"operation":"getManufacturingLot",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-manufacturing-lots-id-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update manufacturing lot by ID"
],
"summary":"v3.0",
"description":"Update manufacturing lot by a lot's ID. Rights: LotManagementPost.",
"operationId":"updateManufacturingLot_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LotRequest"
},
"examples":{
"Update Manufacturing Lot Request":{
"description":"Update Manufacturing Lot Request",
"value":{
"manufacturingLotNumber":"ML-01",
"lotNumber":"LOT-001",
"expirationDate":"2026-12-31",
"doNotShip":50,
"doNotCount":10,
"quantity":100,
"materialId":"MAT-001",
"kitTypeSrcId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"updateMaterialId":true,
"updateKitTypeId":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Manufacturing Lot Response":{
"description":"Update Manufacturing Lot Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Manufacturing Lot Forbidden Response":{
"description":"Update Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to update manufacturing lots.",
"details":{
"right":"LotManagementPost",
"reason":"The current user does not have update access for manufacturing lots."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid expiration date. OR Manufacturing Lot Number already exists or Lot short name (lotNumber) already exists.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Manufacturing Lot Bad Request Response":{
"description":"Update Manufacturing Lot Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"BAD_REQUEST",
"errorMessage":"The manufacturing lot update request is invalid.",
"details":{
"field":"kitTypeSrcId",
"reason":"kitTypeSrcId must be valid when updateKitTypeId is true, and expirationDate must use yyyy-MM-dd format."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Manufacturing Lot Server Error Response":{
"description":"Update Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while updating the manufacturing lot.",
"details":{
"operation":"updateManufacturingLot",
"reason":"The manufacturing lot could not be updated."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-lots-manufacturing-lots-id-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/kits/blindedchainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Blinded Chain of Custody report"
],
"summary":"v3.0",
"description":"Retrieves the Kit Blinded Chain of Custody report. Rights: UnblindedChainofCustodyReportPost.",
"operationId":"getBlindedChainOfCustodyReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Blinded Chain Of Custody Report Search Specs Request":{
"description":"Blinded Chain Of Custody Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"kitStatus",
"fieldType":"list",
"fieldValueList":[
"10"
]
},
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
},
{
"fieldName":"shipmentIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
},
{
"fieldName":"tempExcursionNumbers",
"fieldType":"list",
"fieldValueList":[
"TEMP-001"
]
},
{
"fieldName":"dataType",
"fieldType":"list",
"fieldValueList":[
"CSV"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-kits-blindedchainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-kits-blindedchainofcustody-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/kits/blindedInventory":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Inventory (Blinded) report"
],
"summary":"v3.0",
"description":"Retrieves the Kit Inventory (Blinded) report. Rights: BlindedInventoryReportPost.",
"operationId":"getBlindedInventoryReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"403":{
"description":"The study does not match any study in Clinical One.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-kits-blindedInventory-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-kits-blindedinventory-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/kits/chainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Chain of Custody Unblinded report"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves the Chain of Custody report, result can be filtered on the basis of Location, Date Range, Kit Type, Subject Number and Kit List. Rights: UnblindedChainofCustodyReportPost. Added Kit List in the filter.",
"operationId":"getChainOfCustodyReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"kitTypeIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
},
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
},
{
"fieldName":"kitListIds",
"fieldType":"list",
"fieldValueList":[
"D313327EF13845169A8ADADDA435431E"
]
},
{
"fieldName":"dataType",
"fieldType":"list",
"fieldValueList":[
"CSV"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-kits-chainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-kits-chainofcustody-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/projectedsupplies/countrycounts":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get projected supplies data for countries"
],
"summary":"v3.0",
"description":"Retrieves the projected supplies data for countries.",
"operationId":"getCountryCounts_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"sessionToken",
"in":"query",
"description":"Session token.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-projectedsupplies-countrycounts-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-projectedsupplies-countrycounts-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/doseholdsettings":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get dose hold settings report"
],
"summary":"v3.0",
"description":"Retrieves the dose hold settings report. Versioned to support auditing and includes the following new columns in the response: status, operation, LastModifiedDateTime.
Rights: SupplySettingRightsGet.",
"operationId":"getEnabledDoseHoldSettings_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-doseholdsettings-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-doseholdsettings-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/inventorysettings":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Study Inventory Settings report"
],
"summary":"v3.0",
"description":"Retrieves the Study Inventory Settings report. Rights: StudyDesignReportPost.",
"operationId":"getInventorySettingsReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-inventorysettings-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-inventorysettings-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/order-summary":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Order Summary report"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves the Order Summary report.",
"operationId":"getOrderSummarReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"receivedBy",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
},
{
"fieldName":"shippedBy",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"orderStatus",
"fieldType":"list",
"fieldValueList":[
"PENDING"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":" The result contains the following attributes \n\n 1. Shipped By SDF\n\n UUID of the site/depot which shipped the shipment. E.g. '41300000900000000000000000000001'\n\n 2. Received By SDF\n\n UUID of the site/depot which received the shipment. E.g. '41300000900000000000000000000001'\n\n 3. Received By SDF ID of Country\n\n UUID of the country of the site/depot which received the shipment. E.g. '41300000900000000000000000000001'\n\n 4. Shipment ID\n\n Name of shipment. E.g. 'Hyd125'\n\n 5. Shipment Type\n\n Type of shipment. E.g. 'Resupply'\n\n 6. Shipment Status\n\n Current status of the shipment. E.g. '4'\n\n 7. Date Requested\n\n Date on which the shipment was raised. E.g. '2020-01-20'\n\n 8. Date Received\n\n Date on which the shipment was received. null if the shipment is still not received\n\n 9. Days Outstanding\n\n Number of days until the shipment was received. If the shipment is still not received, this equals the number of days since the shipment was requested (current date - date requested).\n\n 9. Days Outstanding\n\n Number of days until the shipment was received. If the shipment is still not received, this equals the number of days since the shipment was requested (current date - date requested).\n\n 10. Date Cancelled/Marked Lost\n\n Date on which the shipment was canceled. null if not available (shipment not canceled)\n\n 11. Kit Count\n\n No. of kits in the shipment.\n\n 12. Kit Numbers in Shipment \n\n Kit numbers separated by `\\u7F`. E.g. \"300\\u7F400\"\n\n Use Character.toString((char) 0x7F) as the delimiter when concatenating multiple kits\n\n Use Character.toString((char) 0x7F) as the delimiter when concatenating multiple kits\n\n 13. Tracking Number\n\n Tracking number which is assigned to the shipment \n\nResponse Payload: \n\n{\n\n \"result\": {\n\n \"hasMore\": \"true\",\n\n \"totalResults\": 221,\n\n \"count\": 1,\n\n \"limit\": 1,\n\n \"offset\": 0,\n\n \"columns\": [\n\n \"Shipped By SDF\",\n\n \"Received By SDF\",\n\n \"Received By SDF ID for Country\",\n\n \"Shipment ID\",\n\n \"Shipment Type\",\n\n \"Shipment Status\",\n\n \"Date Requested\",\n\n \"Date Received\",\n\n \"Days Outstanding\",\n\n \"Date Cancelled/Marked Lost\",\n\n \"Kit Count\",\n\n \"Kit Numbers in Shipment\",\n\n \"Tracking Number\",\n\n \"Temperature Monitor Status\"\n\n ],\n\n \"data\": [\n\n [\n\n \"09CA38D0A01145A285B2086729B4453C\",\n\n \"EB0F5FE4B75E4652800B90BE21521733\",\n\n \"EB0F5FE4B75E4652800B90BE21521733\",\n\n \"depo161\",\n\n \"Manual\",\n\n \"Received\",\n\n \"04-Jan-2022\",\n\n \"04-Jan-2022\",\n\n \"0\",\n\n \"\",\n\n \"4\",\n\n \"100324704780\",\n\n \"\",\n\n \"Yes\"\n\n ]\n\n ]\n\n },\n\n \"status\": \"success\",\n\n \"errorData\": null\n\n}",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-order-summary-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-order-summary-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/unblindedrandreport":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Unblinded Randomization List report"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves the Randomization List report. Rights: UnblindedRandomizationReportPost.",
"operationId":"getRandReport_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"systemDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
},
{
"fieldName":"rndListId",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-unblindedrandreport-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-unblindedrandreport-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/recon":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Reconciliation report"
],
"summary":"v3.0",
"description":"Retrieves Kit Reconciliation report. Rights: ReconciliationReport.",
"operationId":"getReconReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Recon Report Search Specs Request":{
"description":"Recon Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
},
{
"fieldName":"kitStatus",
"fieldType":"list",
"fieldValueList":[
"10"
]
},
{
"fieldName":"shipmentIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-recon-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-recon-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/projectedsupplies/sitecounts":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get projected supplies data for sites"
],
"summary":"v3.0",
"description":"Retrieves the projected supplies data for sites.",
"operationId":"getSiteCounts_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"sessionToken",
"in":"query",
"description":"Session token.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"Report search parameters.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"Study not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-projectedsupplies-sitecounts-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-projectedsupplies-sitecounts-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/dispensations":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get the Subject Dispensation report"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves the Subject Dispensation report; Rights: SubjectDataReportPost. Site role: Blinded site user.",
"operationId":"getSubjectDispensationReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
},
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
},
{
"fieldName":"visitIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"403":{
"description":"403 Forbidden.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Validation error - Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-dispensations-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-dispensations-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/subjects":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Subject Data report"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves the Subject Data report. Rights: SubjectDataReportPost. This API is used in Subject Visit (Blinded) Report, Subject Events Report and CTMS Report.",
"operationId":"getSubjectsReport_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
},
{
"fieldName":"visitIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"eventTypes",
"fieldType":"list",
"fieldValueList":[
"RANDOMIZED"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-subjects-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-subjects-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/reports/kits/unblindedInventory":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Inventory (Unblinded) report"
],
"summary":"v3.0",
"description":"Retrieves the Kit Inventory (Unblinded) report. Rights: UnblindedInventoryReportPost.",
"operationId":"getUnBlindedInventoryReport_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Report Search Specs Request":{
"description":"Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"kitTypeIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
},
{
"fieldName":"lotIds",
"fieldType":"list",
"fieldValueList":[
"D313327EF13845169A8ADADDA435431E"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"403":{
"description":"The study does not match any study in Clinical One.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-reports-kits-unblindedInventory-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-reports-kits-unblindedinventory-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/resupplies":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Get all resupply groups"
],
"summary":"v3.0",
"description":"Retrieves all resupply groups created for a study.
Rights: SupplySettingRightsGet. Required sponsor roles are clinical supply manager and site manager.triggerWeeks and resupplyWeeks fields aren't needed for Min/Max strategies, so they're hidden when fetched.",
"operationId":"getResupplyGroups_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"resupplyTypeId",
"in":"query",
"description":"ID of resupply type.",
"required":true,
"schema":{
"type":"integer",
"format":"int32",
"enum":[
null
]
},
"example":1
},
{
"name":"type",
"in":"query",
"description":"Type of resupply.",
"schema":{
"type":"string",
"enum":[
"Site,Depot"
]
},
"example":"Site"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupResponseV2"
},
"examples":{
"Get Resupply Groups Response":{
"description":"Get Resupply Groups Response",
"value":{
"resupplyGroups":[
{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"resupplyName":"ResupplyGroup-01",
"resupplyTypeId":1,
"type":"Site",
"kitTypes":[
{
"id":"KITTYPE-01",
"kitTypeName":"KitType-01",
"description":"Example kit type.",
"packageTypeId":1,
"triggerWeeks":2,
"resupplyWeeks":4,
"minBuffer":10,
"maxBuffer":20,
"initialShippingUnits":10,
"manualConsignment":0
}
]
}
]
}
}
}
}
}
},
"404":{
"description":"Resupply not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Groups Not Found Response":{
"description":"Get Resupply Groups Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Groups Server Error Response":{
"description":"Get Resupply Groups Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-resupplies-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-resupplies-get"
},
"post":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Create a resupply group"
],
"summary":"v3.0",
"description":"Creates a resupply group for a study.
Rights: SupplySettingRightsPost
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"createResupplyGroup_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupRequestV3"
},
"examples":{
"Create Resupply Group Request":{
"description":"Create Resupply Group Request",
"value":{
"resupplyName":"ResupplyGroup-01",
"resupplyTypeId":1,
"type":"Site",
"ignoreSubjectsOnDoseHold":true,
"ignoreSubjectsOnSkipDispensingVisit":true,
"ignoreIfOutsideWindowBy":2,
"countRandomizedSubjects":true,
"groups":[
{
"id":"GROUP-01",
"name":"DynamicGroup-01",
"minRange":10,
"maxRange":20,
"kitTypes":[
{
"id":"9B83BFB48C5A41C59775E4D8D22D8B26",
"versionStart":"2026-02-21T06:30:00Z",
"triggerWeeks":2,
"resupplyWeeks":4,
"minBuffer":10,
"maxBuffer":20,
"initialShippingUnits":10,
"manualConsignment":0
}
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation"
},
"400":{
"description":"'Invalid resupply type', 'Duplicate resupply'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Resupply Group Bad Request Response":{
"description":"Create Resupply Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Create Resupply Group Server Error Response":{
"description":"Create Resupply Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-resupplies-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-resupplies-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/resupplies/{resupplyId}":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Get a resupply group by ID"
],
"summary":"v3.0",
"description":"Retrieves a resupply group by ID.
Rights: SupplySettingRightsGet. Required sponsor roles are clinical supply manager and site manager.",
"operationId":"getResupplyGroup_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"resupplyId",
"in":"path",
"description":"ID of resupply group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupResponseV2"
},
"examples":{
"Get Resupply Group Response":{
"description":"Get Resupply Group Response",
"value":{
"resupplyGroups":[
{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"resupplyName":"ResupplyGroup-01",
"resupplyTypeId":1,
"type":"Site"
}
]
}
}
}
}
}
},
"404":{
"description":"Resupply not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Group Not Found Response":{
"description":"Get Resupply Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Resupply Group Server Error Response":{
"description":"Get Resupply Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-resupplies-{resupplyId}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-resupplies-resupplyid-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Resupply Group Settings/Update a resupply by ID"
],
"summary":"v3.0",
"description":"Updates a resupply group by ID.
Rights: SupplySettingRightsPost
Required sponsor roles are clinical supply manager and site manager.",
"operationId":"updateResupplyGroup_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"resupplyId",
"in":"path",
"description":"ID of resupply group.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyGroupRequestV3"
},
"examples":{
"Update Resupply Group Request":{
"description":"Update Resupply Group Request",
"value":{
"resupplyId":"B1B8327AFAA6412287106192AB5984EF",
"resupplyName":"ResupplyGroup-01",
"resupplyTypeId":1,
"type":"Site",
"ignoreSubjectsOnDoseHold":true,
"ignoreSubjectsOnSkipDispensingVisit":true,
"ignoreIfOutsideWindowBy":2,
"countRandomizedSubjects":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation"
},
"404":{
"description":"'Resupply not found', 'Study identifier does not match any study identifiers in Clinical One.'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Resupply Group Not Found Response":{
"description":"Update Resupply Group Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"'Validation error, 'Invalid resupply type', 'Resupply already exists', 'Resupply contains duplicate IDs for kit types', 'Invalid kit type'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Resupply Group Bad Request Response":{
"description":"Update Resupply Group Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Resupply Group Server Error Response":{
"description":"Update Resupply Group Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-resupplies-{resupplyId}-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-resupplies-resupplyid-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/resupply/manual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create manual shipment in resupply strategy"
],
"summary":"v3.0",
"description":"Creates a manual shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"manual_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManualSupplyRequestV2"
},
"examples":{
"Create Manual Shipment Request":{
"description":"Create Manual Shipment Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E",
"siteId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kits":[
{
"kitTypeId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"lotId":"BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB",
"quantity":10
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ManualResupplyResponse"
}
},
"examples":{
"Create Manual Shipment Response":{
"description":"Create Manual Shipment Response",
"value":[
{
"orderId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"123",
"status":"PENDING"
}
]
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Manual Shipment Not Found Response":{
"description":"Create Manual Shipment Not Found Response",
"value":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"resource":"Site",
"reason":"The site or kit type referenced in the manual shipment request was not found."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Manual Shipment Server Error Response":{
"description":"Create Manual Shipment Server Error Response",
"value":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"createManualShipment",
"reason":"The manual shipment request could not be processed."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-resupply-manual-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-resupply-manual-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/resupply/resupply":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create a resupply strategy"
],
"summary":"v3.0",
"description":"Creates a resupply strategy for a study. Rights: OrsSupplyManagerPost. If the Resupply type is Predictive for any site and Trigger weeks and Resupply weeks aren't defined for any resupplykit type, a configuration exception is thrown. If Min/Max buffers aren't defined, the resupply strategy would use 0for the buffers. No exception is thrown.",
"operationId":"resupply_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResupplyRequestV1"
},
"examples":{
"Create Resupply Request":{
"description":"Create Resupply Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E"
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create Resupply Response":{
"description":"Create Resupply Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Resupply Not Found Response":{
"description":"Create Resupply Not Found Response",
"value":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"resource":"Study",
"reason":"No resupply configuration was found for the supplied study."
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Resupply Server Error Response":{
"description":"Create Resupply Server Error Response",
"value":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"createResupplyStrategy",
"reason":"The resupply request could not be submitted."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-resupply-resupply-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-resupply-resupply-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/{studyVersion}/randlist/generate":{
"post":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Create randomization list"
],
"summary":"v3.0",
"description":"Generates a randomization list in the study with sequence number; Rights: DesignerRandListPost.",
"operationId":"create_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"studyVersion",
"in":"path",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CommonGenerateRndListRequest"
},
"examples":{
"Generate Rand List Request":{
"description":"Generate Rand List Request",
"value":{
"randListDesignId":"B1B8327AFAA6412287106192AB5984EF",
"seed":12345
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/GenerateResponse"
},
"examples":{
"Generate Rand List Response":{
"description":"Generate Rand List Response",
"value":{
"listId":"9ECA4FA65076451DA7D47D59367D15A5",
"noOfRowsGenerated":5
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Generate Rand List Server Error Response":{
"description":"Generate Rand List Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Generate Rand List Not Found Response":{
"description":"Generate Rand List Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For algorithm not defined for the randomization design or randomization design not associated with a visit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Generate Rand List Bad Request Response":{
"description":"Generate Rand List Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-{studyVersion}-randlist-generate-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-studyversion-randlist-generate-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/randlists/{rndlistid}/randnumbers":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Numbers/Get randomization number"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves randomization number. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandNum_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"RNDLIST-01"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"blockedBy",
"in":"query",
"description":"ID of the entity which has blocked the randomization number.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"status",
"in":"query",
"description":"Status of the randomization number.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"cohortId",
"in":"query",
"description":"ID of the cohort.",
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandNumberResponse"
},
"examples":{
"Get Rand Numbers Response":{
"description":"Get Rand Numbers Response",
"value":{
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0,
"links":[
{
"rel":"self",
"href":"https://example.com/v3.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/randlists/RNDLIST-01/randnumbers?offset=0&limit=100"
}
],
"randNumbers":[
{
"randNumberId":"B1B8327AFAA6412287106192AB5984EF",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"2026-02-21T06:45:00Z",
"randNumber":1001,
"blockNumber":1,
"randStatusId":4,
"randStatusKey":"Assigned",
"treatmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"externalTreatmentId":"ARM-A",
"blockingParamName":"site",
"blockingParamId":"SITE-001",
"blockingParamValue":"Site1001",
"subjectId":"D313327EF13845169A8ADADDA435431E",
"subjectNumber":"S1001",
"statumId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"stratumName":"Male",
"cohortId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"cohortName":"Demo Cohort 1001",
"sequenceNumber":1001
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Numbers Server Error Response":{
"description":"Get Rand Numbers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version, or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Numbers Not Found Response":{
"description":"Get Rand Numbers Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-randlists-{rndlistid}-randnumbers-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-randlists-rndlistid-randnumbers-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/randlists":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves a randomization list. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlist_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO"
},
"examples":{
"Get Rand Lists Response":{
"description":"Get Rand Lists Response",
"value":{
"randListId":"B1B8327AFAA6412287106192AB5984EF",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"2026-02-21T06:45:00Z",
"name":"UPL_RL191_V1001",
"description":"Randomization list with demographic cohort",
"isStratified":"y",
"isBlocked":"y",
"isDynamic":"n",
"inUse":"y",
"blockedBy":"site",
"isCohortBased":"y",
"isMinimization":"n",
"lastAssctdRandDesignSrcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"lastAssctdStudyVersion":"1.0.1",
"useSequenceNumber":"y",
"firstAssctdRandDesignSrcId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"firstAssctdStudyVersion":"1.0.1",
"cohortType":"Adaptive"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Lists Server Error Response":{
"description":"Get Rand Lists Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Lists Not Found Response":{
"description":"Get Rand Lists Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-randlists-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-randlists-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/randlists/{rndlistid}":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list by ID"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves a randomization list by ID. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlistById_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"RNDLIST-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO"
},
"examples":{
"Get Rand List By ID Response":{
"description":"Get Rand List By ID Response",
"value":{
"randListId":"B1B8327AFAA6412287106192AB5984EF",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"2026-02-21T06:45:00Z",
"name":"UPL_RL191_V1001",
"description":"Randomization list with demographic cohort",
"isStratified":"y",
"isBlocked":"y",
"isDynamic":"n",
"inUse":"y",
"blockedBy":"site",
"isCohortBased":"y",
"isMinimization":"n",
"lastAssctdRandDesignSrcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"lastAssctdStudyVersion":"1.0.1",
"useSequenceNumber":"y",
"firstAssctdRandDesignSrcId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"firstAssctdStudyVersion":"1.0.1",
"cohortType":"Adaptive"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand List By ID Server Error Response":{
"description":"Get Rand List By ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand List By ID Not Found Response":{
"description":"Get Rand List By ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-randlists-{rndlistid}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-randlists-rndlistid-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/randlistdesigns":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Designs/Get randomization design list"
],
"summary":"v3.0",
"description":"Retrieves a randomization design list. Rights: OrsRandListGet, OrsUnblinded. Added new field: useSequenceNumber.",
"operationId":"getRandomizationListDesigns_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RndListDesignList"
}
},
"examples":{
"Get Randomization List Designs Response":{
"description":"Get Randomization List Designs Response",
"value":[
{
"randListId":"B1B8327AFAA6412287106192AB5984EF",
"randListName":"RandList-01",
"randomizationSeed":12345,
"useSequenceNumber":true,
"randDesigns":[
{
"randDesignId":"392DA9F053E94B9B9339AC7D0FA0D1DB",
"randDesignName":"Design-A"
}
]
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List Designs Server Error Response":{
"description":"Get Randomization List Designs Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Randomization List Designs Not Found Response":{
"description":"Get Randomization List Designs Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-randlistdesigns-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-randlistdesigns-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/shipments/{shipmentId}/eligible-kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get eligible kits"
],
"summary":"v3.0",
"description":"Searches for kits by kit type or shipment details. Rights: OrsInventoryGet, OrsUnblinded. Added additional field kitNumberUTF in the response",
"operationId":"getEligibleKits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentEligibleKitsResponseV2"
},
"examples":{
"Get Eligible Kits Response":{
"description":"Get Eligible Kits Response",
"value":{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"kits":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitNumber":5,
"sequenceNumber":5,
"kitTypeName":"Kit A",
"expirationDate":"2026-12-31T00:00:00Z",
"kitNumberUTF":"12345ab",
"srcId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0,
"links":[
{
"rel":"self",
"href":"https://example.com/v3.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/shipments/B1B8327AFAA6412287106192AB5984EF/eligible-kits?offset=0&limit=100"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Eligible Kits Server Error Response":{
"description":"Get Eligible Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Eligible Kits Not Found Response":{
"description":"Get Eligible Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-shipments-{shipmentId}-eligible-kits-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-shipments-shipmentid-eligible-kits-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves a kit's details by order. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getKits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":10001
},
{
"name":"orderBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered.",
"required":true,
"schema":{
"type":"string"
},
"example":"kitNumber"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentKitsResponseV3"
},
"examples":{
"Get Shipment Kits Response":{
"description":"Get Shipment Kits Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Kit type summary for shipment.",
"packageTypeId":1001,
"unitsPerKit":10,
"packageTypeKey":"BOTTLE",
"kits":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B",
"kitNumber":5,
"sequenceNumber":5,
"barcode":"KIT-000005",
"returnedUnits":0,
"missingUnits":0,
"depotReturnedUnits":0,
"inventoryStatusId":1,
"materialId":"MAT-001",
"itemNumber":"ITEM-001"
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Kits Server Error Response":{
"description":"Get Shipment Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Kits Not Found Response":{
"description":"Get Shipment Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-shipments-shipmentid-kits-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryDTOV3"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"89EE76326E984B548D594D592E5C7FC2",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Order not found.",
"details":{
"context":"shipment",
"reason":"No order matched the supplied shipment identifier."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Server Error Response":{
"description":"Get Order Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves a list of all orders in a study. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
}
},
{
"name":"limit",
"in":"query",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponseV3"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"89EE76326E984B548D594D592E5C7FC2",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Orders Server Error Response":{
"description":"Get Orders Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Orders Bad Request Response":{
"description":"Get Orders Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get shipment by shipment ID"
],
"summary":"v3.0",
"description":"Retrieves shipment by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipment_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentTOV2"
},
"examples":{
"Get Shipment Response":{
"description":"Get Shipment Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteName":"Site Houston",
"siteShortName":"st_hstn",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotName":"Depot Houston",
"depotShortName":"dpt_hstn",
"shipmentNumber":"SHIP-0001",
"statusId":1,
"createdDate":"2026-02-21T06:30:00Z",
"shipDate":"2026-02-21T06:45:00Z",
"trackingNumber":"12345",
"reportId":"D313327EF13845169A8ADADDA435431E",
"reconciliation":false,
"trackingNumberURL":"http://www.site.com",
"formInstanceId":"00d48a2a-7280-1a4e-e063-0100007f3af8"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Server Error Response":{
"description":"Get Shipment Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Not Found Response":{
"description":"Get Shipment Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipments_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV2"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"shipments":[
{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteName":"Site Houston",
"shipmentNumber":"SHIP-0001",
"statusId":1,
"createdDate":"2026-02-21T06:30:00Z"
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0,
"links":[
{
"rel":"self",
"href":"https://example.com/v3.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/shipments?offset=0&limit=100"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipments Server Error Response":{
"description":"Get Shipments Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipments Not Found Response":{
"description":"Get Shipments Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/shipment-statuses":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/List available order status values"
],
"summary":"v3.0",
"description":"Lists available order status values. Rights: OrsInventoryGet.",
"operationId":"getStatuses_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderStatus"
}
},
"examples":{
"Get Shipment Statuses Response":{
"description":"Get Shipment Statuses Response",
"value":[
{
"id":1,
"status":"PENDING"
}
]
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Order not found.",
"details":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"reason":"No order exists for the supplied shipment identifier."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Statuses Server Error Response":{
"description":"Get Shipment Statuses Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-shipment-statuses-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-shipment-statuses-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/shipments/{shipmentId}/received":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Mark kits as received"
],
"summary":"v3.0",
"description":"Marks kits as received in a study's inventory. Rights: OrsInventoryPost and DepotShipmentReceiptPost/OrsBlinded.",
"operationId":"markSiteOrDepotShipmentReceived_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedRequest"
},
"examples":{
"Mark Shipment Received Request":{
"description":"Mark Shipment Received Request",
"value":{
"updateKits":{
"KIT-0001":1,
"KIT-0002":2
},
"tempMonitorStatus":"yes"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentReceivedResponse"
},
"examples":{
"Mark Shipment Received Response":{
"description":"Mark Shipment Received Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"receivedDate":"2026-02-21T06:30:00Z",
"damagedCount":1,
"missingCount":0,
"preQuarantinedCount":0,
"availableCount":9
}
}
}
}
}
},
"400":{
"description":"'Invalid order status', 'Invalid kit'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Mark Shipment Received Bad Request Response":{
"description":"Mark Shipment Received Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid shipment ID', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Mark Shipment Received Not Found Response":{
"description":"Mark Shipment Received Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Mark Shipment Received Server Error Response":{
"description":"Mark Shipment Received Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-shipments-{shipmentId}-received-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-shipments-shipmentid-received-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get a shipment's details by ID for a site"
],
"summary":"v3.0",
"description":"Retrieves a shipment's details by ID for a site. This version includes additional attributes: versionStart and userId.
Rights: OrsSupplyManagerGet and OrsBlinded.",
"operationId":"getShipment_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserShipmentTOV3"
},
"examples":{
"Get Site Shipment Response":{
"description":"Get Site Shipment Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"siteId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"siteName":"Site 001",
"siteShortName":"SITE-001",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotName":"Depot 001",
"depotShortName":"DEPOT-001",
"statusId":1,
"shipmentNumber":"SHIP-0001",
"createdDate":"2026-02-21T06:30:00Z",
"shipDate":"2026-02-22T06:30:00Z",
"trackingNumber":"TRK-0001",
"trackingNumberURL":"https://carrier.example.com/TRK-0001",
"statusDate":"2026-02-22T06:30:00Z",
"damagedCount":0,
"missingCount":0,
"preQuarantinedCount":0,
"availableCount":12,
"inTransitCount":0,
"reportId":"D313327EF13845169A8ADADDA435431E",
"reconciliation":false,
"versionStart":"2026-02-21T06:30:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipment Not Found Response":{
"description":"Get Site Shipment Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipment Server Error Response":{
"description":"Get Site Shipment Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/sites/{siteId}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a site"
],
"summary":"v3.0",
"description":"Searches for shipments associated with a site by site ID. This version includes a new field in the response: formInstanceId.
Rights: OrsSupplyManagerGet and OrsBlinded.",
"operationId":"getShipments_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV3"
},
"examples":{
"Get Site Shipments Response":{
"description":"Get Site Shipments Response",
"value":{
"shipments":[
{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"shipmentNumber":"SHIP-0001",
"statusId":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0,
"links":[
{
"rel":"self",
"href":"https://example.com/v3.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/sites/9B83BFB48C5A41C59775E4D8D22D8B26/shipments?offset=0&limit=100"
}
]
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipments Not Found Response":{
"description":"Get Site Shipments Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipments Server Error Response":{
"description":"Get Site Shipments Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-shipments-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits or a specific kit for a shipment"
],
"summary":"v3.0",
"description":"Retrieves either all kits or a specific kit (if a kit number is provided) for a shipment. Rights: OrsSupplyManagerGet and OrsBlinded. Adds the kitNumberUTF field to the response.",
"operationId":"getSiteKits_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":10001
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteShipmentKitsTOV3"
},
"examples":{
"Get Site Shipment Kits Response":{
"description":"Get Site Shipment Kits Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0,
"links":[
{
"rel":"self",
"href":"https://example.com/v3.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/sites/9B83BFB48C5A41C59775E4D8D22D8B26/shipments/89EE76326E984B548D594D592E5C7FC2/kits?offset=0&limit=100"
}
],
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed"
}
]
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Shipment Kits Not Found Response":{
"description":"Get Site Shipment Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Shipment Kits Server Error Response":{
"description":"Get Site Shipment Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-kits-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/sites/{siteId}/resupply/manual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Initiate manual resupply to a site"
],
"summary":"v3.0",
"description":"Initiates manual resupply to a site. Rights: OrsSupplyManagerPost and OrsBlinded.",
"operationId":"siteInitiatedManualResupply_1",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteManualResupplyRequest"
},
"examples":{
"Site Initiated Manual Resupply Request":{
"description":"Site Initiated Manual Resupply Request",
"value":{
"jobInstanceId":"4FEBE3E166454E2687C6FAC306E7C86E",
"reason":"Some reason."
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Site Initiated Manual Resupply Response":{
"description":"Site Initiated Manual Resupply Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"400":{
"description":"Manual shipment is not allowed for this study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Site Initiated Manual Resupply Bad Request Response":{
"description":"Site Initiated Manual Resupply Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Site Initiated Manual Resupply Not Found Response":{
"description":"Site Initiated Manual Resupply Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Site Initiated Manual Resupply Server Error Response":{
"description":"Site Initiated Manual Resupply Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-sites-{siteId}-resupply-manual-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-sites-siteid-resupply-manual-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/supply/settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Get supply settings"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Use latest version instead. Retrieves supply settings by study ID.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsGet.",
"operationId":"getSupplySettings_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV3"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Supply Settings Server Error Response":{
"description":"Get Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-supply-settings-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-supply-settings-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Use latest version instead. Updates supply settings of a study by study ID.
Rights: SupplySettingRightsPost.
Required sponsor roles are: clinical supply manager and site manager.",
"operationId":"updateSupplySettings_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV3"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Not Found Response":{
"description":"Update Supply Settings Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Bad Request Response":{
"description":"Update Supply Settings Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Server Error Response":{
"description":"Update Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{subjectId}/titration-eligible":{
"get":{
"tags":[
"Randomization and Supplies/Titration APIs/Check if subject is eligible for titration"
],
"summary":"v3.0",
"description":"Checks if subject is eligible for titration. This is a new version of the API for returning additional attributes for titration kit label. Rights: OrsSubjectVisitGet.",
"operationId":"isTitrationAllowedForSubject_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"studyVersion",
"in":"query",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"11111111111111112000000000000000"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitKitTypeTO"
}
},
"examples":{
"Titration Eligible Response":{
"description":"Titration Eligible Response",
"value":[
{
"titrationId":"B1B8327AFAA6412287106192AB5984EF",
"status":"ALLOW",
"isUpAllowed":true,
"isDownAllowed":true,
"kitsDispensed":[
"B1B8327AFAA6412287106192AB5984EF",
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"titrationKitLabel":"Low Dose"
}
]
}
}
}
}
},
"400":{
"description":"For a subject who cannot be titrated as there are no titration kits dispensed to the subject earlier OR Subject cannot be titrated as no matching kits are defined with subject dispensations. ORInvalid subject OR Missing subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Titration Eligible Bad Request Response":{
"description":"Titration Eligible Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Visit not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Titration Eligible Not Found Response":{
"description":"Titration Eligible Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Titration Eligible Server Error Response":{
"description":"Titration Eligible Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{subjectId}-titration-eligible-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-subjectid-titration-eligible-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{subjectId}/allowed-doseholds":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get kits allowed for dose hold"
],
"summary":"v3.0",
"description":"Get kits allowed for dose hold in the current visit for a given subject, taking into account ADs. Rights: OrsSubjectVisitGet.",
"operationId":"getAllowedDoseHold_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"studyVersion",
"in":"query",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"required":true,
"schema":{
"type":"string"
},
"example":1
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"screeningDate",
"in":"query",
"description":"Screening date.",
"schema":{
"type":"string"
},
"example":"2026-03-01"
},
{
"name":"visitStartDate",
"in":"query",
"description":"Visit start date.",
"schema":{
"type":"string"
},
"example":"2026-03-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldKitsResponse"
},
"examples":{
"Allowed Dose Holds Response":{
"description":"Allowed Dose Holds Response",
"value":{
"status":"ALLOW_DOSE_HOLD",
"kitsAllowedForDoseHold":[
{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"trialSupplyType":"BOTTLE",
"deviceType":"ActivityWatch",
"blindedTItrationLabel":"Low dose",
"isTitration":true
}
],
"kitsNotAllowedForDoseHold":[
{
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"kitDescription":"Kit B",
"trialSupplyType":"BOTTLE",
"deviceType":"ActivityWatch",
"blindedTItrationLabel":"High dose",
"isTitration":false,
"reason":"DOSE_HOLD_VISIT_NOT_STARTED"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Allowed Dose Holds Bad Request Response":{
"description":"Allowed Dose Holds Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Allowed Dose Holds Server Error Response":{
"description":"Allowed Dose Holds Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{subjectId}-allowed-doseholds-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-subjectid-allowed-doseholds-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/codebreak":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get code break"
],
"summary":"v3.0",
"description":"Retrieves code break. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeBreak_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewRequest"
},
"examples":{
"Code Break Request":{
"description":"Code Break Request",
"value":{
"adverseEvent":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewResponse"
},
"examples":{
"Code Break Response":{
"description":"Code Break Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"description":"Randomized successfully",
"externalTreatmentId":"TA",
"randNumber":1001,
"randomizationDate":"2025-01-01T12:34:56Z",
"rndStatusId":5
}
],
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5,
"packageType":"BOTTLE"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found. Or site ID not found in site service",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Not Found Response":{
"description":"Code Break Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Bad Request Response":{
"description":"Code Break Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code Break Server Error Response":{
"description":"Code Break Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-codebreak-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-srcsubjectid-codebreak-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/codeview":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get code view"
],
"summary":"v3.0",
"description":"Retrieves code view. Rights: OrsSubjectVisitGet.",
"operationId":"getCodeView_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewRequest"
},
"examples":{
"Code View Request":{
"description":"Code View Request",
"value":{
"adverseEvent":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CodeViewResponse"
},
"examples":{
"Code View Response":{
"description":"Code View Response",
"value":{
"treatmentArms":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"description":"Randomized successfully",
"externalTreatmentId":"TA",
"randNumber":1001,
"randomizationDate":"2025-01-01T12:34:56Z",
"rndStatusId":5
}
],
"kitTypes":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5,
"packageType":"BOTTLE"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Not Found Response":{
"description":"Code View Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Bad Request Response":{
"description":"Code View Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Code View Server Error Response":{
"description":"Code View Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-codeview-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-srcsubjectid-codeview-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves dispensation history. Rights: OrsSubjectVisitGet.",
"operationId":"getDispensationHistory_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponseV2"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":10001,
"inventoryStatus":10,
"dispensationDate":"2026-03-01T08:30:00Z",
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"packageTypeId":5,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"lastModifiedDate":"2026-03-01T09:00:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"deviceType":"WearablePatch",
"deviceConnection":"DevicetoCloud",
"mHealthDeviceId":"MH-10001"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Not Found Response":{
"description":"Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Bad Request Response":{
"description":"Dispensation History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Server Error Response":{
"description":"Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{subjectId}/reuse-kits":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get reusable kits from a list of kit types"
],
"summary":"v3.0",
"description":"Retrieves previously dispensed kits, from a list of kit types passed in the request body, that can be reused in the current visit for a given subject. Support for unblinded pharmacist kits which are put on dose hold. UTF-8 format support for kitNumber. Rights: OrsSubjectVisitGet.",
"operationId":"getReusableDoseHoldKits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDoseHoldRequest"
},
"examples":{
"Reusable Kits Request":{
"description":"Reusable Kits Request",
"value":{
"studyVersion":"1.0.0.5",
"visitId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"instanceNumber":2,
"titrationOption":"up"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReusableKitsResponseV1"
},
"examples":{
"Reusable Kits Response":{
"description":"Reusable Kits Response",
"value":{
"status":"ALLOW",
"kits":[
{
"id":2,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"isDosingUnblinded":true,
"dose":5,
"measurement":"ml",
"frequency":"BID",
"kitDescription":"Kit A"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Bad Request Response":{
"description":"Reusable Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Server Error Response":{
"description":"Reusable Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{subjectId}-reuse-kits-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-subjectid-reuse-kits-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{subjectId}/doseheld":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get kits which are marked as dose hold"
],
"summary":"v3.0",
"description":"Get kits which are marked as dose hold for a given search criteria. Rights: OrsSubjectVisitGet.",
"operationId":"getSubjectVisitDoseHeldKits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"asofdate",
"in":"query",
"description":"Get data as of the given date",
"schema":{
"type":"string"
},
"example":"2026-03-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DoseHoldKitV3"
},
"examples":{
"Dose Held Kits Response":{
"description":"Dose Held Kits Response",
"value":{
"kitTypeSrcId":"D313327EF13845169A8ADADDA435431E",
"kitDescription":"Kit A",
"trialSupplyType":"BOTTLE",
"deviceType":"ActivityWatch",
"blindedTItrationLabel":"Low dose",
"isTitration":true,
"reason":"DOSE_HOLD_VISIT_NOT_STARTED"
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held Kits Bad Request Response":{
"description":"Dose Held Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dose Held Kits Server Error Response":{
"description":"Dose Held Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{subjectId}-doseheld-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-subjectid-doseheld-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/unblinded-disp-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded dispensation history for all subjects"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Retrieves unblinded dispensation history for all subjects within the study. Rights: OrsSubjectVisitGet. In this version pagination and these two fields were added : titrationOption, operationType",
"operationId":"getUnblindedAllDispHistory_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":100
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"audit",
"in":"query",
"description":"Value of audit parameter",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponse"
},
"examples":{
"Unblinded Dispensation History Response":{
"description":"Unblinded Dispensation History Response",
"value":{
"offset":0,
"limit":100,
"count":0,
"hasMore":false,
"totalResults":0,
"resultData":[
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Not Found Response":{
"description":"Unblinded Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid limit or offset values",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Bad Request Response":{
"description":"Unblinded Dispensation History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Server Error Response":{
"description":"Unblinded Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-unblinded-disp-history-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-unblinded-disp-history-get"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit by its visit ID. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"1001",
"kits":[
{
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":1001,
"kitTypeName":"Kit A"
}
],
"visitTimestamp":"2026-03-01T08:43:01Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":true,
"countOfKitTypesOnDoseHold":1,
"pendingKitQuantity":1,
"forcedRandomized":false
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or visit for subject does not exist",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Not Found Response":{
"description":"Get Visit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Bad Request Response":{
"description":"Get Visit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Server Error Response":{
"description":"Get Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Randomize a subject and/or dispense kits during a randomization or dispensation visit. Rights: OrsVisitManagementPost.",
"operationId":"visit_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequest"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"11111111111111111111111111111111",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:43:01"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"1001",
"kits":[
{
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":1001,
"kitTypeName":"Kit A"
}
],
"visitTimestamp":"2026-03-01T08:43:01Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":true,
"countOfKitTypesOnDoseHold":1,
"pendingKitQuantity":1,
"forcedRandomized":false
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Not Found Response":{
"description":"Visit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp. Or you must associate the randomization design with a visit before you can create/upload a randomization list for it Or the next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject Or subject can't be re-randomized before randomization. Or this operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Bad Request Response":{
"description":"Visit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported visit. Or subject already completed the visit. Or subject is randomized in error Or invalid treatment found for the subject. Or visit out of order. Or this operation is not allowed in the current subject status Or visit is outside visit window. Or visit is outside visit window and at least one kit is configured not to dispense outside visit window Or not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Server Error Response":{
"description":"Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v3.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/replacekits":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Replace a subject's kits"
],
"summary":"v3.0",
"description":"Replaces a subject's kits in the system, accepts Strings and Numbers. Rights: OrsVisitManagementPost.",
"operationId":"replaceSubjectKits_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsRequest"
},
"examples":{
"Replace Subject Kits Request":{
"description":"Replace Subject Kits Request",
"value":{
"kits":[
"5a"
],
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Some reason",
"reasonLabel":"kits are damaged"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsResponse"
},
"examples":{
"Replace Subject Kits Response":{
"description":"Replace Subject Kits Response",
"value":{
"replacedKits":[
{
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":1001,
"kitTypeName":"Kit A"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found. Or site ID not found in site service",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Not Found Response":{
"description":"Replace Subject Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or this operation is not allowed during the current subject statusOr invalid kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Bad Request Response":{
"description":"Replace Subject Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Subject is randomized in error. Or not enough inventory",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Server Error Response":{
"description":"Replace Subject Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v3.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-replacekits-post",
"x-filename-id":"ec-ors-svc-rest-v3.0-studies-studyid-mode-subjects-srcsubjectid-replacekits-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/inventorystatuses":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get inventory statuses"
],
"summary":"v4.0",
"description":"Retrieves statuses from an inventory. Rights: OrsInventoryGet.",
"operationId":"getInventoryStatuses_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"isLocalized",
"in":"query",
"description":"language",
"schema":{
"maximum":1,
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/InventoryStatus"
}
},
"examples":{
"Get Inventory Statuses Response":{
"description":"Get Inventory Statuses Response",
"value":[
{
"inventoryStatusId":1,
"inventoryStatus":"Available"
}
]
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Inventory Statuses Server Error Response":{
"description":"Get Inventory Statuses Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-inventorystatuses-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-inventorystatuses-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/inventory/kitDetails":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit details by kit number"
],
"summary":"v4.0",
"description":"Retrieves kit details by kit number. In this API, blockNumber and kitNumberUTF are added to return Block Number and Kit Number in UTF8. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitByKitNumber_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitInfoResponse"
},
"examples":{
"Get Kit By Kit Number Response":{
"description":"Get Kit By Kit Number Response",
"value":{
"kitDetails":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"manufacturingLotId":"LOT-001",
"blindedLotId":"BLDLOT-001",
"labelGroupId":"LABEL-001",
"inventoryStatus":"Available",
"manufacturingLotNumber":"ML-01",
"blindedLotNumber":"Bld-Lt-AZ",
"labelGroup":"LabelGroup-01",
"kitTypeSrcId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"materialId":"MAT-001",
"itemNumber":"ITEM-001",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"expirationDate":"2026-12-31T00:00:00Z",
"doNotCount":10,
"doNotShip":50,
"missingUnits":0,
"returnedUnits":0,
"verified":true,
"barcode":"1234567890"
}
}
}
}
}
}
},
"404":{
"description":"Invalid study ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Not Found Response":{
"description":"Get Kit By Kit Number Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Kit not found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Bad Request Response":{
"description":"Get Kit By Kit Number Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid kit number.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit By Kit Number Server Error Response":{
"description":"Get Kit By Kit Number Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-inventory-kitDetails-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-inventory-kitdetails-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/inventory/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary of serialized and non-serialized kits"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Retrieves a kit's summary. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitSummary_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTypeSummaryResponse"
}
},
"examples":{
"Get Kit Summary Response":{
"description":"Get Kit Summary Response",
"value":[
{
"kitTypes":[
{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"description":"Example kit type.",
"packageTypeId":1,
"packageType":"Bottle",
"totalKitNumbers":100,
"kitsDispensed":5,
"kitsDamaged":1,
"kitsAvailable":94,
"kitsInTransit":0,
"kitsReturnedToSite":0,
"kitsPendingDestruction":0,
"kitsExpired":0
}
]
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Not Found Response":{
"description":"Get Kit Summary Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location or Invalid kitNumber",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Bad Request Response":{
"description":"Get Kit Summary Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Server Error Response":{
"description":"Get Kit Summary Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-inventory-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-inventory-kit-types-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/inventory/kits/audit":{
"post":{
"tags":[
"Randomization and Supplies/Inventory APIs/Kit list details for each kit"
],
"summary":"v4.0",
"description":"Kit list details of each kit. In this API, tempExcursionNumber is added to return Temperature Excursion Number. Rights: OrsInventoryGet.",
"operationId":"getKitsAudit_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"required":true,
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"required":true,
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
},
{
"name":"inventorySourceId",
"in":"query",
"description":"Source ID of the inventory.",
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"transactionId",
"in":"query",
"description":"String value for transaction ID of shipment.",
"schema":{
"type":"string"
},
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditRequestV1"
},
"examples":{
"Kits Audit Request":{
"description":"Kits Audit Request",
"value":{
"kits":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitsAuditResponseV4"
},
"examples":{
"Kits Audit Response":{
"description":"Kits Audit Response",
"value":{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"transactionId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitNumberUTF":"KIT-1001",
"blockNumber":"BLK-01",
"kitNumber":1001,
"inventoryStatusId":1,
"operationType":"UPDATE",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"reason":"Audit",
"comment":"Updated kit status",
"subjectId":"11111111111111111111111111111111",
"visitId":"22222222222222222222222222222222",
"instanceNumber":1
}
}
}
}
}
},
"404":{
"description":"Invalid study ID OR Study not found OR Inventory Source ID not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Not Found Response":{
"description":"Kits Audit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Bad Request Response":{
"description":"Kits Audit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Kits Audit Server Error Response":{
"description":"Kits Audit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-inventory-kits-audit-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-inventory-kits-audit-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/inventory/kit-types/{kitTypeId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary by kit type ID"
],
"summary":"v4.0",
"description":"Retrieves kit summary by kit type ID with new Column : TempExcursionNumber. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitsByKitTypeId_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"kitTypeId",
"in":"path",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string"
},
"example":100
},
{
"name":"sortBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered. Default value is 'SEQUENCE_NUMBER'.",
"schema":{
"type":"string",
"default":"SEQUENCE_NUMBER"
},
"example":"SEQUENCE_NUMBER"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"schema":{
"type":"string"
},
"example":1001
},
{
"name":"blockNumber",
"in":"query",
"description":"Block number",
"schema":{
"type":"string"
},
"example":"BLK-01"
},
{
"name":"tempExcursionNumber",
"in":"query",
"description":"tempExcursionNumber",
"schema":{
"type":"string"
},
"example":"001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDetailsResponse"
},
"examples":{
"Get Kits By Kit Type ID Response":{
"description":"Get Kits By Kit Type ID Response",
"value":{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"minSequenceNumber":1,
"maxSequenceNumber":10,
"minKitNumber":1001,
"maxKitNumber":1010,
"totalResults":10,
"count":10,
"hasMore":false,
"limit":100,
"offset":0,
"links":[
{
"rel":"self",
"href":"https://example.com/v4.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/inventory/kit-types/9B83BFB48C5A41C59775E4D8D22D8B26/kits?offset=0&limit=100"
}
],
"kits":[
{
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":1001,
"sequenceNumber":1,
"inventoryStatusId":1,
"locationId":"SITE-001",
"inventoryStatus":"Available"
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version or Kit type not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Not Found Response":{
"description":"Get Kits By Kit Type ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filtersOR Invalid kit type OR Invalid Lot OR Invalid location",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Bad Request Response":{
"description":"Get Kits By Kit Type ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kits By Kit Type ID Server Error Response":{
"description":"Get Kits By Kit Type ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-inventory-kit-types-{kitTypeId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-inventory-kit-types-kittypeid-kits-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/inventory/kits":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit attributes"
],
"summary":"v4.0",
"description":"Updates kit attributes. Rights: OrsInventoryPost and OrsUnblinded. New filter tempExcursionNumber added.",
"operationId":"updateKitAttributes_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitAttributesRequestV4"
},
"examples":{
"Update Kit Attributes Request":{
"description":"Update Kit Attributes Request",
"value":{
"reason":"Inventory update",
"inventoryStatusId":1,
"labelGroupId":"LABEL-001",
"location":"SITE-001",
"manufacturingLotId":"LOT-001",
"materialId":"MAT-001",
"itemNumber":"ITEM-001",
"updateMaterialId":true,
"updateItemNumber":true,
"kits":[
"B1B8327AFAA6412287106192AB5984EF"
],
"kitFilters":{
"location":"SITE-001",
"lotId":"LOT-001",
"kitStatus":"Available",
"kitRange":"1001-1010",
"labelGroupId":"LABEL-001",
"kitNumber":"1001",
"blockNumber":"BLK-01",
"kitTypeIds":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
}
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateKitsResponse"
},
"examples":{
"Update Kit Attributes Response":{
"description":"Update Kit Attributes Response",
"value":{
"noOfRowsUpdated":10
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Not Found Response":{
"description":"Update Kit Attributes Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Specify at least one kit attribute OR Reason is required OR Specify at least one filter. OR Either kits or kitFilters is required OR Invalid kit status OR Invalid kit range filter OR Invalid lot OR Invalid label group in kit filters OR Invalid kit type OR Invalid location OR No kits to update OR Update kits retrieved size exceeds maximum rows for update limit OR Invalid inventory status transition",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Bad Request Response":{
"description":"Update Kit Attributes Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request payload.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit Attributes Server Error Response":{
"description":"Update Kit Attributes Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Use latest version instead. Retrieves kits for a site based on a given number range. Kit Range should be specified in the format as KIT_NUMBER:{From Kit number}:{To Kit number}. e.g. KIT_NUMBER:1:100.
Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getSiteKits_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT_NUMBER:10:100"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"required":true,
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":[
5,
10
]
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponse"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":false,
"minKitNumber":10,
"maxKitNumber":100,
"totalReturnedUnits":0,
"distinctInventoryStatusIds":[
10
],
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site"
}
],
"links":[
{
"rel":"self",
"href":"https://example.com/v4.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/sites/C36A3197FDEE433FB5547EE83DE99E4B/inventory/kits?offset=0&limit=100"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Server Error Response":{
"description":"Get Site Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID OR study still in design phase OR invalid site ID OR invalid subject ID.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Not Found Response":{
"description":"Get Site Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Kits Bad Request Response":{
"description":"Get Site Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update status for kits in a site"
],
"summary":"v4.0",
"description":"Updates the status of a kit at a site. Returns formInstanceId when user updates kits to pendingDestruction.
Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
},
"examples":{
"Update Kits Request":{
"description":"Update Kits Request",
"value":{
"inventoryStatusId":10,
"reason":"Reconciled at site",
"subjectId":"B1B8327AFAA6412287106192AB5984EF",
"returnedUnits":2,
"missingUnits":0,
"kits":[
"E39FF55A445543A38D513325664F0B2D",
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateSiteKitsResponseV2"
},
"examples":{
"Update Kits Response":{
"description":"Update Kits Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"tempExcursionNumber":"001",
"formInstanceId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Server Error Response":{
"description":"Update Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Not Found Response":{
"description":"Update Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kits Bad Request Response":{
"description":"Update Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-sites-siteid-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitId}":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit status by kit ID"
],
"summary":"v4.0",
"description":"Updates a kit's status at a site by kit ID. If the new status is quarantined it will generate a temperature excursion number.
Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"kitId",
"in":"path",
"description":"ID of the kit.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"E39FF55A445543A38D513325664F0B2D"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
},
"examples":{
"Update Kit By ID Request":{
"description":"Update Kit By ID Request",
"value":{
"inventoryStatusId":10,
"reason":"Reconciled at site",
"subjectId":"B1B8327AFAA6412287106192AB5984EF",
"returnedUnits":2,
"missingUnits":0
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Kit By ID Response":{
"description":"Update Kit By ID Response",
"value":{
"id":"E39FF55A445543A38D513325664F0B2D"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit By ID Server Error Response":{
"description":"Update Kit By ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit By ID Not Found Response":{
"description":"Update Kit By ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Kit By ID Bad Request Response":{
"description":"Update Kit By ID Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitId}-put",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-sites-siteid-inventory-kits-kitid-put"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/lots/manufacturing-lots":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get all manufacturing lots"
],
"summary":"v4.0",
"description":"Retrieves all manufacturing lots by study ID. Rights: LotManagementGet.",
"operationId":"getAllManufacturingLots_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records.",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ManufacturingLotCommon"
}
},
"examples":{
"Get Manufacturing Lots Response":{
"description":"Get Manufacturing Lots Response",
"value":[
{
"id":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"manufacturingLotNumber":"MLOT-4001",
"expirationDate":"2027-12-31T00:00:00Z",
"blindedLotId":"BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB",
"doNotCount":5,
"doNotShip":10,
"lotNumber":"LOT-4001",
"versionStart":"2026-03-01T08:00:00Z",
"userId":"C36A3197-FDEE-433F-B554-7EE83DE99E4B",
"runNumber":"run number 04",
"inUse":true,
"versionEnd":"2026-03-15T08:00:00Z",
"blindedLotVersionStart":"2026-02-25T08:00:00Z",
"operationType":"MODIFIED",
"objectVersionNumber":7,
"softwareVersionNumber":4,
"reason":"Material assignment updated",
"comment":"Manufacturing lot aligned to kit type",
"quantity":250,
"materialId":"MAT-4001",
"kitTypeSrcId":"30100000200000000000000000000005"
}
]
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lots Forbidden Response":{
"description":"Get Manufacturing Lots Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view manufacturing lots.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lots Server Error Response":{
"description":"Get Manufacturing Lots Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while retrieving manufacturing lots.",
"details":{
"operation":"getAllManufacturingLots",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-lots-manufacturing-lots-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-lots-manufacturing-lots-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/lots/manufacturing-lots/{id}":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get manufacturing lot by ID"
],
"summary":"v4.0",
"description":"Retrieves manufacturing lot by lot ID. Rights: LotManagementGet.",
"operationId":"getManufacturingLot_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"id",
"in":"path",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
},
{
"name":"includeDeleted",
"in":"query",
"description":"Include deleted records.",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManufacturingLotCommon"
},
"examples":{
"Get Manufacturing Lot Response":{
"description":"Get Manufacturing Lot Response",
"value":{
"id":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"manufacturingLotNumber":"MLOT-4001",
"expirationDate":"2027-12-31T00:00:00Z",
"blindedLotId":"BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB",
"doNotCount":5,
"doNotShip":10,
"lotNumber":"LOT-4001",
"versionStart":"2026-03-01T08:00:00Z",
"userId":"C36A3197-FDEE-433F-B554-7EE83DE99E4B",
"runNumber":"run number 04",
"inUse":true,
"versionEnd":"2026-03-15T08:00:00Z",
"blindedLotVersionStart":"2026-02-25T08:00:00Z",
"operationType":"MODIFIED",
"objectVersionNumber":7,
"softwareVersionNumber":4,
"reason":"Material assignment updated",
"comment":"Manufacturing lot aligned to kit type",
"quantity":250,
"materialId":"MAT-4001",
"kitTypeSrcId":"30100000200000000000000000000005"
}
}
}
}
}
},
"403":{
"description":"The study identifier does not match any study identifiers in Clinical One",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lot Forbidden Response":{
"description":"Get Manufacturing Lot Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to view the manufacturing lot.",
"details":{
"right":"LotManagementGet",
"reason":"The current user does not have access to manufacturing lot data."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Manufacturing Lot Server Error Response":{
"description":"Get Manufacturing Lot Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"Unexpected error while retrieving the manufacturing lot.",
"details":{
"operation":"getManufacturingLot",
"reason":"The manufacturing lot lookup failed."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-lots-manufacturing-lots-{id}-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-lots-manufacturing-lots-id-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/reports/kits/chainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Chain of Custody Unblinded report"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Retrieves the Chain of Custody report, result can be filtered on the basis of Location, Date Range, Kit Type, Subject Number and Kit List. Rights: UnblindedChainofCustodyReportPost. Added field: Return Site ID for a reconciliation shipment.",
"operationId":"getChainOfCustodyReport_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Chain Of Custody Report Search Specs Request":{
"description":"Chain Of Custody Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"kitTypeIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Chain Of Custody Report Response":{
"description":"Chain Of Custody Report Response",
"value":{
"status":"success",
"errorData":null,
"result":{
"columns":[
"Kit Number",
"Status"
],
"data":[
[
"10001",
"Available"
]
],
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":"false"
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Chain Of Custody Report Server Error Response":{
"description":"Chain Of Custody Report Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Chain Of Custody Report Bad Request Response":{
"description":"Chain Of Custody Report Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Chain Of Custody Report Not Found Response":{
"description":"Chain Of Custody Report Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-reports-kits-chainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-reports-kits-chainofcustody-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/reports/order-summary":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Order Summary report"
],
"summary":"v4.0",
"description":"Retrieves the Order Summary report.",
"operationId":"getOrderSummarReport_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Order Summary Report Search Specs Request":{
"description":"Order Summary Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":" The result contains the following attributes \n\n 1. Shipped By SDF\n\n UUID of the site/depot which shipped the shipment. E.g. '41300000900000000000000000000001'\n\n 2. Received By SDF\n\n UUID of the site/depot which received the shipment. E.g. '41300000900000000000000000000001'\n\n 3. Received By SDF ID of Country\n\n UUID of the country of the site/depot which received the shipment. E.g. '41300000900000000000000000000001'\n\n 4. Shipment ID\n\n Name of shipment. E.g. 'Hyd125'\n\n 5. Shipment Type\n\n Type of shipment. E.g. 'Resupply'\n\n 6. Shipment Status\n\n Current status of the shipment. E.g. '4'\n\n 7. Date Requested\n\n Date on which the shipment was raised. E.g. '2020-01-20'\n\n 8. Date Received\n\n Date on which the shipment was received. null if the shipment is still not received\n\n 9. Days Outstanding\n\n No. of days till the shipment was received. If the shipment is still not received, this would be equal to no. of days since the shipment was requested (current date - date requested).\n\n 10. Date Cancelled/Marked Lost\n\n Date on which the shipment was canceled. null if not available (shipment not canceled)\n\n 11. Kit Count\n\n No. of kits in the shipment.\n\n 12. Kit Numbers in Shipment \n\n Kit numbers separated by `\\u7F`. E.g. \"300\\u7F400\"\n\n Use Character.toString ((char) 0x7F) as delimiter while concatenating multiple kits\n\n 13. Tracking Number\n\n Tracking number which is assigned to the shipment \n\n 14. Received By User\n\n UUID of the user which received the shipment. E.g. '41300000900000000000000000000001'\n\nResponse Payload: \n\n{\n\n \"result\": {\n\n \"hasMore\": \"true\",\n\n \"totalResults\": 221,\n\n \"count\": 1,\n\n \"limit\": 1,\n\n \"offset\": 0,\n\n \"columns\": [\n\n \"Shipped By SDF\",\n\n \"Received By SDF\",\n\n \"Received By SDF ID for Country\",\n\n \"Shipment ID\",\n\n \"Shipment Type\",\n\n \"Shipment Status\",\n\n \"Date Requested\",\n\n \"Date Received\",\n\n \"Days Outstanding\",\n\n \"Date Cancelled/Marked Lost\",\n\n \"Kit Count\",\n\n \"Kit Numbers in Shipment\",\n\n \"Tracking Number\",\n\n \"Temperature Monitor Status\",\n\n \"Received By User\"\n\n ],\n\n \"data\": [\n\n [\n\n \"09CA38D0A01145A285B2086729B4453C\",\n\n \"EB0F5FE4B75E4652800B90BE21521733\",\n\n \"EB0F5FE4B75E4652800B90BE21521733\",\n\n \"depo161\",\n\n \"Manual\",\n\n \"Received\",\n\n \"04-Jan-2022\",\n\n \"04-Jan-2022\",\n\n \"0\",\n\n \"\",\n\n \"4\",\n\n \"100324704780\",\n\n \"\",\n\n \"Yes\",\n\n \"0000000000000000000000000000000B\"\n\n ]\n\n ]\n\n },\n\n \"status\": \"success\",\n\n \"errorData\": null\n\n}",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Order Summary Report Response":{
"description":"Order Summary Report Response",
"value":{
"status":"success",
"errorData":null,
"result":{
"columns":[
"Shipment Number",
"Status"
],
"data":[
[
"SHIP-0001",
"PENDING"
]
],
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":"false"
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Order Summary Report Server Error Response":{
"description":"Order Summary Report Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Order Summary Report Bad Request Response":{
"description":"Order Summary Report Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Order Summary Report Not Found Response":{
"description":"Order Summary Report Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-reports-order-summary-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-reports-order-summary-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/reports/unblindedrandreport":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Unblinded Randomization List report"
],
"summary":"v4.0",
"description":"Retrieves the Randomization List report. Rights: UnblindedRandomizationReportPost.",
"operationId":"getRandReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Randomization Report Search Specs Request":{
"description":"Randomization Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Randomization Report Response":{
"description":"Randomization Report Response",
"value":{
"status":"success",
"errorData":null,
"result":{
"columns":[
"Rand Number",
"Status"
],
"data":[
[
"10001",
"Assigned"
]
],
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":"false"
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Randomization Report Server Error Response":{
"description":"Randomization Report Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Randomization Report Bad Request Response":{
"description":"Randomization Report Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Randomization Report Not Found Response":{
"description":"Randomization Report Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-reports-unblindedrandreport-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-reports-unblindedrandreport-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/reports/recon":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Reconciliation report"
],
"summary":"v4.0",
"description":"Retrieves Kit Reconciliation report. Rights: ReconciliationReport.",
"operationId":"getReconReport_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"onlyCounts",
"in":"query",
"schema":{
"type":"boolean"
},
"example":false
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Reconciliation Report Search Specs Request":{
"description":"Reconciliation Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Reconciliation Report Response":{
"description":"Reconciliation Report Response",
"value":{
"status":"success",
"errorData":null,
"result":{
"columns":[
"Kit Number",
"Inventory Status"
],
"data":[
[
"10001",
"Available"
]
],
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":"false"
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reconciliation Report Server Error Response":{
"description":"Reconciliation Report Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reconciliation Report Bad Request Response":{
"description":"Reconciliation Report Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reconciliation Report Not Found Response":{
"description":"Reconciliation Report Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-reports-recon-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-reports-recon-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/reports/dispensations":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get the Subject Dispensation report"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Retrieves the Subject Dispensation report; Rights: SubjectDataReportPost. Site role: Blinded site user.",
"operationId":"getSubjectDispensationReport_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Subject Dispensation Report Search Specs Request":{
"description":"Subject Dispensation Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"9B83BFB48C5A41C59775E4D8D22D8B26"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Subject Dispensation Report Response":{
"description":"Subject Dispensation Report Response",
"value":{
"status":"success",
"errorData":null,
"result":{
"columns":[
"Subject",
"Visit"
],
"data":[
[
"S1001",
"Visit 1"
]
],
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":"false"
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Dispensation Report Server Error Response":{
"description":"Subject Dispensation Report Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"403":{
"description":"403 Forbidden.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Dispensation Report Forbidden Response":{
"description":"Subject Dispensation Report Forbidden Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to perform this operation.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Validation error - Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Dispensation Report Bad Request Response":{
"description":"Subject Dispensation Report Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subject Dispensation Report Not Found Response":{
"description":"Subject Dispensation Report Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-reports-dispensations-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-reports-dispensations-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/reports/subjects":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Subject Data report"
],
"summary":"v4.0",
"description":"Retrieves the Subject Data report. Rights: SubjectDataReportPost. This API is used in Subject Visit (Blinded) Report, Subject Events Report and CTMS Report.",
"operationId":"getSubjectsReport_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"sessionToken",
"in":"query",
"description":"Session token.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Subjects Report Search Specs Request":{
"description":"Subjects Report Search Specs Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Subjects Report Response":{
"description":"Subjects Report Response",
"value":{
"status":"success",
"errorData":null,
"result":{
"columns":[
"Subject",
"Event Type"
],
"data":[
[
"S1001",
"DISPENSE"
]
],
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":"false"
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subjects Report Server Error Response":{
"description":"Subjects Report Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subjects Report Bad Request Response":{
"description":"Subjects Report Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Subjects Report Not Found Response":{
"description":"Subjects Report Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-reports-subjects-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-reports-subjects-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/resupply/manual":{
"post":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Create manual shipment in resupply strategy"
],
"summary":"v4.0",
"description":"Creates a manual shipment as part of a study's predictive resupply group. Rights: OrsSupplyManagerPost.",
"operationId":"manual_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ManualSupplyRequestV2"
},
"examples":{
"Create Manual Shipment Request":{
"description":"Create Manual Shipment Request",
"value":{
"studyId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"jobInstanceId":"JOB-001",
"siteId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kits":[
{
"kitTypeId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"lotId":"BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB",
"quantity":10
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Create Manual Shipment Response":{
"description":"Create Manual Shipment Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Manual Shipment Not Found Response":{
"description":"Create Manual Shipment Not Found Response",
"value":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"examples":{
"Create Manual Shipment Server Error Response":{
"description":"Create Manual Shipment Server Error Response",
"value":{
"errorCode":"INTERNAL_SERVER_ERROR",
"errorMessage":"An unexpected error occurred."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-resupply-manual-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-resupply-manual-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/randlists/{rndlistid}/randnumbers":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Numbers/Get randomization number"
],
"summary":"v4.0",
"description":"Retrieves randomization number. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandNum_2",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"ARM-A"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"blockedBy",
"in":"query",
"description":"ID of the entity which has blocked the randomization number.",
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"status",
"in":"query",
"description":"Status of the randomization number.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"cohortId",
"in":"query",
"description":"ID of the cohort.",
"schema":{
"type":"string"
},
"example":"COH-01"
},
{
"name":"groupId",
"in":"query",
"description":"ID of the group in a stratum.",
"schema":{
"type":"string"
},
"example":"GRP-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandNumberResponse"
},
"examples":{
"Get Rand Numbers Response":{
"description":"Get Rand Numbers Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"randNumbers":[
{
"randNumberId":"D313327EF13845169A8ADADDA435431E",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"2026-02-21T06:45:00Z",
"randNumber":10001,
"blockNumber":1,
"randStatusId":1,
"externalTreatmentId":"ARM-A",
"blockingParamName":"site",
"blockingParamId":"SITE-001",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"cohortId":"COH-01",
"sequenceNumber":1001
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Numbers Server Error Response":{
"description":"Get Rand Numbers Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version, or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Numbers Not Found Response":{
"description":"Get Rand Numbers Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-randlists-{rndlistid}-randnumbers-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-randlists-rndlistid-randnumbers-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/randlists":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Retrieves a randomization list. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlist_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO"
},
"examples":{
"Get Rand Lists Response":{
"description":"Get Rand Lists Response",
"value":{
"randListId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"2026-02-21T06:45:00Z",
"name":"UPL_RL191_V1001",
"description":"Randomization list with demographic cohort",
"isStratified":"n",
"isBlocked":"y",
"isDynamic":"n",
"inUse":"y",
"blockedBy":"site",
"isCohortBased":"y",
"firstAssctdRandDesignSrcId":"B1B8327AFAA6412287106192AB5984EF",
"firstAssctdStudyVersion":"1.0.1",
"isMinimization":"n",
"lastAssctdRandDesignSrcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"lastAssctdStudyVersion":"1.0.2"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Lists Server Error Response":{
"description":"Get Rand Lists Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand Lists Not Found Response":{
"description":"Get Rand Lists Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-randlists-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-randlists-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/randlists/{rndlistid}":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list by ID"
],
"summary":"v4.0",
"description":"Retrieves a randomization list by ID. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlistById_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO"
},
"examples":{
"Get Rand List By ID Response":{
"description":"Get Rand List By ID Response",
"value":{
"randListId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"2026-02-21T06:45:00Z",
"name":"UPL_RL191_V1001",
"description":"Randomization list with demographic cohort",
"isStratified":"n",
"isBlocked":"y",
"isDynamic":"n",
"inUse":"y",
"blockedBy":"site",
"isCohortBased":"y",
"firstAssctdRandDesignSrcId":"B1B8327AFAA6412287106192AB5984EF",
"firstAssctdStudyVersion":"1.0.1",
"isMinimization":"n",
"lastAssctdRandDesignSrcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"lastAssctdStudyVersion":"1.0.2"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand List By ID Server Error Response":{
"description":"Get Rand List By ID Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Rand List By ID Not Found Response":{
"description":"Get Rand List By ID Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-randlists-{rndlistid}-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-randlists-rndlistid-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/shipments/{shipmentId}/eligible-kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get eligible kits"
],
"summary":"v4.0",
"description":"Searches for kits by kit type or shipment details. Rights: OrsInventoryGet, OrsUnblinded. Added additional field kitNumberUTF in the response",
"operationId":"getEligibleKits_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentEligibleKitsResponse"
},
"examples":{
"Get Eligible Kits Response":{
"description":"Get Eligible Kits Response",
"value":{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"kits":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitNumber":5,
"sequenceNumber":5,
"kitTypeName":"Kit A",
"expirationDate":"2026-12-31T00:00:00Z",
"kitNumberUTF":"12345ab",
"srcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"lotId":"BBBBBBBBBBBBBBBBBBBBBBBBBBBBBBBB",
"lotNumber":"LOT-001",
"quantity":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Eligible Kits Server Error Response":{
"description":"Get Eligible Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Eligible Kits Not Found Response":{
"description":"Get Eligible Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-shipments-{shipmentId}-eligible-kits-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-shipments-shipmentid-eligible-kits-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits"
],
"summary":"v4.0",
"description":"Retrieves a kit's details by order. Rights: OrsInventoryGet, OrsUnblinded. Added new field: kitNumberUTF to the response.",
"operationId":"getKits_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":10001
},
{
"name":"orderBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered.",
"required":true,
"schema":{
"type":"string"
},
"example":"kitNumber"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentKitsResponseV4"
},
"examples":{
"Get Shipment Kits Response":{
"description":"Get Shipment Kits Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"kitTypes":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitTypeName":"Kit A",
"description":"Kit type summary for shipment.",
"packageTypeId":1001,
"unitsPerKit":10,
"packageTypeKey":"BOTTLE",
"kits":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B",
"kitNumber":5,
"sequenceNumber":5,
"barcode":"KIT-000005",
"returnedUnits":0,
"missingUnits":0,
"depotReturnedUnits":0,
"inventoryStatusId":1,
"materialId":"MAT-001",
"itemNumber":"ITEM-001"
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Kits Server Error Response":{
"description":"Get Shipment Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Kits Not Found Response":{
"description":"Get Shipment Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-shipments-shipmentid-kits-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. In this API, blockNumber and kitNumberUTF added to return block number and kit number in UTF-8. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryDTO"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"89EE76326E984B548D594D592E5C7FC2",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Order not found.",
"details":{
"context":"shipment",
"reason":"No order matched the supplied shipment identifier."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Server Error Response":{
"description":"Get Order Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Retrieves a list of all orders in a study. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponse"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"89EE76326E984B548D594D592E5C7FC2",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Orders Server Error Response":{
"description":"Get Orders Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Orders Bad Request Response":{
"description":"Get Orders Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get shipment by shipment ID"
],
"summary":"v4.0",
"description":"Retrieves shipment containing source and destination locations by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipment_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentTOV2"
},
"examples":{
"Get Shipment Response":{
"description":"Get Shipment Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"shipmentNumber":"SHIP-0001",
"statusId":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Server Error Response":{
"description":"Get Shipment Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Not Found Response":{
"description":"Get Shipment Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipments_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV2"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"shipments":[
{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"shipmentNumber":"SHIP-0001",
"statusId":1,
"createdDate":"2026-02-21T06:30:00Z"
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipments Server Error Response":{
"description":"Get Shipments Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipments Not Found Response":{
"description":"Get Shipments Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/shipment-statuses":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/List available order status values"
],
"summary":"v4.0",
"description":"Lists available order status values. Rights: OrsInventoryGet.",
"operationId":"getStatuses_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/OrderStatus"
}
},
"examples":{
"Get Shipment Statuses Response":{
"description":"Get Shipment Statuses Response",
"value":[
{
"id":1,
"status":"PENDING"
}
]
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Order not found.",
"details":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"reason":"No order exists for the supplied shipment identifier."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Shipment Statuses Server Error Response":{
"description":"Get Shipment Statuses Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"shipment",
"reason":"Review the error code and message for the failed shipment request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-shipment-statuses-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-shipment-statuses-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get a shipment's details by ID for a site"
],
"summary":"v4.0",
"description":"Retrieves a shipment's details by ID for a site. Rights: OrsSupplyManagerGet and OrsBlinded. Added additional attributes: quarantinedCount.",
"operationId":"getShipment_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserShipmentTO"
},
"examples":{
"Get Site Shipment Response":{
"description":"Get Site Shipment Response",
"value":{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"123",
"status":"INTRANSIT"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipment Not Found Response":{
"description":"Get Site Shipment Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Shipment not found.",
"details":{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipment Server Error Response":{
"description":"Get Site Shipment Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"getShipment",
"shipmentId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/sites/{siteId}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a site"
],
"summary":"v4.0",
"description":"Searches for shipments associated with a site by site ID. This version includes a new fields in the response: shipmentRegisteredDate, shipmentReceivedDate.
Rights: OrsSupplyManagerGet and OrsBlinded.",
"operationId":"getShipments_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
}
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
}
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
}
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
}
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
}
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV4"
},
"examples":{
"Get Site Shipments Response":{
"description":"Get Site Shipments Response",
"value":{
"shipments":[
{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteName":"Houston Research Center",
"statusId":1,
"shipmentNumber":"SHIP-0001",
"createdDate":"2026-02-20T08:30:00Z",
"shipDate":"2026-02-21T06:45:00Z",
"trackingNumber":"1Z9999999999999999",
"reconciliation":false,
"trackingNumberURL":"http://www.site.com/tracking/1Z9999999999999999",
"formInstanceId":"00D48A2A-7280-1A4E-E063-0100007F3AF8",
"shipmentRegisteredDate":"2026-02-20T08:30:00Z",
"shipmentReceivedDate":"2026-02-24T10:15:00Z"
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipments Not Found Response":{
"description":"Get Site Shipments Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No shipments were found for the supplied criteria.",
"details":{
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"searchString":"SHIP"
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Site Shipments Server Error Response":{
"description":"Get Site Shipments Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"getShipments",
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B"
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-sites-siteid-shipments-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/sites/{siteId}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits or a specific kit for a shipment"
],
"summary":"v4.0",
"description":"Retrieves either all kits or a specific kit (if a kit number is provided) for a shipment. Rights: OrsSupplyManagerGet and OrsBlinded. Adds support for non-serialized kits.",
"operationId":"getSiteKits_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-1001"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteShipmentKitsTO"
},
"examples":{
"Get Site Shipment Kits Response":{
"description":"Get Site Shipment Kits Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"totalResults":1,
"hasMore":false,
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"kits":[
{
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":1001,
"inventoryStatusId":10,
"barcode":"KIT-1001",
"lotNumber":"Manufacturing lot 1",
"lotId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"quantity":1
}
],
"links":[
{
"rel":"self",
"href":"https://example.com/v4.0/studies/1BC29B36F5D64B1B95F4BDBBCEA481BE/test/sites/C36A3197FDEE433FB5547EE83DE99E4B/shipments/B1B8327AFAA6412287106192AB5984EF/kits?offset=0&limit=100"
}
]
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in Draft (design phase)', 'Invalid site ID', 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Shipment Kits Not Found Response":{
"description":"Get Site Shipment Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":"KIT-1001"
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Site Shipment Kits Server Error Response":{
"description":"Get Site Shipment Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"operation":"getSiteKits",
"shipmentId":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-sites-{siteId}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-sites-siteid-shipments-shipmentid-kits-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/supply/settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Get supply settings"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Retrieves a study's supply settings by study ID. This version includes new field confirmDispensation in Response.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsGet.",
"operationId":"getSupplySettings_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV4"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Supply Settings Server Error Response":{
"description":"Get Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-supply-settings-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-supply-settings-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Updates a study's supply settings by study ID. This version includes new field confirmDispensation in Response.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV4"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":true,
"allowSingleKitQuarantine":true,
"allowManualConsignments":true,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":2,
"shipmentPrefixType":"DEPOTID",
"customShipmentIdPrefix":"SomePrefix",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Not Found Response":{
"description":"Update Supply Settings Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Bad Request Response":{
"description":"Update Supply Settings Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Update Supply Settings Server Error Response":{
"description":"Update Supply Settings Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Use latest version instead. Retrieves dispensation history by study ID. Rights: OrsSubjectVisitGet.",
"operationId":"getDispensationHistory_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponseV4"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":10001,
"inventoryStatus":10,
"dispensationDate":"2026-03-01T08:30:00Z",
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"packageTypeId":5,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"C36A3197FDEE433FB5547EE83DE99E4B",
"lastModifiedDate":"2026-03-01T09:00:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"deviceType":"WearablePatch",
"deviceConnection":"DevicetoCloud",
"mHealthDeviceId":"MH-10001"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Not Found Response":{
"description":"Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Bad Request Response":{
"description":"Dispensation History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Dispensation History Server Error Response":{
"description":"Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/subjects/{subjectId}/reuse-kits":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Get reusable kits from a list of kit types"
],
"summary":"v4.0",
"description":"Retrieves previously dispensed kits, from a list of kit types passed in the request body, that can be reused in the current visit for a given subject. Support for unblinded pharmacist kits which are put on dose hold. UTF-8 format support for kitNumber. Rights: OrsSubjectVisitGet.",
"operationId":"getReusableDoseHoldKits_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"subjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDoseHoldRequest"
},
"examples":{
"Reusable Kits Request":{
"description":"Reusable Kits Request",
"value":{
"studyVersion":"1.0.0.5",
"visitId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"instanceNumber":1,
"titrationOption":"up",
"kitTypesForDoseHold":[
{
"kitTypeSrcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"trialSupplyType":"BOTTLE",
"deviceType":"Spirometer",
"isTitration":true
}
],
"screeningDate":"2026-02-21T06:30:00",
"visitStartDate":"2026-02-21T06:45:00"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReusableKitsResponseV1"
},
"examples":{
"Reusable Kits Response":{
"description":"Reusable Kits Response",
"value":{
"status":"ALLOW",
"kits":[
{
"id":2,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"isDosingUnblinded":true,
"dose":5,
"measurement":"ml",
"frequency":"BID",
"kitDescription":"Kit A"
}
]
}
}
}
}
}
},
"400":{
"description":"Invalid subject OR Scheduled visit with instance number OR Unscheduled visit with no instance number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Bad Request Response":{
"description":"Reusable Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Reusable Kits Server Error Response":{
"description":"Reusable Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-subjects-{subjectId}-reuse-kits-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-subjects-subjectid-reuse-kits-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/unblinded-disp-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded dispensation history for all subjects"
],
"summary":"v4.0",
"description":"Retrieves unblinded dispensation history for all subjects within the study. In this version pagination and these two fields were added : - titrationOption
- operationType
Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedAllDispHistory_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":100
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"audit",
"in":"query",
"description":"Value of audit parameter",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponse"
},
"examples":{
"Unblinded Dispensation History Response":{
"description":"Unblinded Dispensation History Response",
"value":{
"offset":0,
"limit":100,
"count":0,
"hasMore":false,
"totalResults":0,
"resultData":[
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Not Found Response":{
"description":"Unblinded Dispensation History Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid limit or offset values",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Bad Request Response":{
"description":"Unblinded Dispensation History Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Unblinded Dispensation History Server Error Response":{
"description":"Unblinded Dispensation History Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-unblinded-disp-history-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-unblinded-disp-history-get"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Use latest version instead. Retrieves visit by visit ID. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"groupingNumber":1,
"kitNumberUTF":"A-1",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"LOT20240605A",
"dosingInstruction":"Take one capsule daily"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":false,
"countOfKitTypesOnDoseHold":0,
"pendingKitQuantity":1,
"forcedRandomized":false
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Not Found Response":{
"description":"Get Visit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Bad Request Response":{
"description":"Get Visit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Visit Server Error Response":{
"description":"Get Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Use latest version instead. Randomize a subject and/or dispense kits during a randomization or dispensation visit. Rights: OrsVisitManagementPost.",
"operationId":"visit_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV4"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"visitId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"subjectId":"11111111111111111111111111111111",
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:30:00",
"parameters":[
{
"name":"WEIGHT",
"value":"70"
}
],
"titrationOption":"up",
"userConfirmationTaken":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"groupingNumber":1,
"kitNumberUTF":"A-1",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"LOT20240605A",
"dosingInstruction":"Take one capsule daily"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A",
"needsToVisitPharmacist":false,
"countOfKitTypesOnDoseHold":0,
"pendingKitQuantity":1,
"forcedRandomized":false
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Not Found Response":{
"description":"Visit Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Bad Request Response":{
"description":"Visit Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Visit Server Error Response":{
"description":"Visit Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v4.0/studies/{studyId}/{mode}/subjects/{srcSubjectId}/replacekits":{
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Replace a subject's kits"
],
"summary":"v4.0",
"description":"Replaces a subject's kits in the system, accepts Strings and Numbers. Allows non-serialized kits to be replaced. Rights: OrsVisitManagementPost.",
"operationId":"replaceSubjectKits_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"srcSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsRequest"
},
"examples":{
"Replace Subject Kits Request":{
"description":"Replace Subject Kits Request",
"value":{
"nsKits":[
{
"subjectVisitNsinventoryId":"41200000000000000000000000000252",
"quantity":10
}
],
"kits":[
"5a"
],
"siteId":"B1B8327AFAA6412287106192AB5984EF",
"reason":"Some reason",
"reasonLabel":"kits are damaged"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SubjectReplaceKitsResponse"
},
"examples":{
"Replace Subject Kits Response":{
"description":"Replace Subject Kits Response",
"value":{
"replacedKits":[
{
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"kitNumber":1001,
"kitTypeName":"Kit A"
}
]
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or version. Or subject not found. Or site ID not found in site service",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Not Found Response":{
"description":"Replace Subject Kits Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or this operation is not allowed during the current subject statusOr invalid kit",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Bad Request Response":{
"description":"Replace Subject Kits Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Subject is randomized in error. Or not enough inventory",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Replace Subject Kits Server Error Response":{
"description":"Replace Subject Kits Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v4.0-studies-{studyId}-{mode}-subjects-{srcSubjectId}-replacekits-post",
"x-filename-id":"ec-ors-svc-rest-v4.0-studies-studyid-mode-subjects-srcsubjectid-replacekits-post"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/inventory/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary of serialized and non-serialized kits"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves a kit's summary. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitSummary_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
},
{
"name":"blockNumber",
"in":"query",
"description":"Block number",
"required":true,
"schema":{
"type":"string"
},
"example":"BLOCK-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTypeSummaryResponse"
}
},
"examples":{
"Get Kit Summary Response":{
"description":"Get Kit Summary Response",
"value":[
{
"kitTypes":[
{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"description":"Example kit type.",
"packageTypeId":1,
"packageType":"Bottle",
"totalKitNumbers":100,
"kitsDispensed":5,
"kitsDamaged":1,
"kitsAvailable":94,
"kitsInTransit":0,
"kitsReturnedToSite":0,
"kitsPendingDestruction":0,
"kitsExpired":0
}
]
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Not Found Response":{
"description":"Get Kit Summary Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location OR Invalid kitNumber OR Invalid Block Number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Bad Request Response":{
"description":"Get Kit Summary Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Server Error Response":{
"description":"Get Kit Summary Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-inventory-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-inventory-kit-types-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves kits for a site based on a given number range. Kit Range should be specified in the format as KIT_NUMBER:{From Kit number}:{To Kit number}. e.g. KIT_NUMBER:1:100.
Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getSiteKits_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT_NUMBER:10:100"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"required":true,
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":10
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponse"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"minKitNumber":10001,
"maxKitNumber":10001,
"totalReturnedUnits":2,
"distinctInventoryStatusIds":[
10
],
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID OR study still in design phase OR invalid site ID OR invalid subject ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kits matched the supplied filters."
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit filter values are invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
},
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update status for kits in a site"
],
"summary":"v5.0",
"description":"Updates a kit's status at a site. Added formInstanceId in response when kits are updated to pending destruction.
Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
},
"examples":{
"Update Kits Status Request":{
"description":"Update Kits Status Request",
"value":{
"kitsFilter":{
"kitRange":"KIT_NUMBER:10:100",
"searchString":"KIT",
"inventoryStatusIds":[
5,
10
],
"serialized":true
},
"nskits":[
{
"subjectVisitNSInventoryId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"lotId":"D313327EF13845169A8ADADDA435431E",
"inventoryStatusId":10
}
],
"kits":[
"C36A3197FDEE433FB5547EE83DE99E4B",
"E39FF55A445543A38D513325664F0B2D"
],
"inventoryStatusId":10,
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"returnedUnits":2,
"missingUnits":0,
"singleRowNSUpdate":true,
"quantity":1,
"reason":"Reconciled at site"
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateSiteKitsResponseV2"
},
"examples":{
"Update Kits Status Response":{
"description":"Update Kits Status Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"tempExcursionNumber":"001",
"formInstanceId":"89EE76326E984B548D594D592E5C7FC2"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating site kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kits matched the supplied selection."
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kits update request is invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-put",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-sites-siteid-inventory-kits-put"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits/{kitId}":{
"put":{
"tags":[
"Randomization and Supplies/Inventory APIs/Update kit status by kit ID"
],
"summary":"v5.0",
"description":"Updates a kit's status at a site. Added formInstanceId in response when kits are updated to pending destruction.
Rights: OrsInventoryPost and either OrsUnblinded or OrsBlinded.",
"operationId":"updateKits_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitId",
"in":"path",
"description":"ID of the kit.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteUserUpdateKitsStatusRequest"
},
"examples":{
"Update Kit Status Request":{
"description":"Update Kit Status Request",
"value":{
"inventoryStatusId":10,
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"reason":"Reconciled at site",
"returnedUnits":2,
"missingUnits":0,
"visitSrcId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"kits":[
"D313327EF13845169A8ADADDA435431E"
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/UpdateSiteKitsResponseV2"
},
"examples":{
"Update Kit Status Response":{
"description":"Update Kit Status Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"tempExcursionNumber":"001",
"formInstanceId":"89EE76326E984B548D594D592E5C7FC2"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while updating the site kit."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID or study still in design phase AND for invalid kit and study combination.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"The site kit was not found."
}
}
}
}
}
}
},
"400":{
"description":"For invalid subject or inventory status or invalid transition status for, kit does not belong to site.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit update request is invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-{kitId}-put",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-sites-siteid-inventory-kits-kitid-put"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/reports/kits/chainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Chain of Custody Unblinded report"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves the Chain of Custody report, result can be filtered on the basis of Location, Date Range, Kit Type, Subject Number and Kit List. Rights: UnblindedChainofCustodyReportPost. Added field: Block Number for a reconciliation shipment.",
"operationId":"getChainOfCustodyReport_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Chain Of Custody Report Request":{
"description":"Chain Of Custody Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"kitTypeIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Chain Of Custody Report Response":{
"description":"Chain Of Custody Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Kit Number",
"Transaction Date"
],
"data":[
[
"KIT-0001",
"2026-02-21"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-reports-kits-chainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-reports-kits-chainofcustody-post"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/reports/order-summary":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Order Summary report"
],
"summary":"v5.0",
"description":"Retrieves the Order Summary report.",
"operationId":"getOrderSummaryReport",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Order Summary Report Request":{
"description":"Order Summary Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"orderStatus",
"fieldType":"list",
"fieldValueList":[
"SHIPPED"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":" The result contains the following attributes \n\n 1. Shipped By SDF\n\n UUID of the site/depot which shipped the shipment. E.g. '41300000900000000000000000000001'\n\n 2. Received By SDF\n\n UUID of the site/depot which received the shipment. E.g. '41300000900000000000000000000001'\n\n 3. Received By SDF ID of Country\n\n UUID of the country of the site/depot which received the shipment. E.g. '41300000900000000000000000000001'\n\n 4. Shipment ID\n\n Name of shipment. E.g. 'Hyd125'\n\n 5. Shipment Type\n\n Type of shipment. E.g. 'Resupply'\n\n 6. Shipment Status\n\n Current status of the shipment. E.g. '4'\n\n 7. Date Requested\n\n Date on which the shipment was raised. E.g. '2020-01-20'\n\n 8. Date Received\n\n Date on which the shipment was received. null if the shipment is still not received\n\n 9. Days Outstanding\n\n No. of days till the shipment was received. If the shipment is still not received, this would be equal to no. of days since the shipment was requested (current date - date requested).\n\n 10. Date Cancelled/Marked Lost\n\n Date on which the shipment was canceled. null if not available (shipment not canceled)\n\n 11. Kit Count\n\n No. of kits in the shipment.\n\n 12. Kit Numbers in Shipment \n\n Kit numbers separated by `\\u7F`. E.g. \"300\\u7F400\"\n\n Use Character.toString ((char) 0x7F) as delimiter while concatenating multiple kits\n\n 13. Tracking Number\n\n Tracking number which is assigned to the shipment \n\n 14. Received By User\n\n UUID of the user which received the shipment. E.g. '41300000900000000000000000000001'\n\nResponse Payload: \n\n{\n\n \"result\": {\n\n \"hasMore\": \"true\",\n\n \"totalResults\": 221,\n\n \"count\": 1,\n\n \"limit\": 1,\n\n \"offset\": 0,\n\n \"columns\": [\n\n \"Shipped By SDF\",\n\n \"Received By SDF\",\n\n \"Received By SDF ID for Country\",\n\n \"Shipment ID\",\n\n \"Shipment Type\",\n\n \"Shipment Status\",\n\n \"Date Requested\",\n\n \"Date Received\",\n\n \"Days Outstanding\",\n\n \"Date Cancelled/Marked Lost\",\n\n \"Kit Count\",\n\n \"Kit Numbers in Shipment\",\n\n \"Tracking Number\",\n\n \"Temperature Monitor Status\",\n\n \"Received By User\"\n\n ],\n\n \"data\": [\n\n [\n\n \"09CA38D0A01145A285B2086729B4453C\",\n\n \"EB0F5FE4B75E4652800B90BE21521733\",\n\n \"EB0F5FE4B75E4652800B90BE21521733\",\n\n \"depo161\",\n\n \"Manual\",\n\n \"Received\",\n\n \"04-Jan-2022\",\n\n \"04-Jan-2022\",\n\n \"0\",\n\n \"\",\n\n \"4\",\n\n \"100324704780\",\n\n \"\",\n\n \"Yes\",\n\n \"0000000000000000000000000000000B\"\n\n ]\n\n ]\n\n },\n\n \"status\": \"success\",\n\n \"errorData\": null\n\n}",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Order Summary Report Response":{
"description":"Order Summary Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Order Number",
"Status"
],
"data":[
[
"ORDER-0001",
"SHIPPED"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-reports-order-summary-post",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-reports-order-summary-post"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/reports/unblindedrandreport":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Unblinded Randomization List report"
],
"summary":"v5.0",
"description":"Retrieves the Randomization List report. Rights: UnblindedRandomizationReportPost.",
"operationId":"getRandReport_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Unblinded Randomization Report Request":{
"description":"Unblinded Randomization Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"systemDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"rndListId",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Unblinded Randomization Report Response":{
"description":"Unblinded Randomization Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Rand Number",
"Status"
],
"data":[
[
"10",
"Assigned"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-reports-unblindedrandreport-post",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-reports-unblindedrandreport-post"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/reports/dispensations":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get the Subject Dispensation report"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves the Subject Dispensation report; Rights: SubjectDataReportPost. Site role: Blinded site user.",
"operationId":"getSubjectDispensationReport_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Subject Dispensation Report Request":{
"description":"Subject Dispensation Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Subject Dispensation Report Response":{
"description":"Subject Dispensation Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Site",
"Subject",
"Kit Number"
],
"data":[
[
"Site1001",
"S1001",
"KIT-0001"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"403":{
"description":"403 Forbidden.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to perform this operation.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Validation error - Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-reports-dispensations-post",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-reports-dispensations-post"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/reports/subjects":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Subject Data report"
],
"summary":"v5.0",
"description":"Retrieves the Subject Data report. Rights: SubjectDataReportPost. This API is used in Subject Visit (Blinded) Report, Subject Events Report and CTMS Report.",
"operationId":"getSubjectsReport_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"sessionToken",
"in":"query",
"description":"Session token.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Subjects Report Request":{
"description":"Subjects Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Subjects Report Response":{
"description":"Subjects Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Subject",
"Event Type"
],
"data":[
[
"S1001",
"VISIT"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-reports-subjects-post",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-reports-subjects-post"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/randlists/{rndlistid}/randnumbers":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Numbers/Get randomization number"
],
"summary":"v5.0",
"description":"Versioned to return sequenceNumber along with the randomization number. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandNum_3",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"S1001"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"blockedBy",
"in":"query",
"description":"ID of the entity which has blocked the randomization number.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"status",
"in":"query",
"description":"Status of the randomization number.",
"schema":{
"type":"number"
},
"example":3
},
{
"name":"cohortId",
"in":"query",
"description":"ID of the cohort.",
"schema":{
"type":"string"
},
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
},
{
"name":"groupId",
"in":"query",
"description":"ID of the group in a stratum.",
"schema":{
"type":"string"
},
"example":"GROUP-A"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandNumberResponse"
},
"examples":{
"Get Rand Numbers Response":{
"description":"Get Rand Numbers Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"randNumbers":[
{
"randNumberId":"D313327EF13845169A8ADADDA435431E",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"2026-02-21T06:45:00Z",
"randNumber":10,
"blockNumber":1,
"randStatusId":3,
"randStatusKey":"Assigned",
"treatmentId":"B1B8327AFAA6412287106192AB5984EF",
"externalTreatmentId":"ARM-A",
"blockingParamName":"site",
"blockingParamId":"SITE-001",
"blockingParamValue":"Site1001",
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"subjectNumber":"S1001",
"cohortId":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"cohortName":"Demo Cohort 1001",
"sequenceNumber":1001
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version, or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-randlists-{rndlistid}-randnumbers-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-randlists-rndlistid-randnumbers-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/randlists":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves a randomization list based on the query parameter minimizationList, which can take one of the following values: - 1 = Only minimization list
- 0 = Non-minimization list
- null = All lists
Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlist_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"minimizationLists",
"in":"query",
"description":"Integer property for type of rand list.",
"schema":{
"type":"string"
},
"example":"y"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO"
},
"examples":{
"Get Randlists Response":{
"description":"Get Randlists Response",
"value":{
"randListId":"B1B8327AFAA6412287106192AB5984EF",
"name":"RandList-01",
"description":"Randomization list for Study",
"inUse":"y"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-randlists-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-randlists-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/randlists/{rndlistid}":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list by ID"
],
"summary":"v5.0",
"description":"Retrieves a randomization list by ID. This API version returns useSequenceNumber to identify whether a given randomization list has a Sequence Number or not. Rights: OrsRandListGet and OrsUnblinded.",
"operationId":"getRandlistById_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"rndlistid",
"in":"path",
"description":"ID of the randomization list.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO5"
},
"examples":{
"Get Randlist By Id Response":{
"description":"Get Randlist By Id Response",
"value":{
"randListId":"B1B8327AFAA6412287106192AB5984EF",
"name":"RandList-01",
"description":"Randomization list for Study",
"inUse":"y",
"isMinimization":"n",
"useSequenceNumber":"y"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID, invalid study version or if a randomization list isn't found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-randlists-{rndlistid}-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-randlists-rndlistid-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/shipments/{shipmentId}/kits":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Kits/Get kits"
],
"summary":"v5.0",
"description":"Retrieves a serialized and non-serialized kit's details by order. Rights: OrsInventoryGet, OrsUnblinded. Added new field: nsKits to the response.",
"operationId":"getKits_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit/Lot number.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT-0001"
},
{
"name":"orderBy",
"in":"query",
"description":"Specify the parameter by which the kits are ordered.",
"required":true,
"schema":{
"type":"string"
},
"example":"kitNumber"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentKitsResponseV5"
},
"examples":{
"Get Shipment Kits Response":{
"description":"Get Shipment Kits Response",
"value":{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"kitTypes":[
{
"id":"89EE76326E984B548D594D592E5C7FC2",
"kitTypeName":"Kit A",
"description":"Non dosing kit",
"packageTypeId":5,
"packageTypeKey":"INHALER",
"unitsPerKit":5,
"kitTypeSrcId":"C36A3197FDEE433FB5547EE83DE99E4B",
"kits":[
{
"id":"D313327EF13845169A8ADADDA435431E",
"kitNumber":1001,
"sequenceNumber":1,
"barcode":"12345",
"returnedUnits":0,
"missingUnits":0,
"depotReturnedUnits":0,
"inventoryStatusId":5,
"materialId":"MaterialId0000001",
"itemNumber":"ItemNumber0000001",
"kitNumberUTF":"12345"
}
],
"nsKits":[
]
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Not found"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-shipments-{shipmentId}-kits-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-shipments-shipmentid-kits-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. In this version, tempExcursionNumber is added to return temperature excursion number of the kit. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryDTOV5"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"D313327EF13845169A8ADADDA435431E",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"message":"Order not found for shipmentId 89EE76326E984B548D594D592E5C7FC2."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves details of the orders. In this version, tempExcursionNumber is added to return temperature excursion number of the kit in an order. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponseV5"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"D313327EF13845169A8ADADDA435431E",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"orderId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/shipments/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Get shipment by shipment ID"
],
"summary":"v5.0",
"description":"Retrieves shipment containing source and destination locations by shipment ID. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getShipment_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ShipmentTO"
},
"examples":{
"Get Shipment Response":{
"description":"Get Shipment Response",
"value":{
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"shipmentNumber":"SHIP-0001",
"statusId":1
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase' or 'Invalid shipment ID'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Shipment not found."
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-shipments-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-shipments-shipmentid-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded, BlindedDepot.",
"operationId":"getShipments_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-0001"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":5
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV2"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"123",
"statusId":5,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Not found"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/supply/settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Get supply settings"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Retrieves supply settings. This version includes new field confirmDispensation in Response. Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsGet.",
"operationId":"getSupplySettings_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV5"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-supply-settings-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-supply-settings-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Updates a study's supply settings by study ID. This version includes new field confirmDispensation in Response.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV5"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Use latest version instead. Retrieves dispensation history for a study, by subject and visit ID. Rights: OrsSubjectVisitGet.",
"operationId":"getDispensationHistory_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponseV5"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":1001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:30:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"packageTypeId":2,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"lastModifiedDate":"2026-02-22T09:45:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"conserved":false,
"allowReplacement":false,
"instanceNumber":1
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/unblinded-disp-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get unblinded dispensation history for all subjects"
],
"summary":"v5.0",
"description":"Retrieves unblinded dispensation history for all subjects within the study. This version includes new fields in response for non-serialized kits: - subjectVisitNsInventoryId
lotId - quantity
- lotNumber
- nsInventoryVersionStart
- visitManualAssignment
- nsInventoryId
- userId
- originalSubjectVisitNSInventory
- notDispensedToSubject
Rights: OrsSubjectVisitGet.",
"operationId":"getUnblindedAllDispHistory_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"integer",
"format":"int32"
},
"example":100
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"number"
},
"example":1
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"audit",
"in":"query",
"description":"Value of audit parameter",
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponse"
},
"examples":{
"Unblinded Dispensation History Response":{
"description":"Unblinded Dispensation History Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"resultData":[
{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"instanceNumber":1,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"inventoryId":"699EF3745FC545589F186D2198F3C65E",
"kitNumber":123,
"kitTypeSrcId":"B1B8327AFAA6412287106192AB5984EF",
"inventoryStatusId":5,
"inventoryStatus":"Available",
"dispensationDate":"2026-02-24T00:00:00Z",
"barcode":"61234",
"dispensationConfirmed":true,
"dose":1,
"measurement":"mg",
"frequency":"Once daily",
"returnedUnits":0,
"missingUnits":0,
"conserved":false,
"kitNumberUTF":"KIT-000123",
"titrationOption":"maintain",
"operationType":"CREATED",
"subjectVisitNsInventoryId":"B1B8327AFAA6412287106192AB5984EF",
"lotId":"D313327EF13845169A8ADADDA435431E",
"quantity":2,
"lotNumber":"mf1",
"nsInventoryVersionStart":"2026-02-21T06:30:00Z",
"visitManualAssignment":false,
"nsInventoryId":"89EE76326E984B548D594D592E5C7FC2",
"userId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"originalSubjectVisitNSInventory":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA",
"notDispensedToSubject":0
}
]
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version. Or subject not found.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid limit or offset values",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-unblinded-disp-history-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-unblinded-disp-history-get"
}
},
"/ec-ors-svc/rest/v5.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Use latest version instead. Retrieves visit by visit ID. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_12",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string",
"format":"UUID"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Use latest version instead. Randomize a subject and/or dispense kits during a randomization or dispensation visit. Rights: OrsVisitManagementPost.",
"operationId":"visit_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV4"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:30:00",
"titrationOption":"maintain",
"userConfirmationTaken":true
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v5.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v5.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/inventory/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary of serialized and non-serialized kits"
],
"summary":"v6.0",
"description":"Retrieves a kit's summary. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitSummary_4",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
},
{
"name":"blockNumber",
"in":"query",
"description":"Block number",
"required":true,
"schema":{
"type":"string"
},
"example":"BLOCK-001"
},
{
"name":"tempExcursionNumber",
"in":"query",
"description":"tempExcursionNumber",
"required":true,
"schema":{
"type":"string"
},
"example":"TEMP-001"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTypeSummaryResponse"
}
},
"examples":{
"Get Kit Summary Response":{
"description":"Get Kit Summary Response",
"value":[
{
"kitTypes":[
{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"description":"Example kit type.",
"packageTypeId":1,
"packageType":"Bottle",
"totalKitNumbers":100,
"kitsDispensed":5,
"kitsDamaged":1,
"kitsAvailable":94,
"kitsInTransit":0,
"kitsReturnedToSite":0,
"kitsPendingDestruction":0,
"kitsExpired":0
}
]
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Not Found Response":{
"description":"Get Kit Summary Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location OR Invalid kitNumber OR Invalid Block Number OR Invalid temperature excursion number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Bad Request Response":{
"description":"Get Kit Summary Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Server Error Response":{
"description":"Get Kit Summary Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-inventory-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-inventory-kit-types-get"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Retrieves kits for a site based on a given number range. Kit Range should be specified in the format as KIT_NUMBER:{From Kit number}:{To Kit number}. e.g. KIT_NUMBER:1:100.
Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getSiteKits_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT_NUMBER:10:100"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"required":true,
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":10
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponse"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"minKitNumber":10001,
"maxKitNumber":10001,
"totalReturnedUnits":2,
"distinctInventoryStatusIds":[
10
],
"blindedLotsExistsInStudy":true,
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID OR study still in design phase OR invalid site ID OR invalid subject ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kits matched the supplied filters."
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit filter values are invalid."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/reports/kits/chainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Chain of Custody Unblinded report"
],
"summary":"v6.0",
"description":"Retrieves the Chain of Custody report, result can be filtered on the basis of Location, Date Range, Kit Type, Subject Number, Kit List and Temperature Excursion Number. Rights: UnblindedChainofCustodyReportPost. Added field: Temperature Excursion Number for a reconciliation shipment.",
"operationId":"getChainOfCustodyReport_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Chain Of Custody Report Request":{
"description":"Chain Of Custody Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"kitTypeIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Chain Of Custody Report Response":{
"description":"Chain Of Custody Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Kit Number",
"Transaction Date"
],
"data":[
[
"KIT-0001",
"2026-02-21"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-reports-kits-chainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-reports-kits-chainofcustody-post"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/reports/dispensations":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get the Subject Dispensation report"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Retrieves the Subject Dispensation report; Rights: SubjectDataReportPost. Site role: Blinded site user.",
"operationId":"getSubjectDispensationReport_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Subject Dispensation Report Request":{
"description":"Subject Dispensation Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Subject Dispensation Report Response":{
"description":"Subject Dispensation Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Site",
"Subject",
"Kit Number"
],
"data":[
[
"Site1001",
"S1001",
"KIT-0001"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"403":{
"description":"403 Forbidden.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to perform this operation.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Validation error - Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-reports-dispensations-post",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-reports-dispensations-post"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/randlists":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list"
],
"summary":"v6.0",
"description":"Retrieves a randomization list. This API version returns useSequenceNumber to identify whether a given randomization list has a Sequence Number or not.",
"operationId":"getRandlist_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"minimizationLists",
"in":"query",
"description":"Integer property for type of rand list.",
"schema":{
"type":"string"
},
"example":"y"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO5"
},
"examples":{
"Get Randlists Response":{
"description":"Get Randlists Response",
"value":{
"randListId":"B1B8327AFAA6412287106192AB5984EF",
"name":"RandList-01",
"description":"Randomization list for Study",
"inUse":"y"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-randlists-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-randlists-get"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. In this version, tempExcursionNumber is added to return temperature excursion number of the kit. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryDTOV6"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"D313327EF13845169A8ADADDA435431E",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"message":"Order not found for shipmentId 89EE76326E984B548D594D592E5C7FC2."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Retrieves details of the orders. In this version, tempExcursionNumber is added to return temperature excursion number of the kit in an order. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponseV6"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"D313327EF13845169A8ADADDA435431E",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"B1B8327AFAA6412287106192AB5984EF",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded, BlindedDepot.",
"operationId":"getShipments_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"active"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-0001"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":5
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV2"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"123",
"statusId":5,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Not found"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/supply/settings":{
"get":{
"tags":[
"Randomization and Supplies/Settings APIs/Get supply settings"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Retrieves supply settings. This version includes new field confirmDispensation in Response.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsGet.",
"operationId":"getSupplySettings_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV10"
},
"examples":{
"Get Supply Settings Response":{
"description":"Get Supply Settings Response",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true,
"dispenseByLowestKitNumber":true,
"allowDoseHold":true
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-supply-settings-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-supply-settings-get"
},
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Updates a study's supply settings by study ID. This version includes new field dispenseByLowestKitNumber in Request.
Rights: SupplySettingRightsPost.
Required sponsor roles are: clinical supply manager and site manager.",
"operationId":"updateSupplySettings_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV6"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true,
"dispenseByLowestKitNumber":true,
"allowDoseHold":true
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Retrieves dispensation history for a study, by subject and visit ID. Rights: OrsSubjectVisitGet. See additional fields for barcodes and dispensation Confirmed for data on confirmation of dispensed kits.",
"operationId":"getDispensationHistory_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponse"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":1001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:30:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"packageTypeId":2,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"lastModifiedDate":"2026-02-22T09:45:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"conserved":false,
"instanceNumber":1,
"barcode":"1236",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"kitNumberUTF":"000AB123",
"inventoryStatusName":"Dispensed",
"userId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"titration":"maintain",
"originalKit":"Kit-345",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"mf1",
"originalLotNumber":"mf1",
"dosingInstruction":"once daily"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid Parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v6.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Use latest version instead. Retrieves visit by visit ID. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_13",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v6.0",
"description":"Deprecated: Use latest version instead. Randomize a subject and/or dispense kits during a randomization or dispensation visit. Rights: OrsVisitManagementPost.",
"operationId":"visit_12",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV6"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:30:00",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v6.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v6.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/inventory/kit-types":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Get kit summary of serialized and non-serialized kits"
],
"summary":"v7.0",
"description":"Retrieves a serialized and non-serialized kit's summary. Rights: OrsInventoryGet and OrsUnblinded.",
"operationId":"getKitSummary_5",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
{
"name":"location",
"in":"query",
"description":"Location of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"SITE-001"
},
{
"name":"lotId",
"in":"query",
"description":"ID of the lot.",
"required":true,
"schema":{
"type":"string"
},
"example":"LOT-001"
},
{
"name":"kitTypeId",
"in":"query",
"description":"ID of the kit type.",
"required":true,
"schema":{
"type":"string"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"kitStatus",
"in":"query",
"description":"Status of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"Available"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"1001-1010"
},
{
"name":"labelGroupId",
"in":"query",
"description":"ID of the label group.",
"required":true,
"schema":{
"type":"string"
},
"example":"LABEL-001"
},
{
"name":"kitNumber",
"in":"query",
"description":"Kit number",
"required":true,
"schema":{
"type":"string"
},
"example":1001
},
{
"name":"blockNumber",
"in":"query",
"description":"Block number",
"required":true,
"schema":{
"type":"string"
},
"example":"BLOCK-001"
},
{
"name":"tempExcursionNumber",
"in":"query",
"description":"tempExcursionNumber",
"required":true,
"schema":{
"type":"string"
},
"example":"TEMP-001"
},
{
"name":"serialized",
"in":"query",
"description":"serialized",
"schema":{
"type":"boolean"
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTypeSummaryResponse"
}
},
"examples":{
"Get Kit Summary Response":{
"description":"Get Kit Summary Response",
"value":[
{
"kitTypes":[
{
"kitTypeId":"9B83BFB48C5A41C59775E4D8D22D8B26",
"kitTypeName":"KitType-01",
"description":"Example kit type.",
"packageTypeId":1,
"packageType":"Bottle",
"totalKitNumbers":100,
"kitsDispensed":5,
"kitsDamaged":1,
"kitsAvailable":94,
"kitsInTransit":0,
"kitsReturnedToSite":0,
"kitsPendingDestruction":0,
"kitsExpired":0
}
]
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Not Found Response":{
"description":"Get Kit Summary Not Found Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"No data found.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid kit status OR Invalid kit range filter OR Invalid label group in kit filters OR Invalid kit type OR Invalid Lot OR Invalid location OR Invalid kitNumber OR Invalid Block Number OR Invalid temperature excursion number",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Bad Request Response":{
"description":"Get Kit Summary Bad Request Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Get Kit Summary Server Error Response":{
"description":"Get Kit Summary Server Error Response",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"An unexpected error occurred.",
"details":{
"context":"inventory",
"reason":"Review the error code and message for the failed inventory request."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-inventory-kit-types-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-inventory-kit-types-get"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"v7.0",
"description":"Retrieves kits for a site based on a given number range. Kit Range should be specified in the format as KIT_NUMBER:{From Kit number}:{To Kit number}. e.g. KIT_NUMBER:1:100.
Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getSiteKits_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT_NUMBER:10:100"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"required":true,
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":10
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponse"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"minKitNumber":10001,
"maxKitNumber":10001,
"totalReturnedUnits":2,
"distinctInventoryStatusIds":[
10
],
"distinctNSInventoryStatusIds":[
10
],
"blindedLotsExistsInStudy":true,
"updatableKitsTotal":1,
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID OR study still in design phase OR invalid site ID OR invalid subject ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kits matched the supplied filters."
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit filter values are invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/reports/kits/chainofcustody":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get Kit Chain of Custody Unblinded report"
],
"summary":"v7.0",
"description":"Retrieves the Chain of Custody report, result can be filtered on the basis of Location, Date Range, Kit Type, Subject Number, Kit List and Temperature Excursion Number. Rights: UnblindedChainofCustodyReportPost. Added field: Dispensation Visit and Instance Number.",
"operationId":"getChainOfCustodyReport_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Chain Of Custody Report Request":{
"description":"Chain Of Custody Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"transDt",
"fieldType":"date",
"fieldValueList":[
"2026-02-01",
"2026-02-28"
]
},
{
"fieldName":"kitTypeIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Chain Of Custody Report Response":{
"description":"Chain Of Custody Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Kit Number",
"Transaction Date"
],
"data":[
[
"KIT-0001",
"2026-02-21"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Study not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-reports-kits-chainofcustody-post",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-reports-kits-chainofcustody-post"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/reports/dispensations":{
"post":{
"tags":[
"Randomization and Supplies/Report APIs/Get the Subject Dispensation report"
],
"summary":"v7.0",
"description":"Retrieves the Subject Dispensation report; Rights: SubjectDataReportPost. Site role: Blinded site user.",
"operationId":"getSubjectDispensationReport_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"Subject Dispensation Report Request":{
"description":"Subject Dispensation Report Request",
"value":{
"offset":0,
"limit":100,
"fieldSpecsList":[
{
"fieldName":"siteIds",
"fieldType":"list",
"fieldValueList":[
"B1B8327AFAA6412287106192AB5984EF"
]
},
{
"fieldName":"subjectIds",
"fieldType":"list",
"fieldValueList":[
"C36A3197FDEE433FB5547EE83DE99E4B"
]
}
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ReportBaseResponse"
},
"examples":{
"Subject Dispensation Report Response":{
"description":"Subject Dispensation Report Response",
"value":{
"result":{
"offset":0,
"limit":100,
"count":1,
"hasMore":"false",
"totalResults":1,
"columns":[
"Site",
"Subject",
"Kit Number"
],
"data":[
[
"Site1001",
"S1001",
"KIT-0001"
]
]
},
"status":"success",
"errorData":""
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"403":{
"description":"403 Forbidden.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Forbidden":{
"description":"Forbidden",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"FORBIDDEN",
"errorMessage":"You do not have permission to perform this operation.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Validation error - Invalid search criteria.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_SEARCH_CRITERIA",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"For study not found or invalid study",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-reports-dispensations-post",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-reports-dispensations-post"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/randlists":{
"get":{
"tags":[
"Randomization and Supplies/Randomization List APIs/Lists/Get randomization list"
],
"summary":"v7.0",
"description":"Retrieves a randomization list. This API version returns useSequenceNumber to identify whether a given randomization list has a Sequence Number or not.",
"operationId":"getRandlist_6",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"minimizationLists",
"in":"query",
"description":"Integer property for type of rand list.",
"schema":{
"type":"string"
},
"example":"y"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandListTO"
},
"examples":{
"Get Randlists Response":{
"description":"Get Randlists Response",
"value":{
"randListId":"B1B8327AFAA6412287106192AB5984EF",
"name":"RandList-01",
"description":"Randomization list for Study",
"inUse":"y"
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"404":{
"description":"Appears for invalid study ID or invalid study version.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-randlists-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-randlists-get"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v7.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. In this version, tempExcursionNumber is added to return temperature excursion number of the kit. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrdersInventoryDTOV7"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"message":"Order not found for shipmentId 89EE76326E984B548D594D592E5C7FC2."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v7.0",
"description":"Deprecated: Retrieves details of the orders. In this version, tempExcursionNumber is added to return temperature excursion number of the kit in an order. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_7",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includePooledShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude pooled shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponseV7"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"v7.0",
"description":"Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded, BlindedDepot.",
"operationId":"getShipments_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"transactionId",
"in":"query",
"description":"String value for transaction ID of shipment.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV7"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"123",
"statusId":5,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Not found"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/supply/settings":{
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v7.0",
"description":"Deprecated: Updates a study's supply settings by study ID. This version includes new field confirmDispensation in request.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV7"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true,
"dispenseByLowestKitNumber":true,
"allowDoseHold":true,
"quarantineWithoutTempMonitor":false
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v7.0",
"description":"Deprecated: Retrieves dispensation history for a study, by subject and visit ID. Rights: OrsSubjectVisitGet. Added additional field dosingUnblinded.",
"operationId":"getDispensationHistory_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponse"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":1001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:30:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"packageTypeId":2,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"lastModifiedDate":"2026-02-22T09:45:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"conserved":false,
"instanceNumber":1,
"barcode":"1236",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"kitNumberUTF":"000AB123",
"inventoryStatusName":"Dispensed",
"userId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"titration":"maintain",
"originalKit":"Kit-345",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"mf1",
"originalLotNumber":"mf1",
"dosingInstruction":"once daily"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v7.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v7.0",
"description":"Deprecated: Use latest version instead. Retrieves visit by visit ID. This is a new version of the API for adding additional attribute conserved, for partial dispensation. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_14",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v7.0",
"description":"Deprecated: Use latest version instead. Randomize a subject and/or dispense kits during a randomization or dispensation visit. Rights: OrsVisitManagementPost.",
"operationId":"visit_13",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV7"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:30:00",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v7.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v7.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v8.0/studies/{studyId}/{mode}/sites/{siteId}/inventory/kits":{
"get":{
"tags":[
"Randomization and Supplies/Inventory APIs/Search for kits in a given range for a site"
],
"summary":"v8.0",
"description":"Retrieves kits for a site based on a given number range and filters kits as serialized or non-serialized. Kit Range should be specified in the format as KIT_NUMBER:{From Kit number}:{To Kit number}. e.g. KIT_NUMBER:1:100.
Rights: OrsInventoryGet and either OrsUnblinded or OrsBlinded.",
"operationId":"getSiteKits_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"siteId",
"in":"path",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT"
},
{
"name":"kitRange",
"in":"query",
"description":"Range of the kit.",
"required":true,
"schema":{
"type":"string"
},
"example":"KIT_NUMBER:10:100"
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"inventoryStatusId",
"in":"query",
"description":"List of inventory status IDs.",
"required":true,
"schema":{
"type":"array",
"items":{
"type":"integer",
"format":"int32"
}
},
"example":10
},
{
"name":"subjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"serialized",
"in":"query",
"description":"Serialized",
"schema":{
"type":"boolean"
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SiteKitDetailsResponse"
},
"examples":{
"Get Site Kits Response":{
"description":"Get Site Kits Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"minKitNumber":10001,
"maxKitNumber":10001,
"totalReturnedUnits":2,
"distinctInventoryStatusIds":[
10
],
"distinctNSInventoryStatusIds":[
10
],
"blindedLotsExistsInStudy":true,
"updatableKitsTotal":1,
"kits":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"kitNumber":10001,
"inventoryStatusId":10,
"inventoryStatus":"Dispensed",
"shipmentId":"C36A3197FDEE433FB5547EE83DE99E4B",
"shipmentNumber":"SHIP-0001",
"receivedDate":"2026-02-21T23:36:32.079Z",
"comment":"Received at site"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-500",
"errorMessage":"Unexpected error while retrieving site kits."
}
}
}
}
}
}
},
"404":{
"description":"For invalid study ID OR study still in design phase OR invalid site ID OR invalid subject ID",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-404",
"errorMessage":"No site kits matched the supplied filters."
}
}
}
}
}
}
},
"400":{
"description":"For invalid kit range format",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INV-400",
"errorMessage":"The site kit filter values are invalid."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-sites-{siteId}-inventory-kits-get",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-sites-siteid-inventory-kits-get"
}
},
"/ec-ors-svc/rest/v8.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"[Deprecated]: v8.0",
"description":"Deprecated: Retrieves an order's details by shipment ID. In this version, non-serialized inventory details are added in the order. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrdersInventoryDTOV8"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT"
}
],
"nsInventory":[
{
"nsInventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"quantity":5,
"lotNumber":"lot1",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"transactionId":"D313327EF13845169A8ADADDA435431E"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"message":"Order not found for shipmentId 89EE76326E984B548D594D592E5C7FC2."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v8.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"[Deprecated]: v8.0",
"description":"Deprecated: Retrieves details of the orders. In this version, non-serialized inventory details are added in the orders. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_8",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includePooledShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude pooled shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponseV8"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT"
}
],
"nsInventory":[
{
"nsInventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"quantity":5,
"lotNumber":"lot1",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"transactionId":"D313327EF13845169A8ADADDA435431E"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v8.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"v8.0",
"description":"Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded, BlindedDepot.",
"operationId":"getShipments_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":1
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9B83BFB48C5A41C59775E4D8D22D8B26"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"transactionId",
"in":"query",
"description":"String value for transaction ID of shipment.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV8"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"123",
"statusId":5,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Not found"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v8.0/studies/{studyId}/{mode}/supply/settings":{
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v8.0",
"description":"Deprecated: Updates a study's supply settings by study ID. This version includes new fields in request: Randomize only when all kits are available at Site and Select Kits.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTOV8"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true,
"dispenseByLowestKitNumber":true,
"allowDoseHold":true,
"quarantineWithoutTempMonitor":false,
"randomizeWhenKitsAvailable":false,
"allKitsSelectedForRandomization":false,
"kitsSelectedForRandomization":[
"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"6A2D911A4E5E4D61B29A1CC73E5402AB"
]
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v8.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v8.0",
"description":"Deprecated: Retrieves dispensation history for a study, by subject and visit ID. Rights: OrsSubjectVisitGet. Added additional field kitNumberUTF8.",
"operationId":"getDispensationHistory_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponse"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":1001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:30:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"packageTypeId":2,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"lastModifiedDate":"2026-02-22T09:45:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"conserved":false,
"instanceNumber":1,
"barcode":"1236",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"kitNumberUTF":"000AB123",
"inventoryStatusName":"Dispensed",
"userId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"titration":"maintain",
"originalKit":"Kit-345",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"mf1",
"originalLotNumber":"mf1",
"dosingInstruction":"once daily"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v8.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v8.0",
"description":"Deprecated: Use latest version instead. Retrieves visit by visit ID. This is a new version of the API for adding additional attribute titrationKitLabel for blinded kit label. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_15",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v8.0",
"description":"Deprecated: Use latest version instead. Randomize a subject and/or dispense kits during a randomization or dispensation visit. This new version also contains additional attributes for blinded kit labels in titrations: titrationKitLabel. Rights: OrsVisitManagementPost.",
"operationId":"visit_14",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV7"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:30:00",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResult"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v8.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v8.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-ors-svc/rest/v9.0/studies/{studyId}/{mode}/orders/{shipmentId}":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get order details by a shipment ID"
],
"summary":"v9.0",
"description":"Retrieves an order's details by shipment ID. In this version, material ID is added in the order. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrder_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"shipmentId",
"in":"path",
"description":"ID of the shipment.",
"required":true,
"schema":{
"type":"string"
},
"example":"89EE76326E984B548D594D592E5C7FC2"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrdersInventoryDTOV8"
},
"examples":{
"Get Order Response":{
"description":"Get Order Response",
"value":{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT"
}
],
"nsInventory":[
{
"nsInventoryId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"quantity":5,
"lotNumber":"lot1",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"transactionId":"D313327EF13845169A8ADADDA435431E"
}
],
"version":1
}
}
}
}
}
},
"404":{
"description":"Order not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Get Order Not Found Response":{
"description":"Get Order Not Found Response",
"value":{
"status":"error",
"message":"Order not found for shipmentId 89EE76326E984B548D594D592E5C7FC2."
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v9.0-studies-{studyId}-{mode}-orders-{shipmentId}-get",
"x-filename-id":"ec-ors-svc-rest-v9.0-studies-studyid-mode-orders-shipmentid-get"
}
},
"/ec-ors-svc/rest/v9.0/studies/{studyId}/{mode}/orders":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Orders/Get orders"
],
"summary":"v9.0",
"description":"Retrieves details of the orders. In this version, material ID is added in the orders. If a kit list is disabled, the shipment will be excluded from the Orders API. Rights: OrsInventoryGet, OrsUnblinded.",
"operationId":"getOrders_9",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"status",
"in":"query",
"description":"Status of the order.",
"schema":{
"type":"string"
},
"example":"PENDING"
},
{
"name":"startDate",
"in":"query",
"description":"The starting date and time (optional). If you don't specify the time, the date range begins after midnight (UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-01"
},
{
"name":"endDate",
"in":"query",
"description":"The ending date and time (optional). If you don't specify the time, the date range stops before midnight (23:59:59 UTC) for the specified date. The accepted date and time formats are: dd-MMM-yyyy HH:mm:ss.SSS, dd-MMM-yyyy HH:mm:ss, or dd-MMM-yyyy HH:mm.",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-02-28"
},
{
"name":"includeReconShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude destruction shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includeDepotShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude depot to depot shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"includePooledShipments",
"in":"query",
"description":"By Default this value is set to False, which the default API will exclude pooled shipments.",
"required":true,
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":100
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/OrderInventoryPagedListResponseV7"
},
"examples":{
"Get Orders Response":{
"description":"Get Orders Response",
"value":{
"shipments":[
{
"order":{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"depotId":"B1B8327AFAA6412287106192AB5984EF",
"depotVersionStart":"2026-02-01T00:00:00Z",
"jobInstanceId":"D313327EF13845169A8ADADDA435431E",
"orderDate":"2026-02-20T10:15:00Z",
"orderStatusId":5,
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersionStart":"2026-01-15T00:00:00Z",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"shipDate":"2026-02-24T00:00:00Z",
"shipmentId":"89EE76326E984B548D594D592E5C7FC2",
"trackingNumber":"12345",
"trackingNumberUrl":"http://www.site.com",
"orderType":"MANUAL",
"orderTypeId":5,
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"CREATED",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"DATA ENTRY ERROR",
"comment":"Updated with new values",
"isReconciliation":true,
"reportId":"5BB2C53538C841268AB4E4A1E640D0C9",
"isDepotShipment":true,
"includePooledShipments":true,
"shippingAddressId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"shippingAddress":"City,Country,Local Address",
"deliveryNumber":"Order123",
"shipmentReceiptDate":"2026-02-26T00:00:00Z",
"shipmentReceivedById":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"orderId":"3D7A4A0D4D8C4A179E2A75E2E0D1C9F2"
},
"inventory":[
{
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"doNotCount":5,
"doNotShip":5,
"expirationDate":"2026-12-31T00:00:00Z",
"inventoryStatusId":1,
"kitTypeId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"kitTypeVersionStart":"2026-01-15T00:00:00Z",
"labelGroupId":"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"labelGroupVersionStart":"2026-01-15T00:00:00Z",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotVersionStart":"2026-01-15T00:00:00Z",
"sequenceNumber":5,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"siteVersionStart":"2026-01-15T00:00:00Z",
"kitNumber":5,
"inventorySourceId":"5BB2C53538C841268AB4E4A1E640D0C9",
"inventorySourceVersionStart":"2026-02-21T06:30:00Z",
"kitNumberUTF":"24-1",
"blockNumber":"245",
"tempExcursionNumber":"001",
"inventoryId":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
],
"kitTypes":[
{
"id":"4A4F2C3D1E6B4A6FB7A8C9D0E1F2A3B4",
"kitTypeSrcId":"2AC584703F7B4DCC8D8A8B282A4D09E2",
"quantity":5,
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"minExpirationDate":"2026-12-31T00:00:00Z",
"userId":"C36A3197FDEE433FB5547EE83DE99E4B",
"operationType":"modified",
"objectVersionNumber":1,
"softwareVersionNumber":1,
"reason":"test",
"comment":"test",
"versionStart":"2026-02-21T06:30:00Z",
"versionEnd":"9999-12-31T23:59:59Z",
"pooledKitId":"Pooled Kit01",
"lotNumber":"MLOT"
}
],
"version":1
}
],
"totalResults":1,
"count":1,
"hasMore":false,
"limit":100,
"offset":0
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"400":{
"description":"Invalid order status value",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"Invalid request parameters.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v9.0-studies-{studyId}-{mode}-orders-get",
"x-filename-id":"ec-ors-svc-rest-v9.0-studies-studyid-mode-orders-get"
}
},
"/ec-ors-svc/rest/v9.0/studies/{studyId}/{mode}/shipments":{
"get":{
"tags":[
"Randomization and Supplies/Shipment APIs/Shipments/Search shipments for a study"
],
"summary":"v9.0",
"description":"Searches for shipments associated with a study by study ID. Rights: OrsInventoryGet, OrsUnblinded, BlindedDepot.",
"operationId":"getShipments_11",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"searchString",
"in":"query",
"description":"Search string.",
"required":true,
"schema":{
"type":"string"
},
"example":"SHIP-0001"
},
{
"name":"limit",
"in":"query",
"description":"Maximum number of records to display per page.",
"schema":{
"type":"string",
"default":"100"
},
"example":100
},
{
"name":"offset",
"in":"query",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"statusId",
"in":"query",
"description":"ID of the status.",
"required":true,
"schema":{
"type":"number"
},
"example":5
},
{
"name":"recon",
"in":"query",
"description":"Boolean value for recon.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"originId",
"in":"query",
"description":"String value for origin of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"D313327EF13845169A8ADADDA435431E"
},
{
"name":"destinationId",
"in":"query",
"description":"String value for destination of shipment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"depotShipment",
"in":"query",
"description":"Boolean value for looking for depot shipments.",
"required":true,
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"transactionId",
"in":"query",
"description":"String value for transaction ID of shipment.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ViewShipmentResponseV9"
},
"examples":{
"Get Shipments Response":{
"description":"Get Shipments Response",
"value":{
"offset":0,
"limit":100,
"count":1,
"hasMore":false,
"totalResults":1,
"shipments":[
{
"shipmentId":"B1B8327AFAA6412287106192AB5984EF",
"shipmentNumber":"123",
"statusId":5,
"createdDate":"2026-02-21T06:30:00Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"message":"Server error"
}
}
}
}
}
},
"404":{
"description":"'Invalid study ID', 'Study still in design phase'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"message":"Not found"
}
}
}
}
}
}
},
"x-internal-id":"ec-ors-svc-rest-v9.0-studies-{studyId}-{mode}-shipments-get",
"x-filename-id":"ec-ors-svc-rest-v9.0-studies-studyid-mode-shipments-get"
}
},
"/ec-ors-svc/rest/v9.0/studies/{studyId}/{mode}/supply/settings":{
"put":{
"tags":[
"Randomization and Supplies/Settings APIs/Update supply settings"
],
"summary":"[Deprecated]: v9.0",
"description":"Deprecated: Updates a study's supply settings by study ID. This version includes new fields: tempExcursionStartingNumber, sendNotificationOnce.
Required sponsor roles are: clinical supply manager and site manager.
Rights: SupplySettingRightsPost.",
"operationId":"updateSupplySettings_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SupplySettingsTO"
},
"examples":{
"Update Supply Settings Request":{
"description":"Update Supply Settings Request",
"value":{
"useBlindingGroups":true,
"useLabelGroups":true,
"useShippingGroups":true,
"useTemperatureExcursion":false,
"allowSingleKitQuarantine":true,
"allowManualConsignments":false,
"singleKitSettingId":1,
"sendKitTypeForSingleKitOrder":"B1B8327AFAA6412287106192AB5984EF",
"intlShipmentTriggerId":2,
"intlShipmentVisitId":"C36A3197FDEE433FB5547EE83DE99E4B",
"waitDaysBeforeNotifying":7,
"shipmentPrefixType":"CUSTOM",
"customShipmentIdPrefix":"ORD",
"kitReconciliationRequired":true,
"reuseSealedKits":true,
"reuseOnlyLastVisitKkits":true,
"allowPartialDispensation":true,
"confirmDispensation":true,
"depotKitReconRequired":true,
"dispenseByLowestKitNumber":true,
"allowDoseHold":true,
"quarantineWithoutTempMonitor":false,
"randomizeWhenKitsAvailable":false,
"allKitsSelectedForRandomization":false,
"kitsSelectedForRandomization":[
"7F6D13B3A6D54F0C9D90A5C58E6B2F11",
"6A2D911A4E5E4D61B29A1CC73E5402AB"
],
"sendNotificationOnce":false,
"tempExcursionStartingNumber":"12,13"
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/IDResponseV1"
},
"examples":{
"Update Supply Settings Response":{
"description":"Update Supply Settings Response",
"value":{
"id":"B1B8327AFAA6412287106192AB5984EF"
}
}
}
}
}
},
"404":{
"description":"Not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid shipment OR Invalid Kit status OR One or more shipment are not in valid status OR Custom shipment prefix should be of length between 1 to 10 and contains only alphanumerics OR Invalid shipment prefix type.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v9.0-studies-{studyId}-{mode}-supply-settings-put",
"x-filename-id":"ec-ors-svc-rest-v9.0-studies-studyid-mode-supply-settings-put"
}
},
"/ec-ors-svc/rest/v9.0/studies/{studyId}/{mode}/subjects/{externalSubjectId}/dispensation-history":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get dispensation history"
],
"summary":"[Deprecated]: v9.0",
"description":"Deprecated: Retrieves dispensation history for a study, by subject and visit ID. This version includes additional fields: - userId
- originalKit
- titration
- inventoryStatusName
Rights: OrsSubjectVisitGet.",
"operationId":"getDispensationHistory_10",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"path",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"asofdate",
"in":"query",
"description":"Get data as of the given date",
"required":true,
"schema":{
"type":"string"
},
"example":"2026-03-01"
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationHistoryResponse"
}
},
"examples":{
"Dispensation History Response":{
"description":"Dispensation History Response",
"value":[
{
"kitNumber":1001,
"inventoryStatus":4,
"dispensationDate":"2026-02-21T06:30:00Z",
"inventoryId":"B1B8327AFAA6412287106192AB5984EF",
"packageTypeId":2,
"unitsPerKit":1,
"returnedUnits":0,
"missingUnits":0,
"balanceUnits":1,
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"lastModifiedDate":"2026-02-22T09:45:00Z",
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"trialSupplyType":"BOTTLE",
"conserved":false,
"instanceNumber":1,
"barcode":"1236",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"kitNumberUTF":"000AB123",
"inventoryStatusName":"Dispensed",
"userId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"titration":"maintain",
"originalKit":"Kit-345",
"lotId":"6A2D911A4E5E4D61B29A1CC73E5402AB",
"lotNumber":"mf1",
"originalLotNumber":"mf1",
"dosingInstruction":"once daily"
}
]
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Subject not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid parameters",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v9.0-studies-{studyId}-{mode}-subjects-{externalSubjectId}-dispensation-history-get",
"x-filename-id":"ec-ors-svc-rest-v9.0-studies-studyid-mode-subjects-externalsubjectid-dispensation-history-get"
}
},
"/ec-ors-svc/rest/v9.0/studies/{studyId}/{mode}/visits/subjectvisit":{
"get":{
"tags":[
"Randomization and Supplies/Visit APIs/Get visit by visit ID"
],
"summary":"[Deprecated]: v9.0",
"description":"Deprecated: Retrieves visit by visit ID. This is a new version of the API for adding additional attributes barcode, dispensationConfirmed for barcode. Rights: OrsSubjectVisitGet.",
"operationId":"getVisit_16",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"externalSubjectId",
"in":"query",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string"
},
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
{
"name":"visitId",
"in":"query",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"instanceNumber",
"in":"query",
"description":"Instance number for unscheduled visit.",
"schema":{
"type":"string"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV8"
},
"examples":{
"Get Visit Response":{
"description":"Get Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Visit for subject does not exist.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid subject",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Internal server error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v9.0-studies-{studyId}-{mode}-visits-subjectvisit-get",
"x-filename-id":"ec-ors-svc-rest-v9.0-studies-studyid-mode-visits-subjectvisit-get"
},
"post":{
"tags":[
"Randomization and Supplies/Visit APIs/Randomize a subject or dispense a kit during a visit"
],
"summary":"[Deprecated]: v9.0",
"description":"Deprecated: Randomize a subject and/or dispense kits during a randomization or dispensation visit. This version of the API includes additional attributes for barcodes and dispensationConfirmed. Rights: OrsVisitManagementPost.",
"operationId":"visit_15",
"parameters":[
{
"name":"mode",
"in":"path",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"required":true,
"schema":{
"type":"string"
},
"example":"test"
},
{
"name":"studyId",
"in":"path",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitRequestV7"
},
"examples":{
"Visit Request":{
"description":"Visit Request",
"value":{
"subjectId":"C36A3197FDEE433FB5547EE83DE99E4B",
"siteId":"89EE76326E984B548D594D592E5C7FC2",
"visitId":"B1B8327AFAA6412287106192AB5984EF",
"studyVersion":"1.0.0.5",
"visitTimestamp":"2026-03-01 08:30:00",
"instanceNumber":1
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitResultV8"
},
"examples":{
"Visit Response":{
"description":"Visit Response",
"value":{
"randomNumber":"10",
"kits":[
{
"id":2,
"kitDescription":"Kit A",
"dose":5,
"measurement":"ml",
"frequency":"BID",
"consumeAcrossDoses":true,
"inventoryId":"D313327EF13845169A8ADADDA435431E",
"trialSupplyType":"BOTTLE",
"conserved":true,
"barcode":"1000",
"dispensationConfirmed":true,
"dosingUnblinded":false,
"titrationOption":"maintain"
}
],
"visitTimestamp":"2026-03-01T08:30:00Z",
"treatmentTitle":"A"
}
}
}
}
}
},
"404":{
"description":"Invalid study ID or version OR Rand List not found OR Design not found",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Not Found":{
"description":"Not Found",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"NOT_FOUND",
"errorMessage":"Resource not found.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"400":{
"description":"Invalid visit timestamp OR You must associate the randomization design with a visit before you can create/upload a randomization list for it OR The next step in this visit isn???t allowed for subject because the study version at your site isn???t compatible with the subject OR Subject can't be Re-randomized before randomization OR This operation is not allowed in the current subject status",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Bad Request":{
"description":"Bad Request",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"INVALID_REQUEST",
"errorMessage":"The request is invalid.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
},
"500":{
"description":"Unsupported Visit OR Subject already completed the visit OR Subject is randomized in error OR Invalid treatment found for the subject OR Visit out of order OR This operation is not allowed in the current subject status OR Visit is outside visit window OR Visit is outside visit window and at least one kit is configured not to dispense outside visit window OR Not enough inventory.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ORSResponse"
},
"examples":{
"Server Error":{
"description":"Server Error",
"value":{
"status":"error",
"result":null,
"errorData":{
"errorCode":"SERVER_ERROR",
"errorMessage":"Unexpected error occurred.",
"details":{
"reason":"See the error message for more information."
}
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-ors-svc-rest-v9.0-studies-{studyId}-{mode}-visits-subjectvisit-post",
"x-filename-id":"ec-ors-svc-rest-v9.0-studies-studyid-mode-visits-subjectvisit-post"
}
},
"/ec-rule-designer-svc/rest/v1.0/rulemgt/studies/{studyId}/{ruleId}/rulehistory":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule history by study ID, ruleid and optionally study mode"
],
"summary":"v1.0",
"description":"Retrieves the audit history of a given rule, including state, validation outcome, and author details. Compared to the legacy v0.9 endpoint, v1.0 introduces the optional `modes` filter and returns the origin channel metadata for each revision.",
"operationId":"getRuleHistoryByRuleIdV1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"example":"36753A48BBA048CB98A5F3278146118D"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"ruleId",
"in":"path",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
},
{
"name":"modes",
"in":"query",
"description":"Required list of study modes to filter the response. Allowed values: design, test, training, active.",
"required":true,
"schema":{
"type":"array",
"description":"Required list of study modes to filter the history results.",
"items":{
"maxLength":8,
"minLength":4,
"type":"string",
"description":"Study mode to include in the history response. Allowed values: design, test, training, or active.",
"example":"design",
"enum":[
"design",
"test",
"training",
"active"
]
}
},
"example":[
"design",
"test"
]
}
],
"responses":{
"200":{
"description":"Returned when rule history records are found for the supplied identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleHistoryResponseDoc"
},
"examples":{
"RuleHistory":{
"description":"RuleHistory",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleRevisionNumber":3,
"ruleDeleted":0,
"ruleEnabled":1,
"ruleName":"Visit Start Date Validation",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleDescription":"Validates that visit start date is not later than expected window.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule evaluated successfully.",
"ruleOriginType":"UI",
"versionStart":"2025-09-07T19:12:08Z",
"versionEnd":null,
"userId":"0000000000000000000000000000000A",
"userName":"jsmith",
"studyId":"36753A48BBA048CB98A5F3278146118D",
"studyversion":"3.2.0.18",
"studymode":"test"
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied identifiers fail validation or the query parameters are malformed.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestErrorDataDTO"
},
"examples":{
"RuleHistoryBadRequest":{
"description":"RuleHistoryBadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"204":{
"description":"Returned when no history entries exist for the supplied rule identifier and study context.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestErrorDataDTO"
},
"examples":{
"RuleHistoryNotFound":{
"description":"RuleHistoryNotFound",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when the rule history retrieval encounters an unexpected server-side error.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestErrorDataDTO"
},
"examples":{
"RuleHistoryServerError":{
"description":"RuleHistoryServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rulemgt-studies-{studyId}-{ruleId}-rulehistory-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rulemgt-studies-studyid-ruleid-rulehistory-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rulemgt/studies/{studyId}/{mode}/filteredlist":{
"post":{
"tags":[
"Rule Designer/Rule Management/Get all rules based on filter parameters"
],
"summary":"v1.0",
"description":"Retrieves rule management summaries by applying form, question, state, enabled, or validation filters. Multiple filters can be combined and the request body example illustrates supported fields and pagination controls. Compared to the v0.9 legacy endpoint, v1.0 introduces server-side pagination and explicit sort ordering to reduce payload sizes.",
"operationId":"filterRulesByStudyAndModeV1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-F]{32}$|^[0-9A-F]{8}-[0-9A-F]{4}-[0-9A-F]{4}-[0-9A-F]{4}-[0-9A-F]{12}$",
"type":"string",
"format":"uuid",
"example":"36753A48BBA048CB98A5F3278146118D"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Filtered lists payload \n (one or multiple parameter)",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleMgmtFilterDTO"
},
"examples":{
"BulkRuleFilterRequest":{
"description":"BulkRuleFilterRequest",
"value":{
"formId":"39903D6C-042D-4D9E-8977-3160488E6D3D",
"userId":"0000000000000000000000000000000A",
"userName":"jsmith",
"itemId":[
"2F4F4E67-E0CE-4BE0-BB95-44D2CD38A569"
],
"ruleState":[
"approved",
"publish"
],
"ruleEnabled":"1",
"publishRun":"AllData",
"ruleTrainingEnabled":"false",
"sortColumn":"ruleName",
"sortOrder":"ASC"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleMgmtFilterResponseDoc"
},
"examples":{
"BulkRuleFilterSuccess":{
"description":"BulkRuleFilterSuccess",
"value":{
"hasMore":false,
"totalResults":2,
"count":2,
"limit":50,
"offset":0,
"resultData":[
{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleOrder":10,
"ruleDeleted":0,
"ruleEnabled":1,
"ruleName":"Out of Range Visit Date",
"ruleRefName":"VISIT_DATE_RANGE_VALIDATION",
"ruleDescription":"Creates a query when visit date falls outside the allowable window.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule evaluated successfully.",
"ruleOriginType":"UI",
"ruleActionTypeName":"CREATE_QUERY",
"ruleEverInProduction":"false",
"ruleActionTarget":"VISIT",
"publishRun":"AllData",
"versionStart":"2025-09-07T19:12:08Z",
"versionEnd":null,
"lastModifiedDate":"2025-11-02T14:45:22Z",
"formName":"Screening Visit",
"questionName":"Visit Date",
"formRefName":"SCR_VISIT",
"questionRefName":"VISIT_DATE",
"userId":"0000000000000000000000000000000A",
"userName":"jsmith",
"ruleTrainingEnabled":"false"
}
]
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleMgmtErrorDoc"
},
"examples":{
"BulkRuleFilterValidationError":{
"description":"BulkRuleFilterValidationError",
"value":{
"status":"failed",
"result":"No result returned because the request failed validation.",
"errorCode":"JSON-004",
"errorMessage":"Invalid UUID list. One or more elements are invalid. Must contain at least one element.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleMgmtErrorDoc"
},
"examples":{
"BulkRuleFilterServerError":{
"description":"BulkRuleFilterServerError",
"value":{
"status":"failed",
"result":"No result returned because the request failed.",
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rulemgt-studies-{studyId}-{mode}-filteredlist-post",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rulemgt-studies-studyid-mode-filteredlist-post"
}
},
"/ec-rule-designer-svc/rest/v1.0/rulemgt/studies/{studyId}/{mode}/{publishRun}":{
"put":{
"tags":[
"Rule Designer/Rule Management/Allow rules to run on either All or Future data"
],
"summary":"v1.0",
"description":"Updates rules in a study to execute, when published, for either all or future data only. Compared to the v0.9 endpoint, v1.0 centralizes the publish scope in the path parameter and validates rule identifiers before applying changes.",
"operationId":"updatePublishRunForRulesV1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-F]{32}$|^[0-9A-F]{8}-[0-9A-F]{4}-[0-9A-F]{4}-[0-9A-F]{4}-[0-9A-F]{12}$",
"type":"string",
"format":"uuid",
"example":"36753A48BBA048CB98A5F3278146118D"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"publishRun",
"in":"path",
"description":"`AllData` republishes rules for existing and future subject data, while `FutureData` restricts the change to newly collected data.",
"required":true,
"schema":{
"maxLength":9,
"minLength":8,
"pattern":"AllData|FutureData",
"type":"string",
"example":"AllData",
"enum":[
"AllData",
"FutureData"
]
},
"example":"AllData"
}
],
"requestBody":{
"description":"Collection of rule identifiers included in the request. Each identifier accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleIdsDTO"
},
"examples":{
"PublishRunRequest":{
"description":"PublishRunRequest",
"value":{
"ruleIds":[
"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"938D23FA6B7241CCA41BD627E5DB60DA"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Rule enable/disable was successful.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/BulkRulePublishRunResponseItemDoc"
}
},
"examples":{
"PublishRunSuccess":{
"description":"PublishRunSuccess",
"value":[
{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Out of Range Visit Date",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":"Publish run updated to AllData"
},
"error":{
"status":"failed",
"result":"Validation failed",
"errorCode":"RuleSvc-021",
"errorMessage":"Issue in BulkExecuteRule API triggering",
"details":"Rule update failed validation."
}
}
]
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/BulkRulePublishRunResponseItemDoc"
}
},
"examples":{
"PublishRunValidationError":{
"description":"PublishRunValidationError",
"value":[
{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Out of Range Visit Date",
"jobStatus":"Failed",
"ruleValidationMessage":"Payload must include at least one ruleId.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":{
"status":"failed",
"result":"Validation failed"
},
"error":{
"status":"failed",
"result":"Validation failed",
"errorCode":"JSON-004",
"errorMessage":"Invalid UUID list. One or more elements are invalid. Must contain at least one element.",
"details":null
}
}
]
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/BulkRulePublishRunResponseItemDoc"
}
},
"examples":{
"PublishRunServerError":{
"description":"PublishRunServerError",
"value":[
{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Out of Range Visit Date",
"jobStatus":"Error",
"ruleValidationMessage":"Unexpected error while updating publish run.",
"ruleValidationStatus":false,
"httpErrorCode":500,
"httpErrorMessage":"Internal Server Error",
"result":{
"status":"error",
"result":"Processing failed"
},
"error":{
"status":"failed",
"result":"Processing failed",
"errorCode":"RuleSvc-021",
"errorMessage":"Issue in BulkExecuteRule API triggering",
"details":null
}
}
]
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rulemgt-studies-{studyId}-{mode}-{publishRun}-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rulemgt-studies-studyid-mode-publishrun-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/studies/{studyId}/{mode}/report/{reportName}":{
"post":{
"tags":[
"Rule Designer/Reporting/Generate Rule Designer reports"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Generates Rule Designer reports using the original column mapping. Compared to the preview implementation, this version standardizes pagination and validates supplied filters against the v1 schema. Upgrade to version 5.0 or later to access the expanded report schemas and audit metadata.",
"operationId":"generateReport",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"reportName",
"in":"path",
"description":"Report Name",
"required":true,
"schema":{
"type":"string"
},
"example":"RuleExecutionSummary"
}
],
"requestBody":{
"description":"Report Search Specs",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"ReportSearchSpecs":{
"summary":"Filter reports for approved rules",
"description":"ReportSearchSpecs",
"value":{
"limit":25,
"offset":0,
"fieldSpecsList":[
{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved",
"publish"
]
},
{
"fieldName":"ruleEnabled",
"fieldType":"list",
"fieldSequence":2,
"fieldValueList":[
"1"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportSuccess":{
"summary":"Sample paginated report response",
"description":"ReportSuccess",
"value":{
"hasMore":"false",
"totalResults":2,
"count":2,
"limit":25,
"offset":0,
"columns":[
"ruleId",
"ruleName",
"ruleState",
"ruleEnabled",
"studyMode"
],
"data":[
[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved",
"1",
"test"
],
[
"90C7669C40BF4371B71E8EB26851B8AD",
"Overdue Signature Reminder",
"publish",
"1",
"production"
]
]
}
}
}
}
}
},
"400":{
"description":"Invalid search specification. Returned when the request body omits required filters or supplies unsupported field names or data types.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportRequestInvalid":{
"summary":"Invalid filters supplied",
"description":"ReportRequestInvalid",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
},
"500":{
"description":"Unexpected processing failure while compiling the report results. Indicates a downstream data-service error or database issue.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportServerError":{
"summary":"Unexpected error executing report",
"description":"ReportServerError",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-studies-{studyId}-{mode}-report-{reportName}-post",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-studies-studyid-mode-report-reportname-post"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/delete/form/{formId}":{
"put":{
"tags":[
"Rule Designer/Rule Management/Delete UI rules by form ID"
],
"summary":"v1.0",
"description":"Removes UI rules by form ID.",
"operationId":"DeleteFormRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"formId",
"in":"path",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"38891F5E75BB4071BBF8ACE1F43BD1BD"
}
],
"responses":{
"200":{
"description":"Delete UI rules per form was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Success":{
"description":"Success",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-delete-form-{formId}-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-delete-form-formid-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/bulkdelete":{
"put":{
"tags":[
"Rule Designer/Rule Management/Delete rules in bulk"
],
"summary":"v1.0",
"description":"Removes rules in bulk.",
"operationId":"DeleteRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Bulk State Rules object.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleIdsDTO"
},
"examples":{
"BulkRuleDeleteRequest":{
"summary":"List of rule IDs to delete",
"description":"BulkRuleDeleteRequest",
"value":{
"ruleIds":[
"938D23FA6B7241CCA41BD627E5DB60DA"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk delete rules was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Success":{
"description":"Success",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-bulkdelete-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-bulkdelete-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/{ruleStatus}":{
"put":{
"tags":[
"Rule Designer/Rule Management/Enable or disable rule"
],
"summary":"v1.0",
"description":"Enables or disables rules in a study in Testing, Training or Production mode.",
"operationId":"EnableDisableRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleStatus",
"in":"path",
"description":"Action applied to the targeted rules. Allowed values: enable (set ruleEnabled to 1) or disable (set ruleEnabled to 0).",
"required":true,
"schema":{
"pattern":"enable|disable",
"type":"string",
"description":"Requested action to apply to the rules. Allowed values: enable, disable.",
"example":"enable",
"enum":[
"enable",
"disable"
]
},
"example":"enable"
}
],
"requestBody":{
"description":"Collection of rule identifiers included in the request. Each identifier accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleIdsDTO"
},
"examples":{
"EnableDisableRequest":{
"summary":"List of rule IDs to enable or disable",
"description":"EnableDisableRequest",
"value":{
"ruleIds":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Rule enable/disable was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"RulesListDTO":{
"summary":"RulesListDTOExample",
"description":"RulesListDTO",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-{ruleStatus}-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-rulestatus-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/simple":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get all rules based on given parameters"
],
"summary":"v1.0",
"description":"Retrieves the list of rules based on parameters such as form ID, item ID, property type, and rule name. Compared to the preview v0.9 API, v1.0 validates UUID filters, returns normalized action metadata, and limits responses to the requested study mode for UI consumption.",
"operationId":"GetAllRulesBy",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string"
},
"example":"39903D6C042D4D9E89773160488E6D3D"
},
{
"name":"ruleId",
"in":"query",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
},
{
"name":"ruleName",
"in":"query",
"description":"Optional rule name filter. Provide the user-facing title assigned to the rule.",
"schema":{
"type":"string",
"example":"Visit Start Date Validation"
},
"example":"Visit Start Date Validation"
},
{
"name":"propertyName",
"in":"query",
"description":"Optional property name filter used together with propertyType and eventId to resolve visit metadata.",
"schema":{
"type":"string",
"example":"visitStartDate"
},
"example":"visitStartDate"
},
{
"name":"propertyType",
"in":"query",
"description":"Optional property type filter used with propertyName and eventId. Allowed values: visit (filters by visit definition), event (limits results to a specific event), form (targets form-level attributes), item (targets a single item operand or action), and none (returns all property types).",
"schema":{
"type":"string",
"example":"visit",
"enum":[
"visit",
"event",
"form",
"item",
"none"
]
},
"example":"visit"
},
{
"name":"eventId",
"in":"query",
"description":"Optional event identifier. When supplied, responses include rules bound to the given event or unbound rules.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"itemId",
"in":"query",
"description":"Optional item identifier. Helps locate rules where the item is either an operand or the action target.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string"
},
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSimpleListDoc"
},
"examples":{
"RulesSimpleSuccess":{
"description":"RulesSimpleSuccess",
"value":{
"rules":[
{
"ruleId":"699EF3745FC545589F186D2198F3C65E",
"ruleName":"Query on negative temperature",
"ruleDescription":"Creates a query when body temperature is outside accepted range.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesSimpleBadRequest":{
"description":"RulesSimpleBadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesSimpleServerError":{
"description":"RulesSimpleServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-simple-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-simple-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/form/{formId}/valid":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get valid and enabled rules by form ID"
],
"summary":"v1.0",
"description":"Retrieves a list of rules which are in both valid and enabled states that belong to a given form.",
"operationId":"GetRulesByForm",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"formId",
"in":"path",
"description":"Optional item identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"39903D6C042D4D9E89773160488E6D3D"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesListDTO":{
"summary":"RulesListDTOExample",
"description":"RulesListDTO",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-form-{formId}-valid-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-form-formid-valid-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/form/{formId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by form ID"
],
"summary":"v1.0",
"description":"Retrieves every rule attached to the supplied form, including associated actions, operands, and validation details. Supports optional study version, event, and item filters to narrow the response. Compared to the legacy v0.9 endpoint, v1.0 returns normalized action metadata and enforces UUID validation for all identifiers.",
"operationId":"listRulesByFormV1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"example":"36753A48BBA048CB98A5F3278146118D"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"formId",
"in":"path",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"example":"39903D6C042D4D9E89773160488E6D3D"
},
"example":"39903D6C042D4D9E89773160488E6D3D"
},
{
"name":"ruleValidationStatus",
"in":"query",
"description":"Optional rule validation status filter. Accepted values: true (latest validation passed) or false (rule has validation errors).",
"schema":{
"type":"string",
"example":"true",
"enum":[
"true",
"false"
]
},
"example":true
},
{
"name":"ruleEnabled",
"in":"query",
"description":"Optional rule enabled filter. Accepted values: 1 (rule executes in the selected mode) or 0 (rule is disabled).",
"schema":{
"maximum":1,
"minimum":0,
"type":"integer",
"format":"int64",
"example":0,
"enum":[
0,
1
]
},
"example":0
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByFormSuccess":{
"description":"RulesByFormSuccess",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByFormBadRequest":{
"description":"RulesByFormBadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByFormServerError":{
"description":"RulesByFormServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-form-{formId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-form-formid-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/item/{itemId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by item ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of rules and related actions that belong to an item. Version 1.0 omits the operand metadata normalization introduced in versions 2.0 and 3.0.",
"operationId":"GetRulesByItem",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"example":"36753A48BBA048CB98A5F3278146118D"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"itemId",
"in":"path",
"description":"Optional item identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
},
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
},
{
"name":"studyVersion",
"in":"query",
"description":"Optional study version retained for backward compatibility.",
"schema":{
"type":"string",
"example":"3.2.0.18"
},
"example":"3.2.0.18"
},
{
"name":"eventId",
"in":"query",
"description":"Optional clinical event identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"nullable":true,
"example":"9B4AA96F48344015A259D6436EB97B47"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid",
"nullable":true,
"example":"39903D6C042D4D9E89773160488E6D3D"
},
"example":"39903D6C042D4D9E89773160488E6D3D"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByItemSuccess":{
"description":"RulesByItemSuccess",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByItemBadRequest":{
"description":"RulesByItemBadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByItemServerError":{
"description":"RulesByItemServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-item-{itemId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-item-itemid-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/propertyType/{propertyType}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by property"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of rules and related actions based on a property. Version 1.0 does not expose the property metadata normalization introduced in versions 2.0 and 3.0.",
"operationId":"GetRulesByProperty",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"propertyType",
"in":"path",
"description":"Optional property type filter aligned with RuleDesignerPropertyTypeEnum (visit, event, form, item, none).",
"required":true,
"schema":{
"type":"string",
"enum":[
"visit",
"event",
"form",
"item",
"none"
]
},
"example":"visit"
},
{
"name":"propertyName",
"in":"query",
"description":"Optional property name filter that works with propertyType to locate the visit attribute.",
"required":true,
"schema":{
"type":"string"
},
"example":"visitStartDate"
},
{
"name":"eventId",
"in":"query",
"description":"Optional event identifier retained for backward compatibility.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"eventInstanceNumber",
"in":"query",
"description":"Optional event instance number retained for backward compatibility. Provide a non-negative integer.",
"schema":{
"minimum":0,
"type":"number",
"format":"double"
},
"example":1
},
{
"name":"studyVersion",
"in":"query",
"description":"Optional study version retained for backward compatibility.",
"schema":{
"type":"string"
},
"example":"3.2.0.18"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier retained for backward compatibility.",
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"39903D6C042D4D9E89773160488E6D3D"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByPropertySuccess":{
"description":"RulesByPropertySuccess",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByPropertyBadRequest":{
"description":"RulesByPropertyBadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByPropertyServerError":{
"description":"RulesByPropertyServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-propertyType-{propertyType}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-propertytype-propertytype-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rules by study ID and study mode"
],
"summary":"v1.0",
"description":"Retrieves a list of rules and related actions that belong to a specified study ID and mode. Compared to the legacy v0.9 endpoint, v1.0 normalizes rule payload metadata, enforces UUID validation for all identifiers, and blocks design-mode queries that previously returned partial results.",
"operationId":"GetRulesByStudyMode",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleValidationStatus",
"in":"query",
"description":"Rule validation status flag. Allowed values: true (latest validation passed) or false (validation failed).",
"schema":{
"type":"string",
"enum":[
"true",
"false"
]
},
"example":true
},
{
"name":"ruleEnabled",
"in":"query",
"description":"Rule enabled flag. Allowed values: 1 (enabled) or 0 (disabled) for the selected study mode.",
"schema":{
"maximum":1,
"minimum":0,
"type":"integer",
"format":"int64",
"enum":[
0,
1
]
},
"example":0
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByStudyModeSuccess":{
"description":"RulesByStudyModeSuccess",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByStudyModeBadRequest":{
"description":"RulesByStudyModeBadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByStudyModeServerError":{
"description":"RulesByStudyModeServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/publish":{
"put":{
"tags":[
"Rule Designer/Rule Management/Publish a collection of rules in Testing mode"
],
"summary":"v1.0",
"description":"Publishes a collection of rules in a study, while in Testing mode.",
"operationId":"PublishRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"reExecuteRules",
"in":"query",
"description":"Re-execute Rules.",
"schema":{
"type":"boolean"
},
"example":true
}
],
"requestBody":{
"description":"Collection of rule identifiers included in the request. Each identifier accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleIdsDTO"
},
"examples":{
"PublishRulesRequest":{
"summary":"List of rule IDs to publish",
"description":"PublishRulesRequest",
"value":{
"ruleIds":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Rule published successfully.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Success":{
"description":"Success",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-publish-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-publish-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/bulkupdate":{
"put":{
"tags":[
"Rule Designer/Rule Management/Update rules in bulk"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Updates multiple rules within a study in a single transaction. Each rule entry must specify operands, actions, and the desired enabled state. Requests are validated against the supplied study mode (design or test) before any persistence changes are committed. Version 1.0 relies on the legacy synchronous engine and does not provide the performance optimizations or job identifier tracking added in versions 6.0 and 7.0.",
"operationId":"UpdateRulesBulk",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Bulk Rules object.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkUpdateRulesDTO"
},
"examples":{
"BulkUpdateRulesRequest":{
"summary":"Example bulk rule update payload",
"description":"BulkUpdateRulesRequest",
"value":{
"rules":[
{
"ruleId":"938D23FA6B7241CCA41BD627E5DB60DA",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleExpression":"var1 != null",
"studyVersion":"3.2.0.18",
"ruleEnabled":1,
"ruleDeleted":0,
"ruleName":"Visit Start Date Validation",
"ruleJSExpression":"var1 != null",
"ruleVersionNumber":3,
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"user rule",
"actions":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"ruleActionTypeName":"auto query",
"ruleActionOrder":1,
"ruleActionDescription":"Open a query when validation fails.",
"ruleActionParams":"Please verify visit start date."
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"(Optional)eventInstanceNumber":1,
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"propertyType":"visit",
"propertyName":"visitStartDate",
"operandName":"var1",
"dataType":"Text",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE"
}
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk rule update was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Success":{
"description":"Success",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-bulkupdate-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-bulkupdate-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/bulkcopy":{
"put":{
"tags":[
"Rule Designer/Rule Management/Copy rules in bulk"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Copies rules in bulk. Version 1.0 executes the legacy synchronous copy flow and omits the asynchronous job status metadata introduced in versions 2.0 and 3.0.",
"operationId":"copyFormRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
}
],
"requestBody":{
"description":"Bulk State Rules object.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleCopyDTO"
},
"examples":{
"BulkCopyRequest":{
"summary":"Example bulk copy payload",
"description":"BulkCopyRequest",
"value":{
"studies":[
{
"fromStudyId":"82A65F8F6AAF47FFB177662E3931E7C0",
"fromStudyVersion":"1.0.0.0",
"toStudyId":"7B0D4823F4BE4E0FB86E0D593421C1A9",
"toStudyVersion":"1.0.0.0",
"forms":[
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk delete rules was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Success":{
"description":"Success",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-bulkcopy-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-bulkcopy-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/copyrules":{
"post":{
"tags":[
"Rule Designer/Rule Management/Copy Rules to newly copied study"
],
"summary":"v1.0",
"description":"Copies all active rules from specified source study to specified target study.",
"operationId":"copyRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
}
],
"requestBody":{
"description":"Study Map object.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyMapDTO"
},
"examples":{
"CopyRulesRequest":{
"summary":"Example mapping payload",
"description":"CopyRulesRequest",
"value":{
"fromStudyId":"82A65F8F6AAF47FFB177662E3931E7C0",
"fromStudyVersion":"1.0.0.0",
"toStudyId":"7B0D4823F4BE4E0FB86E0D593421C1A9",
"toStudyVersion":"1.0.0.0",
"forms":[
]
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Validation request accepted and processing started asynchronously.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Accepted":{
"description":"Accepted",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Queued",
"ruleValidationMessage":"Copy request accepted for asynchronous processing.",
"ruleValidationStatus":true,
"result":{
"status":"success",
"result":{
"message":"Copy request accepted for asynchronous processing."
}
},
"error":null,
"httpErrorCode":202,
"httpErrorMessage":"Accepted"
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-copyrules-post",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-copyrules-post"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/disableAllNotificationRules":{
"put":{
"tags":[
"Rule Designer/Rule Management/Disable all notification rules"
],
"summary":"v1.0",
"description":"Disables all notification rules for a given study. The rules in all the study modes are disabled.",
"operationId":"disableAllNotificationRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
}
],
"responses":{
"200":{
"description":"Rule copy was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"Success":{
"description":"Success",
"value":{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestErrorDataDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-disableAllNotificationRules-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-disableallnotificationrules-put"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/versions/{version}/formId/{formId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get visits and forms action information."
],
"summary":"v1.0",
"description":"Retrieves information about visits/forms related actions.",
"operationId":"getActionVisitsForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"version",
"in":"path",
"description":"Optional study version value. Provide the semantic version string that uniquely identifies the study draft.",
"required":true,
"schema":{
"type":"string"
},
"example":"3.2.0.18"
},
{
"name":"formId",
"in":"path",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"38891F5E75BB4071BBF8ACE1F43BD1BD"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
}
},
"examples":{
"RulesListDTO":{
"summary":"RulesListDTOExample",
"description":"RulesListDTO",
"value":[
{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
]
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-versions-{version}-formId-{formId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-versions-version-formid-formid-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/ruleId/{ruleId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by rule ID"
],
"summary":"[Deprecated]: v1.0",
"description":"Deprecated: Use latest version instead. Retrieves the rule identified by the supplied rule ID, returning full metadata, operands, actions, and validation state so clients can render the rule editor. Version 1.0 omits the execution summary and job tracking metadata provided from version 5.0 onward.",
"operationId":"getRulesById",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleId",
"in":"path",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
}
},
"examples":{
"Success":{
"description":"Success",
"value":[
{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
]
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-ruleId-{ruleId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-ruleid-ruleid-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/ruleIds/operands":{
"post":{
"tags":[
"Rule Designer/Rule Management/Get rule Operands list by rule IDs"
],
"summary":"v1.0",
"description":"Retrieves the rule operands that belong to a specified rule IDs.",
"operationId":"getRulesByIds",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"List of Rule IDs.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleIDsReq"
},
"examples":{
"RuleIdsRequest":{
"summary":"List of rule IDs to fetch operands",
"description":"RuleIdsRequest",
"value":{
"ruleIds":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
}
},
"examples":{
"Success":{
"description":"Success",
"value":[
{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
]
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-ruleIds-operands-post",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-ruleids-operands-post"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/rulenames":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get multiple parameters of all rules in a study"
],
"summary":"v1.0",
"description":"Retrieves the following data for all rules: name, ID, rulerefname, ruleState, ruleDeleted, ruleEnabled, ruleValidationStatus and studymode for a given study ID and mode. Allows optional filters such as ruleState, ruleDeleted, ruleEnabled, and ruleValidationStatus.",
"operationId":"getRulesNameByMode",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleValidationStatus",
"in":"query",
"description":"Optional rule validation status filter. Accepted values: true (latest validation passed) or false (rule has validation errors).",
"schema":{
"type":"string",
"enum":[
"true",
"false"
]
},
"example":true
},
{
"name":"ruleEnabled",
"in":"query",
"description":"Optional rule enabled filter. Accepted values: 1 (rule executes in the selected mode) or 0 (rule is disabled).",
"schema":{
"maximum":1,
"minimum":0,
"type":"integer",
"format":"int64",
"enum":[
0,
1
]
},
"example":0
},
{
"name":"ruleDeleted",
"in":"query",
"description":"Optional rule deleted filter. Accepted values: 1 (rule marked deleted) or 0 (rule active).",
"schema":{
"maximum":1,
"minimum":0,
"type":"integer",
"format":"int64",
"enum":[
0,
1
]
},
"example":0
},
{
"name":"ruleState",
"in":"query",
"description":"Optional rule workflow state filter. Allowed values: draft (authoring), uat (in validation), approved (ready for release), publish (live in production).",
"schema":{
"type":"string",
"enum":[
"draft",
"uat",
"approved",
"publish"
]
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
}
},
"examples":{
"Bulk Update Rules Success Response":{
"summary":"Example response for a successful bulk update rules request",
"description":"Bulk Update Rules Success Response",
"value":[
{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
]
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-rulenames-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-rulenames-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/{mode}/rulestates":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get all rule states"
],
"summary":"v1.0",
"description":"Retrieves states of all rules by study ID and study mode (Testing, Training, or Production).",
"operationId":"ruleStates",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"example":"draft",
"enum":[
"draft",
"uat",
"approved",
"publish"
]
}
},
"examples":{
"Success":{
"description":"Success",
"value":[
"draft",
"uat",
"approved",
"publish"
]
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-{mode}-rulestates-get",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-mode-rulestates-get"
}
},
"/ec-rule-designer-svc/rest/v1.0/rule/studies/{studyId}/validateCopiedRules":{
"put":{
"tags":[
"Rule Designer/Rule Management/Validate copied rules"
],
"summary":"v1.0",
"description":"Validates copied rules during the initial draft-to-testing tile move. The optional request body accepts study title labels used in notification content: one title for the target study or two titles in order [sourceStudyTitle, targetStudyTitle].",
"operationId":"validateCopiedRulesDuringInitialDraftTileMove",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"studyVersion",
"in":"query",
"description":"Optional study version value. Provide the semantic version string that uniquely identifies the study draft.",
"schema":{
"type":"string"
},
"example":"3.2.0.18"
}
],
"requestBody":{
"description":"Optional array of study title labels used for copy-validation notifications. Provide one title (target study) or two titles in order [sourceStudyTitle, targetStudyTitle].",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"example":"Source Oncology Study"
}
},
"examples":{
"StudyTitles":{
"description":"StudyTitles",
"value":[
"Source Oncology Study",
"Target Oncology Study"
]
}
}
}
}
},
"responses":{
"202":{
"description":"Validation request accepted and processing started asynchronously.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"Accepted":{
"description":"Accepted",
"value":{
"status":"success",
"result":{
"message":"Copied Rule Validation In Progress"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestErrorDataDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-{studyId}-validateCopiedRules-put",
"x-filename-id":"ec-rule-designer-svc-rest-v1.0-rule-studies-studyid-validatecopiedrules-put"
}
},
"/ec-rule-designer-svc/rest/v2.0/studies/{studyId}/{mode}/report/{reportName}":{
"post":{
"tags":[
"Rule Designer/Reporting/Generate Rule Designer reports"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Use latest version instead. Generates Rule Designer reports using the v2 schema. Compared to v1.0, it accepts the additional filter keys defined in ReportColumnMappingV2 and enforces their expected data types. This benefits users by reducing failed report runs caused by malformed filter payloads. Later versions add expanded report schemas and audit metadata????????upgrade to version 5.0 or above.",
"operationId":"generateReport_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"reportName",
"in":"path",
"description":"Report Name",
"required":true,
"schema":{
"maxLength":128,
"minLength":3,
"type":"string"
},
"example":"RuleExecutionSummary"
}
],
"requestBody":{
"description":"Report Search Specs",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"ReportSearchSpecs":{
"summary":"Filter reports for approved rules",
"description":"ReportSearchSpecs",
"value":{
"limit":25,
"offset":0,
"fieldSpecsList":[
{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved",
"publish"
]
},
{
"fieldName":"ruleEnabled",
"fieldType":"list",
"fieldSequence":2,
"fieldValueList":[
"1"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportSuccess":{
"summary":"Sample paginated report response",
"description":"ReportSuccess",
"value":{
"hasMore":"false",
"totalResults":2,
"count":2,
"limit":25,
"offset":0,
"columns":[
"ruleId",
"ruleName",
"ruleState",
"ruleEnabled",
"studyMode"
],
"data":[
[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved",
"1",
"test"
],
[
"90C7669C40BF4371B71E8EB26851B8AD",
"Overdue Signature Reminder",
"publish",
"1",
"production"
]
]
}
}
}
}
}
},
"400":{
"description":"Invalid search specification. Returned when the request body omits required filters or supplies unsupported field names or data types.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportRequestInvalid":{
"summary":"Invalid filters supplied",
"description":"ReportRequestInvalid",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
},
"500":{
"description":"Unexpected processing failure while compiling the report results. Indicates a downstream data-service error or database issue.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportServerError":{
"summary":"Unexpected error executing report",
"description":"ReportServerError",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-studies-{studyId}-{mode}-report-{reportName}-post",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-studies-studyid-mode-report-reportname-post"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/{mode}/simple":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get all rules based on given parameters"
],
"summary":"v2.0",
"description":"Retrieves rule summaries with the extended filtering set introduced for the rule designer grid. Compared to v1.0, v2.0 adds pagination controls (offset, limit), grid layout toggles, server-side sorting, and advanced text filtering used by the redesigned workspace. This benefits users by making large rule sets faster to navigate and triage.",
"operationId":"GetAllRulesBy_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"39903D6C042D4D9E89773160488E6D3D"
},
{
"name":"ruleId",
"in":"query",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
},
{
"name":"ruleName",
"in":"query",
"description":"Optional rule name filter. Provide the user-facing title assigned to the rule.",
"schema":{
"maxLength":256,
"minLength":1,
"type":"string"
},
"example":"Visit Start Date Validation"
},
{
"name":"propertyName",
"in":"query",
"description":"Optional property name filter used together with propertyType and eventId to resolve visit metadata.",
"schema":{
"maxLength":128,
"minLength":1,
"type":"string"
},
"example":"visitStartDate"
},
{
"name":"propertyType",
"in":"query",
"description":"Optional property type filter used with propertyName and eventId. Allowed values: visit (filters by visit definition), event (limits results to a specific event), form (targets form-level attributes), item (targets a single item operand or action), and none (returns all property types).",
"schema":{
"maxLength":5,
"minLength":4,
"type":"string",
"enum":[
"visit",
"event",
"form",
"item",
"none"
]
},
"example":"visit"
},
{
"name":"eventId",
"in":"query",
"description":"Optional event identifier. When supplied, responses include rules bound to the given event or unbound rules.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"itemId",
"in":"query",
"description":"Optional item identifier. Helps locate rules where the item is either an operand or the action target.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
},
{
"name":"gridView",
"in":"query",
"description":"Optional UI layout selector. Allowed values: Grid (card layout) or List (tabular layout).",
"schema":{
"maxLength":16,
"minLength":2,
"type":"string"
},
"example":"Grid"
},
{
"name":"offset",
"in":"query",
"description":"Zero-based offset for pagination. Supply a non-negative integer.",
"schema":{
"minimum":0,
"type":"integer",
"format":"int32"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Page size for pagination. Supply an integer between 1 and 500.",
"schema":{
"maximum":500,
"minimum":1,
"type":"integer",
"format":"int32"
},
"example":50
},
{
"name":"sortColumn",
"in":"query",
"description":"Column name used for sorting (for example ruleName, ruleState). Provide 1 to 64 characters.",
"schema":{
"maxLength":64,
"minLength":1,
"type":"string"
},
"example":"ruleName"
},
{
"name":"sortOrder",
"in":"query",
"description":"Sort order for the selected column. Allowed values: ASC (ascending) or DESC (descending).",
"schema":{
"maxLength":4,
"minLength":3,
"type":"string",
"enum":[
"ASC",
"DESC"
]
},
"example":"ASC"
},
{
"name":"filterView",
"in":"query",
"description":"Optional named filter preset applied in the designer UI (for example Filter, Favorites). Provide up to 32 characters.",
"schema":{
"maxLength":32,
"minLength":1,
"type":"string"
},
"example":"Filter"
},
{
"name":"searchString",
"in":"query",
"description":"Optional keyword filter applied to rule names or descriptions. Provide 1 to 256 characters.",
"schema":{
"maxLength":256,
"minLength":1,
"type":"string"
},
"example":"visitStartDate"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSimpleListDoc"
},
"examples":{
"RulesSimpleListV2Success":{
"description":"RulesSimpleListV2Success",
"value":{
"rules":[
{
"ruleId":"699EF3745FC545589F186D2198F3C65E",
"ruleName":"Query on negative temperature",
"ruleDescription":"Creates a query when body temperature is outside accepted range.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesSimpleListV2BadRequest":{
"description":"RulesSimpleListV2BadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesSimpleListV2ServerError":{
"description":"RulesSimpleListV2ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-{mode}-simple-get",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-mode-simple-get"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/{mode}/item/{itemId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by item ID"
],
"summary":"v2.0",
"description":"Version 2.0 retrieves rules by item identifier with normalized operand metadata and UUID validation compared to version 1.0. This benefits users by reducing client-side data-shaping work when rendering item-level rule summaries.",
"operationId":"GetRulesByItem_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"itemId",
"in":"path",
"description":"Optional item identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
},
{
"name":"studyVersion",
"in":"query",
"description":"Optional study version retained for backward compatibility.",
"schema":{
"maxLength":32,
"minLength":1,
"type":"string"
},
"example":"3.2.0.18"
},
{
"name":"eventId",
"in":"query",
"description":"Optional clinical event identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"EACDC121885343B1B7EF452D49D96666"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByItemV2Success":{
"description":"RulesByItemV2Success",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByItemV2BadRequest":{
"description":"RulesByItemV2BadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByItemV2ServerError":{
"description":"RulesByItemV2ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-{mode}-item-{itemId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-mode-item-itemid-get"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/{mode}/propertyType/{propertyType}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by property"
],
"summary":"v2.0",
"description":"Version 2.0 retrieves rules by property type with normalized property metadata and UUID validation compared to version 1.0. This benefits users by producing consistent property-filter responses across study modes.",
"operationId":"GetRulesByProperty_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"propertyType",
"in":"path",
"description":"Optional property type filter aligned with RuleDesignerPropertyTypeEnum (visit, event, form, item, none).",
"required":true,
"schema":{
"maxLength":5,
"minLength":4,
"type":"string",
"enum":[
"visit",
"event",
"form",
"item",
"none"
]
},
"example":"visit"
},
{
"name":"propertyName",
"in":"query",
"description":"Optional property name filter that works with propertyType to locate the visit attribute.",
"required":true,
"schema":{
"maxLength":128,
"minLength":1,
"type":"string"
},
"example":"visitStartDate"
},
{
"name":"eventId",
"in":"query",
"description":"Optional event identifier retained for backward compatibility.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
},
{
"name":"eventInstanceNumber",
"in":"query",
"description":"Optional event instance number retained for backward compatibility. Provide a non-negative integer.",
"schema":{
"minimum":0,
"type":"number",
"format":"double"
},
"example":1
},
{
"name":"studyVersion",
"in":"query",
"description":"Optional study version retained for backward compatibility.",
"schema":{
"maxLength":32,
"minLength":1,
"type":"string"
},
"example":"3.2.0.18"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier retained for backward compatibility.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"valid",
"in":"query",
"description":"Optional flag that limits results to rules that currently validate successfully (true/false).",
"schema":{
"maxLength":5,
"minLength":4,
"type":"string",
"enum":[
"true",
"false"
]
},
"example":true
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByPropertyV2Success":{
"description":"RulesByPropertyV2Success",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByPropertyV2BadRequest":{
"description":"RulesByPropertyV2BadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByPropertyV2ServerError":{
"description":"RulesByPropertyV2ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-{mode}-propertyType-{propertyType}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-mode-propertytype-propertytype-get"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/{mode}/bulkupdate":{
"put":{
"tags":[
"Rule Designer/Rule Management/Update rules in bulk"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Use latest version instead. Updates multiple rules within a study in a single transaction. Each rule entry must specify operands, actions, and the desired enabled state. Requests are validated against the supplied study mode (design or test) before any persistence changes are committed. Compared to version 1.0, version 2.0 improves payload validation consistency for bulk updates. Version 2.0 predates the cached execution pipeline and asynchronous job identifiers available from version 6.0 onward. This benefits users by reducing avoidable validation mismatches in bulk-update requests.",
"operationId":"UpdateRulesBulk_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Request body containing information about all rules for which they need to created or updated",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkUpdateRulesDTOV3"
},
"examples":{
"BulkUpdateRulesDTOV3":{
"summary":"BulkUpdateRulesDTOV3Example",
"description":"BulkUpdateRulesDTOV3",
"value":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleName":"Visit Start Date Validation",
"ruleExpression":"if(var1 != null){ return true; } return false;",
"ruleJSExpression":"if(var1 != null){ return true; } return false;",
"ruleVersionNumber":3,
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginalType":"user rule",
"isLibrary":false,
"ruleEnabled":1,
"ruleDeleted":0,
"studyVersion":"3.2.0.18",
"actions":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"ruleActionTypeName":"auto query",
"ruleActionOrder":1,
"ruleActionDescription":"Open a query when validation fails.",
"ruleActionParams":"Please verify visit start date."
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"(Optional)eventInstanceNumber":1,
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"propertyType":"visit",
"propertyName":"visitStartDate",
"operandName":"var1",
"dataType":"Text",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE"
}
],
"async":0
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk rule update was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk Update Rules Success Response":{
"summary":"Example response for a successful bulk update rules request",
"description":"Bulk Update Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-{mode}-bulkupdate-put",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-mode-bulkupdate-put"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/bulkcopy":{
"put":{
"tags":[
"Rule Designer/Rule Management/Copy rules in bulk"
],
"summary":"v2.0",
"description":"Version 2.0 copies rules in bulk with stricter UUID validation and detailed error reporting compared to version 1.0, preparing clients for the asynchronous status tracking added in version 3.0. This benefits users by improving copy-request reliability before migrating to asynchronous flows.",
"operationId":"copyFormRules_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
}
],
"requestBody":{
"description":"Bulk State Rules object.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleCopyDTO"
},
"examples":{
"BulkCopyRequest":{
"summary":"Example bulk copy payload",
"description":"BulkCopyRequest",
"value":{
"studies":[
{
"fromStudyId":"82A65F8F6AAF47FFB177662E3931E7C0",
"fromStudyVersion":"1.0.0.0",
"toStudyId":"7B0D4823F4BE4E0FB86E0D593421C1A9",
"toStudyVersion":"1.0.0.0",
"forms":[
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk delete rules was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk copy Rules Success Response":{
"summary":"Example response for a successful bulk copy rules request",
"description":"Bulk copy Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-bulkcopy-put",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-bulkcopy-put"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/copyrules":{
"post":{
"tags":[
"Rule Designer/Rule Management/Copy Rules to newly copied study"
],
"summary":"v2.0",
"description":"Copies all active rules from the specified source study to the target study. Compared to v1.0, v2.0 records asynchronous job identifiers, validates new UUID conversion helpers, and supports the enhanced Audit payload returned by the designer service. This benefits users by providing deterministic tracking for cross-study copy operations.",
"operationId":"copyRules_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
}
],
"requestBody":{
"description":"Study Map object.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyMapDTOV3"
},
"examples":{
"CopyRulesRequest":{
"summary":"Example mapping payload",
"description":"CopyRulesRequest",
"value":{
"fromStudyId":"82A65F8F6AAF47FFB177662E3931E7C0",
"fromStudyVersion":"1.0.0.0",
"toStudyId":"7B0D4823F4BE4E0FB86E0D593421C1A9",
"toStudyVersion":"1.0.0.0",
"fromIsLibrary":false,
"toIsLibrary":false,
"isToIsLibrary":false,
"forms":[
]
}
}
}
}
},
"required":true
},
"responses":{
"202":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Accepted":{
"description":"Accepted",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-copyrules-post",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-copyrules-post"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/{mode}/ruleId/{ruleId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by rule ID"
],
"summary":"[Deprecated]: v2.0",
"description":"Deprecated: Use latest version instead. Retrieves the rule identified by the supplied rule ID, returning full metadata, operands, actions, and validation state so clients can render the rule editor. Compared to version 1.0, version 2.0 standardizes UUID validation and payload normalization for this endpoint. Version 2.0 predates the execution summary fields exposed from version 5.0 onward. This benefits users by providing more consistent rule-detail payloads for UI rendering.",
"operationId":"getRulesById_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleId",
"in":"path",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"Rule Details for given RuleId":{
"summary":"Example response for a successful rules request",
"description":"Rule Details for given RuleId",
"value":{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-{mode}-ruleId-{ruleId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-mode-ruleid-ruleid-get"
}
},
"/ec-rule-designer-svc/rest/v2.0/rule/studies/{studyId}/{mode}/ruleIds/operands":{
"post":{
"tags":[
"Rule Designer/Rule Management/Get rule Operands list by rule IDs"
],
"summary":"v2.0",
"description":"Retrieves the operands associated with each supplied rule identifier. Compared to v1.0, v2.0 returns operands grouped by ruleId, includes mapRelation metadata, and documents operand data types for the enhanced rule designer grid. This benefits users by reducing client-side parsing complexity for bulk operand rendering.",
"operationId":"getRulesByIds_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Request body containing list of all rules",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleIDsReq"
},
"examples":{
"RuleIDsReq":{
"summary":"RuleIDsReqExample",
"description":"RuleIDsReq",
"value":{
"ruleIds":[
"EACDC121885343B1B7EF452D49D96666",
"CDBAE5901A2D407A9DE6A53D70FC2488"
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"Operands details for list of rules Success Response":{
"summary":"Example list of operands response for a list of rules",
"description":"Operands details for list of rules Success Response",
"value":{
"status":"success",
"result":{
"cdbae590-1a2d-407a-9de6-a53d70fc2488":[
{
"eventId":null,
"eventInstanceNumber":null,
"formId":null,
"itemId":null,
"propertyType":null,
"propertyName":"visitStartDate",
"operandName":"input",
"dataType":"Date",
"eventRefName":null,
"formRefName":null,
"itemRefName":null,
"mapRelation":"N"
}
],
"eacdc121-8853-43b1-b7ef-452d49d96666":[
{
"eventId":null,
"eventInstanceNumber":null,
"formId":null,
"itemId":null,
"propertyType":null,
"propertyName":"visitStartDate",
"operandName":"dov",
"dataType":"Date",
"eventRefName":null,
"formRefName":null,
"itemRefName":null,
"mapRelation":"N"
},
{
"eventId":null,
"eventInstanceNumber":null,
"formId":"9B4AA96F48344015A259D6436EB97B47",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"propertyType":null,
"propertyName":null,
"operandName":"banana",
"dataType":"Text",
"eventRefName":null,
"formRefName":null,
"itemRefName":null,
"mapRelation":"N"
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-{studyId}-{mode}-ruleIds-operands-post",
"x-filename-id":"ec-rule-designer-svc-rest-v2.0-rule-studies-studyid-mode-ruleids-operands-post"
}
},
"/ec-rule-designer-svc/rest/v3.0/studies/{studyId}/{mode}/report/{reportName}":{
"post":{
"tags":[
"Rule Designer/Reporting/Generate Rule Designer reports"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Use latest version instead. Generates Rule Designer reports using the v3 schema. Compared to v2.0, it surfaces the action and operand reference columns introduced in ReportColumnMappingV3 and validates filters against those additions. This benefits users by exposing richer diagnostics in a single report export. Upgrade to version 5.0 or later for the audit metadata and instrument tracking columns delivered in more recent schemas.",
"operationId":"generateReport_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"reportName",
"in":"path",
"description":"Report Name",
"required":true,
"schema":{
"maxLength":128,
"minLength":3,
"type":"string"
},
"example":"RuleExecutionSummary"
}
],
"requestBody":{
"description":"Report Search Specs",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"ReportSearchSpecs":{
"summary":"Filter reports for approved rules",
"description":"ReportSearchSpecs",
"value":{
"limit":25,
"offset":0,
"fieldSpecsList":[
{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved",
"publish"
]
},
{
"fieldName":"ruleEnabled",
"fieldType":"list",
"fieldSequence":2,
"fieldValueList":[
"1"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportSuccess":{
"summary":"Sample paginated report response",
"description":"ReportSuccess",
"value":{
"hasMore":"false",
"totalResults":2,
"count":2,
"limit":25,
"offset":0,
"columns":[
"ruleId",
"ruleName",
"ruleState",
"ruleEnabled",
"studyMode"
],
"data":[
[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved",
"1",
"test"
],
[
"90C7669C40BF4371B71E8EB26851B8AD",
"Overdue Signature Reminder",
"publish",
"1",
"production"
]
]
}
}
}
}
}
},
"400":{
"description":"Invalid search specification. Returned when the request body omits required filters or supplies unsupported field names or data types.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportRequestInvalid":{
"summary":"Invalid filters supplied",
"description":"ReportRequestInvalid",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
},
"500":{
"description":"Unexpected processing failure while compiling the report results. Indicates a downstream data-service error or database issue.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportServerError":{
"summary":"Unexpected error executing report",
"description":"ReportServerError",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v3.0-studies-{studyId}-{mode}-report-{reportName}-post",
"x-filename-id":"ec-rule-designer-svc-rest-v3.0-studies-studyid-mode-report-reportname-post"
}
},
"/ec-rule-designer-svc/rest/v3.0/rule/studies/{studyId}/{mode}/item/{itemId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by item ID"
],
"summary":"v3.0",
"description":"Retrieves rules and related actions that belong to the specified item. Compared to v2.0, v3.0 adds the optional studyVersion filter so clients can inspect rules for a specific draft and returns the enhanced operand metadata introduced with the designer v3 DTO. This benefits users by enabling draft-specific troubleshooting without switching endpoints.",
"operationId":"GetRulesByItem_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"itemId",
"in":"path",
"description":"Optional item identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
},
{
"name":"studyVersion",
"in":"query",
"description":"Optional study version retained for backward compatibility.",
"schema":{
"maxLength":32,
"minLength":1,
"type":"string"
},
"example":"3.2.0.18"
},
{
"name":"eventId",
"in":"query",
"description":"Optional clinical event identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier filter. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"EACDC121885343B1B7EF452D49D96666"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByItemV3Success":{
"description":"RulesByItemV3Success",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByItemV3BadRequest":{
"description":"RulesByItemV3BadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByItemV3ServerError":{
"description":"RulesByItemV3ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-{studyId}-{mode}-item-{itemId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-studyid-mode-item-itemid-get"
}
},
"/ec-rule-designer-svc/rest/v3.0/rule/studies/{studyId}/{mode}/propertyType/{propertyType}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by property"
],
"summary":"v3.0",
"description":"Retrieves rules and actions based on visit property metadata. Compared to v2.0, v3.0 enables the studyVersion and validity filters so clients can isolate rules that passed the latest validation within a given draft. This benefits users by reducing noise when validating draft-specific rule quality.",
"operationId":"GetRulesByProperty_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"propertyType",
"in":"path",
"description":"Optional property type filter aligned with RuleDesignerPropertyTypeEnum (visit, event, form, item, none).",
"required":true,
"schema":{
"maxLength":5,
"minLength":4,
"type":"string",
"enum":[
"visit",
"event",
"form",
"item",
"none"
]
},
"example":"visit"
},
{
"name":"propertyName",
"in":"query",
"description":"Optional property name filter that works with propertyType to locate the visit attribute.",
"required":true,
"schema":{
"maxLength":128,
"minLength":1,
"type":"string"
},
"example":"visitStartDate"
},
{
"name":"eventId",
"in":"query",
"description":"Optional event identifier retained for backward compatibility.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"2F4F4E67E0CE4BE0BB9544D2CD38A569"
},
{
"name":"eventInstanceNumber",
"in":"query",
"description":"Optional event instance number retained for backward compatibility. Provide a non-negative integer.",
"schema":{
"minimum":0,
"type":"number",
"format":"double"
},
"example":1
},
{
"name":"studyVersion",
"in":"query",
"description":"Optional study version retained for backward compatibility.",
"schema":{
"maxLength":32,
"minLength":1,
"type":"string"
},
"example":"3.2.0.18"
},
{
"name":"formId",
"in":"query",
"description":"Optional form identifier retained for backward compatibility.",
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"9B4AA96F48344015A259D6436EB97B47"
},
{
"name":"valid",
"in":"query",
"description":"Optional flag that limits results to rules that currently validate successfully (true/false).",
"schema":{
"maxLength":5,
"minLength":4,
"type":"string",
"enum":[
"true",
"false"
]
},
"example":true
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryResponseDoc"
},
"examples":{
"RulesByPropertyV3Success":{
"description":"RulesByPropertyV3Success",
"value":{
"status":"success",
"result":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleName":"Visit Start Date Validation",
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginType":"UI",
"actions":[
{
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"ruleActionTypeName":"CREATE_QUERY",
"propertyType":"visit",
"propertyName":"visitStartDate",
"eventId":"9B4AA96F48344015A259D6436EB97B47"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"2F4F4E67E0CE4BE0BB9544D2CD38A569",
"mapRelation":"ANY"
}
]
}
]
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByPropertyV3BadRequest":{
"description":"RulesByPropertyV3BadRequest",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RuleSummaryErrorDoc"
},
"examples":{
"RulesByPropertyV3ServerError":{
"description":"RulesByPropertyV3ServerError",
"value":{
"status":"failed",
"result":null,
"errorCode":"RuleSvc-030",
"errorMessage":"Error encountered during rule execution. Contact your system administrator.",
"details":null
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-{studyId}-{mode}-propertyType-{propertyType}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-studyid-mode-propertytype-propertytype-get"
}
},
"/ec-rule-designer-svc/rest/v3.0/rule/studies/{studyId}/{mode}/bulkupdate":{
"put":{
"tags":[
"Rule Designer/Rule Management/Update rules in bulk"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Use latest version instead. Updates multiple rules within a study in a single transaction. Each rule entry must specify operands, actions, and the desired enabled state. Requests are validated against the supplied study mode (design or test) before any persistence changes are committed. Compared to version 2.0, version 3.0 aligns bulk-update processing with the v3 request model. Version 3.0 precedes the performance improvements and job identifier telemetry added in versions 6.0 and 7.0. This benefits users by improving consistency across v3 rule-management workflows.",
"operationId":"UpdateRulesBulk_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Request body containing information about all rules for which they need to created or updated",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkUpdateRulesDTOV3"
},
"examples":{
"BulkUpdateRulesDTOV3":{
"summary":"BulkUpdateRulesDTOV3Example",
"description":"BulkUpdateRulesDTOV3",
"value":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleName":"Visit Start Date Validation",
"ruleExpression":"if(var1 != null){ return true; } return false;",
"ruleJSExpression":"if(var1 != null){ return true; } return false;",
"ruleVersionNumber":3,
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginalType":"user rule",
"isLibrary":false,
"ruleEnabled":1,
"ruleDeleted":0,
"studyVersion":"3.2.0.18",
"actions":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"ruleActionTypeName":"auto query",
"ruleActionOrder":1,
"ruleActionDescription":"Open a query when validation fails.",
"ruleActionParams":"Please verify visit start date."
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"(Optional)eventInstanceNumber":1,
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"propertyType":"visit",
"propertyName":"visitStartDate",
"operandName":"var1",
"dataType":"Text",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE"
}
],
"async":0
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk rule update was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk Update Rules Success Response":{
"summary":"Example response for a successful bulk update rules request",
"description":"Bulk Update Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-{studyId}-{mode}-bulkupdate-put",
"x-filename-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-studyid-mode-bulkupdate-put"
}
},
"/ec-rule-designer-svc/rest/v3.0/rule/studies/{studyId}/bulkcopy":{
"put":{
"tags":[
"Rule Designer/Rule Management/Copy rules in bulk"
],
"summary":"v3.0",
"description":"Copies the supplied rules in bulk. Compared to v2.0, v3.0 records asynchronous job status in the response payload and normalizes the UUID formatting required by the rule designer service. This benefits users by enabling reliable progress tracking for long-running copy jobs.",
"operationId":"copyFormRules_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
}
],
"requestBody":{
"description":"Bulk State Rules object.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkRuleCopyDTOV3"
},
"examples":{
"BulkCopyRulesRequest":{
"description":"BulkCopyRulesRequest",
"value":{
"studies":[
{
"fromStudyId":"82A65F8F6AAF47FFB177662E3931E7C0",
"fromStudyVersion":"1.0.0.0",
"toStudyId":"7B0D4823F4BE4E0FB86E0D593421C1A9",
"toStudyVersion":"1.0.0.0",
"fromIsLibrary":false,
"toIsLibrary":false,
"isToIsLibrary":false,
"forms":[
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk delete rules was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk copy Rules Success Response":{
"summary":"Example response for a successful bulk copy rules request",
"description":"Bulk copy Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-{studyId}-bulkcopy-put",
"x-filename-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-studyid-bulkcopy-put"
}
},
"/ec-rule-designer-svc/rest/v3.0/rule/studies/{studyId}/{mode}/ruleId/{ruleId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by rule ID"
],
"summary":"[Deprecated]: v3.0",
"description":"Deprecated: Use latest version instead. Retrieves the rule identified by the supplied rule ID, returning full metadata, operands, actions, and validation state so clients can render the rule editor. Compared to version 2.0, version 3.0 aligns this endpoint with the v3 operand and study-version model. Version 3.0 does not surface the execution summary and job tracking details that arrive in version 5.0. This benefits users by keeping rule-detail behavior aligned with other v3 endpoints.",
"operationId":"getRulesById_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleId",
"in":"path",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"Rule Details for given RuleId":{
"summary":"Example response for a successful rules request",
"description":"Rule Details for given RuleId",
"value":{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-{studyId}-{mode}-ruleId-{ruleId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v3.0-rule-studies-studyid-mode-ruleid-ruleid-get"
}
},
"/ec-rule-designer-svc/rest/v4.0/studies/{studyId}/{mode}/report/{reportName}":{
"post":{
"tags":[
"Rule Designer/Reporting/Generate Rule Designer reports"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Use latest version instead. Generates Rule Designer reports using the v4 schema. Compared to v3.0, it adds derived visit metadata columns outlined in ReportColumnMappingV4 and allows clients to filter on them. This benefits users by improving root-cause analysis for visit-scoped rule behavior. Upgrade to version 5.0 or later to access the audit metadata and expanded schema columns.",
"operationId":"generateReport_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"reportName",
"in":"path",
"description":"Report Name",
"required":true,
"schema":{
"maxLength":128,
"minLength":3,
"type":"string"
},
"example":"RuleExecutionSummary"
}
],
"requestBody":{
"description":"Report Search Specs",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"ReportSearchSpecs":{
"summary":"Filter reports for approved rules",
"description":"ReportSearchSpecs",
"value":{
"limit":25,
"offset":0,
"fieldSpecsList":[
{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved",
"publish"
]
},
{
"fieldName":"ruleEnabled",
"fieldType":"list",
"fieldSequence":2,
"fieldValueList":[
"1"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportSuccess":{
"summary":"Sample paginated report response",
"description":"ReportSuccess",
"value":{
"hasMore":"false",
"totalResults":2,
"count":2,
"limit":25,
"offset":0,
"columns":[
"ruleId",
"ruleName",
"ruleState",
"ruleEnabled",
"studyMode"
],
"data":[
[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved",
"1",
"test"
],
[
"90C7669C40BF4371B71E8EB26851B8AD",
"Overdue Signature Reminder",
"publish",
"1",
"production"
]
]
}
}
}
}
}
},
"400":{
"description":"Invalid search specification. Returned when the request body omits required filters or supplies unsupported field names or data types.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportRequestInvalid":{
"summary":"Invalid filters supplied",
"description":"ReportRequestInvalid",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
},
"500":{
"description":"Unexpected processing failure while compiling the report results. Indicates a downstream data-service error or database issue.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportServerError":{
"summary":"Unexpected error executing report",
"description":"ReportServerError",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v4.0-studies-{studyId}-{mode}-report-{reportName}-post",
"x-filename-id":"ec-rule-designer-svc-rest-v4.0-studies-studyid-mode-report-reportname-post"
}
},
"/ec-rule-designer-svc/rest/v4.0/rule/studies/{studyId}/{mode}/bulkupdate":{
"put":{
"tags":[
"Rule Designer/Rule Management/Update rules in bulk"
],
"summary":"[Deprecated]: v4.0",
"description":"Deprecated: Use latest version instead. Updates multiple rules within a study in a single transaction. Each rule entry must specify operands, actions, and the desired enabled state. Requests are validated against the supplied study mode (design or test) before any persistence changes are committed. Compared to version 3.0, version 4.0 keeps the synchronous contract but aligns with v4 metadata handling. Version 4.0 predates the performance profile and telemetry introduced by versions 6.0 and 7.0. This benefits users by preserving predictable synchronous behavior while adopting v4 payload conventions.",
"operationId":"UpdateRulesBulk_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Request body containing information about all rules for which they need to created or updated",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkUpdateRulesDTOV4"
},
"examples":{
"BulkUpdateRulesDTOV4":{
"summary":"BulkUpdateRulesDTOV4Example",
"description":"BulkUpdateRulesDTOV4",
"value":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleName":"Visit Start Date Validation",
"ruleExpression":"if(var1 != null){ return true; } return false;",
"ruleJSExpression":"if(var1 != null){ return true; } return false;",
"ruleVersionNumber":3,
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginalType":"user rule",
"isLibrary":false,
"ruleEnabled":1,
"ruleDeleted":0,
"studyVersion":"3.2.0.18",
"actions":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"ruleActionTypeName":"auto query",
"ruleActionOrder":1,
"ruleActionDescription":"Open a query when validation fails.",
"ruleActionParams":"Please verify visit start date."
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"(Optional)eventInstanceNumber":1,
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"propertyType":"visit",
"propertyName":"visitStartDate",
"operandName":"var1",
"dataType":"Text",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE"
}
],
"async":0
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk rule update was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk Update Rules Success Response":{
"summary":"Example response for a successful bulk update rules request",
"description":"Bulk Update Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v4.0-rule-studies-{studyId}-{mode}-bulkupdate-put",
"x-filename-id":"ec-rule-designer-svc-rest-v4.0-rule-studies-studyid-mode-bulkupdate-put"
}
},
"/ec-rule-designer-svc/rest/v5.0/studies/{studyId}/{mode}/report/{reportName}":{
"post":{
"tags":[
"Rule Designer/Reporting/Generate Rule Designer reports"
],
"summary":"v5.0",
"description":"Generates Rule Designer reports using the v5 schema. Compared to v4.0, it incorporates audit metadata columns from ReportColumnMappingV5 and enforces the matching filter types. This benefits users by making audit-focused investigations faster and more consistent.",
"operationId":"generateReport_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"reportName",
"in":"path",
"description":"Report Name",
"required":true,
"schema":{
"maxLength":128,
"minLength":3,
"type":"string"
},
"example":"RuleExecutionSummary"
}
],
"requestBody":{
"description":"Report Search Specs",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"ReportSearchSpecs":{
"summary":"Filter reports for approved rules",
"description":"ReportSearchSpecs",
"value":{
"limit":25,
"offset":0,
"fieldSpecsList":[
{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved",
"publish"
]
},
{
"fieldName":"ruleEnabled",
"fieldType":"list",
"fieldSequence":2,
"fieldValueList":[
"1"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportSuccess":{
"summary":"Sample paginated report response",
"description":"ReportSuccess",
"value":{
"hasMore":"false",
"totalResults":2,
"count":2,
"limit":25,
"offset":0,
"columns":[
"ruleId",
"ruleName",
"ruleState",
"ruleEnabled",
"studyMode"
],
"data":[
[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved",
"1",
"test"
],
[
"90C7669C40BF4371B71E8EB26851B8AD",
"Overdue Signature Reminder",
"publish",
"1",
"production"
]
]
}
}
}
}
}
},
"400":{
"description":"Invalid search specification. Returned when the request body omits required filters or supplies unsupported field names or data types.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportRequestInvalid":{
"summary":"Invalid filters supplied",
"description":"ReportRequestInvalid",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
},
"500":{
"description":"Unexpected processing failure while compiling the report results. Indicates a downstream data-service error or database issue.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportServerError":{
"summary":"Unexpected error executing report",
"description":"ReportServerError",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v5.0-studies-{studyId}-{mode}-report-{reportName}-post",
"x-filename-id":"ec-rule-designer-svc-rest-v5.0-studies-studyid-mode-report-reportname-post"
}
},
"/ec-rule-designer-svc/rest/v5.0/rule/studies/{studyId}/{mode}/bulkupdate":{
"put":{
"tags":[
"Rule Designer/Rule Management/Update rules in bulk"
],
"summary":"[Deprecated]: v5.0",
"description":"Deprecated: Use latest version instead. Updates multiple rules within a study in a single transaction. Each rule entry must specify operands, actions, and the desired enabled state. Requests are validated against the supplied study mode (design or test) before any persistence changes are committed. Compared to version 4.0, version 5.0 introduces the execution summary model while retaining synchronous update semantics. Version 5.0 does not include the performance improvements or job tracking metadata delivered starting in version 6.0. This benefits users by exposing richer execution context without requiring asynchronous adoption.",
"operationId":"UpdateRulesBulk_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Request body containing information about all rules for which they need to created or updated",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkUpdateRulesDTOV5"
},
"examples":{
"BulkUpdateRulesDTOV5":{
"summary":"BulkUpdateRulesDTOV5Example",
"description":"BulkUpdateRulesDTOV5",
"value":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleName":"Visit Start Date Validation",
"ruleExpression":"if(var1 != null){ return true; } return false;",
"ruleJSExpression":"if(var1 != null){ return true; } return false;",
"ruleVersionNumber":3,
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginalType":"user rule",
"isLibrary":false,
"ruleEnabled":1,
"ruleDeleted":0,
"studyVersion":"3.2.0.18",
"actions":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"ruleActionTypeName":"auto query",
"ruleActionOrder":1,
"ruleActionDescription":"Open a query when validation fails.",
"ruleActionParams":"Please verify visit start date.",
"propertyType":"visit",
"propertyName":"visitStartDate"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"(Optional)eventInstanceNumber":1,
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"propertyType":"visit",
"propertyName":"visitStartDate",
"operandName":"var1",
"dataType":"Text",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE"
}
],
"async":0
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk rule update was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk Update Rules Success Response":{
"summary":"Example response for a successful bulk update rules request",
"description":"Bulk Update Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"deprecated":true,
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v5.0-rule-studies-{studyId}-{mode}-bulkupdate-put",
"x-filename-id":"ec-rule-designer-svc-rest-v5.0-rule-studies-studyid-mode-bulkupdate-put"
}
},
"/ec-rule-designer-svc/rest/v5.0/rule/studies/{studyId}/{mode}/ruleId/{ruleId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by rule ID"
],
"summary":"v5.0",
"description":"Version 5.0 retrieves rules by identifier and adds validation metadata compared to version 3.0, preparing clients for the execution summary fields introduced in version 6.0. This benefits users by improving rule-detail diagnostics before transitioning to v6.0 execution telemetry.",
"operationId":"getRulesById_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleId",
"in":"path",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"Rule Details for given RuleId":{
"summary":"Example response for a successful rules request",
"description":"Rule Details for given RuleId",
"value":{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v5.0-rule-studies-{studyId}-{mode}-ruleId-{ruleId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v5.0-rule-studies-studyid-mode-ruleid-ruleid-get"
}
},
"/ec-rule-designer-svc/rest/v6.0/studies/{studyId}/{mode}/report/{reportName}":{
"post":{
"tags":[
"Rule Designer/Reporting/Generate Rule Designer reports"
],
"summary":"v6.0",
"description":"Generates Rule Designer reports using the v6 schema. Compared to v5.0, it exposes instrument version tracking fields from ReportColumnMappingV6 and requires filters to align with the expanded schema. This benefits users by improving traceability across instrument-version transitions.",
"operationId":"generateReport_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"36753A48BBA048CB98A5F3278146118D"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"reportName",
"in":"path",
"description":"Report Name",
"required":true,
"schema":{
"maxLength":128,
"minLength":3,
"type":"string"
},
"example":"RuleExecutionSummary"
}
],
"requestBody":{
"description":"Report Search Specs",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"ReportSearchSpecs":{
"summary":"Filter reports for approved rules",
"description":"ReportSearchSpecs",
"value":{
"limit":25,
"offset":0,
"fieldSpecsList":[
{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved",
"publish"
]
},
{
"fieldName":"ruleEnabled",
"fieldType":"list",
"fieldSequence":2,
"fieldValueList":[
"1"
]
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportSuccess":{
"summary":"Sample paginated report response",
"description":"ReportSuccess",
"value":{
"hasMore":"false",
"totalResults":2,
"count":2,
"limit":25,
"offset":0,
"columns":[
"ruleId",
"ruleName",
"ruleState",
"ruleEnabled",
"studyMode"
],
"data":[
[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved",
"1",
"test"
],
[
"90C7669C40BF4371B71E8EB26851B8AD",
"Overdue Signature Reminder",
"publish",
"1",
"production"
]
]
}
}
}
}
}
},
"400":{
"description":"Invalid search specification. Returned when the request body omits required filters or supplies unsupported field names or data types.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportRequestInvalid":{
"summary":"Invalid filters supplied",
"description":"ReportRequestInvalid",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
},
"500":{
"description":"Unexpected processing failure while compiling the report results. Indicates a downstream data-service error or database issue.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"ReportServerError":{
"summary":"Unexpected error executing report",
"description":"ReportServerError",
"value":{
"hasMore":"false",
"totalResults":0,
"count":0,
"limit":25,
"offset":0,
"columns":[
],
"data":[
]
}
}
}
}
}
}
},
"x-internal-id":"ec-rule-designer-svc-rest-v6.0-studies-{studyId}-{mode}-report-{reportName}-post",
"x-filename-id":"ec-rule-designer-svc-rest-v6.0-studies-studyid-mode-report-reportname-post"
}
},
"/ec-rule-designer-svc/rest/v6.0/rule/studies/{studyId}/{mode}/bulkupdate":{
"put":{
"tags":[
"Rule Designer/Rule Management/Update rules in bulk"
],
"summary":"v6.0",
"description":"Version 6.0 updates multiple rules in a single transaction. Compared to version 5.0 it enables the performance-optimized execution path controlled by ENABLE_PERF_IMPROVEMENT while maintaining compatibility with existing payload validation.",
"operationId":"UpdateRulesBulk_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Request body containing information about all rules for which they need to created or updated",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkUpdateRulesDTOV6"
},
"examples":{
"BulkUpdateRulesDTOV6":{
"summary":"BulkUpdateRulesDTOV6Example",
"description":"BulkUpdateRulesDTOV6",
"value":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleName":"Visit Start Date Validation",
"ruleExpression":"if(var1 != null){ return true; } return false;",
"ruleJSExpression":"if(var1 != null){ return true; } return false;",
"ruleVersionNumber":3,
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginalType":"user rule",
"isLibrary":false,
"ruleEnabled":1,
"ruleDeleted":0,
"studyVersion":"3.2.0.18",
"actions":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"ruleActionTypeName":"auto query",
"ruleActionOrder":1,
"ruleActionDescription":"Open a query when validation fails.",
"ruleActionParams":"Please verify visit start date.",
"propertyType":"visit",
"propertyName":"visitStartDate"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"(Optional)eventInstanceNumber":1,
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"propertyType":"visit",
"propertyName":"visitStartDate",
"operandName":"var1",
"dataType":"Text",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"mapRelation":"N"
}
],
"async":0
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk rule update was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk Update Rules Success Response":{
"summary":"Example response for a successful bulk update rules request",
"description":"Bulk Update Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v6.0-rule-studies-{studyId}-{mode}-bulkupdate-put",
"x-filename-id":"ec-rule-designer-svc-rest-v6.0-rule-studies-studyid-mode-bulkupdate-put"
}
},
"/ec-rule-designer-svc/rest/v6.0/rule/studies/{studyId}/{mode}/ruleId/{ruleId}":{
"get":{
"tags":[
"Rule Designer/Rule Management/Get rule by rule ID"
],
"summary":"v6.0",
"description":"Retrieves the rule identified by the supplied rule ID, including the execution summary required by the orchestration service. Compared to v5.0, v6.0 adds job tracking fields and the origin metadata required by the asynchronous publish pipeline. This benefits users by improving publish-tracking visibility during operational support.",
"operationId":"getRulesById_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
},
{
"name":"ruleId",
"in":"path",
"description":"Rule identifier. Required for path parameters targeting a single rule; optional when used as a query filter.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"8E2253D8E53A4A46BAE3E4952CBE9E5A"
}
],
"responses":{
"200":{
"description":"Success.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"Rule Details for given RuleId":{
"summary":"Example response for a successful rules request",
"description":"Rule Details for given RuleId",
"value":{
"status":"success",
"result":{
"message":"Operation completed successfully.",
"processedCount":2
}
}
}
}
}
}
},
"400":{
"description":"Returned when the supplied parameters fail validation or use an unsupported combination of filter values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
},
"500":{
"description":"Returned when no data is available for the supplied study context or identifiers.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"status":"failed",
"result":{
"message":"Rule could not be processed."
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v6.0-rule-studies-{studyId}-{mode}-ruleId-{ruleId}-get",
"x-filename-id":"ec-rule-designer-svc-rest-v6.0-rule-studies-studyid-mode-ruleid-ruleid-get"
}
},
"/ec-rule-designer-svc/rest/v7.0/rule/studies/{studyId}/{mode}/bulkupdate":{
"put":{
"tags":[
"Rule Designer/Rule Management/Update rules in bulk"
],
"summary":"v7.0",
"description":"Updates multiple rules within a study in a single transaction. Compared to v6.0, v7.0 supports rule origin auditing, enforces UUID string validation on each operand, and records asynchronous job identifiers for downstream monitoring. This benefits users by improving auditability and operational traceability for bulk updates.",
"operationId":"UpdateRulesBulk_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Unique study identifier supplied as a UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"required":true,
"schema":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"format":"uuid"
},
"example":"123E4567E89B12D3A456426655440000"
},
{
"name":"mode",
"in":"path",
"description":"Study mode determines the data segment being managed. Allowed values: design (draft configuration workspace), test (UAT sandbox), training (sandbox for practice data), production (live subject data).",
"required":true,
"schema":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Value of the study data segment being managed. Choose one of: design (draft workspace), test (UAT sandbox), training (practice environment), production (live data).",
"example":"test",
"enum":[
"design",
"test",
"training",
"production"
]
},
"example":"test"
}
],
"requestBody":{
"description":"Request body containing information about all rules for which they need to created or updated",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/BulkUpdateRulesDTOV6"
},
"examples":{
"BulkUpdateRulesDTOV6":{
"summary":"BulkUpdateRulesDTOV6Example",
"description":"BulkUpdateRulesDTOV6",
"value":{
"rules":[
{
"ruleId":"38891F5E75BB4071BBF8ACE1F43BD1BD",
"ruleRefName":"VISIT_START_DATE_VALIDATION",
"ruleName":"Visit Start Date Validation",
"ruleExpression":"if(var1 != null){ return true; } return false;",
"ruleJSExpression":"if(var1 != null){ return true; } return false;",
"ruleVersionNumber":3,
"ruleDescription":"Validates visit start date before allowing progression.",
"ruleState":"approved",
"ruleValidationStatus":"true",
"ruleValidationMessage":"Rule validated successfully.",
"ruleOriginalType":"user rule",
"isLibrary":false,
"ruleEnabled":1,
"ruleDeleted":0,
"studyVersion":"3.2.0.18",
"actions":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"ruleActionTypeName":"auto query",
"ruleActionOrder":1,
"ruleActionDescription":"Open a query when validation fails.",
"ruleActionParams":"Please verify visit start date.",
"propertyType":"visit",
"propertyName":"visitStartDate"
}
],
"operands":[
{
"eventId":"9B4AA96F48344015A259D6436EB97B47",
"(Optional)eventInstanceNumber":1,
"formId":"39903D6C042D4D9E89773160488E6D3D",
"itemId":"90C7669C40BF4371B71E8EB26851B8AD",
"propertyType":"visit",
"propertyName":"visitStartDate",
"operandName":"var1",
"dataType":"Text",
"eventRefName":"SCREENING",
"formRefName":"DEMO_FORM",
"itemRefName":"VISIT_START_DATE",
"mapRelation":"N"
}
],
"async":0
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Bulk rule update was successful.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"Bulk Update Rules Success Response":{
"summary":"Example response for a successful bulk update rules request",
"description":"Bulk Update Rules Success Response",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Success",
"ruleValidationMessage":"Rule updated successfully.",
"ruleValidationStatus":true,
"httpErrorCode":200,
"httpErrorMessage":"Success",
"result":{
"status":"success",
"result":{
"message":"Rule updated successfully."
}
},
"error":null
}
}
}
}
}
},
"400":{
"description":"Returned when the request payload is missing required fields, supplies invalid identifiers, or otherwise fails validation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"BadRequest":{
"description":"BadRequest",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
},
"500":{
"description":"Returned when the service encounters an unexpected server-side error while processing the request.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RDSRestUnifiedResponseDTO"
},
"examples":{
"ServerError":{
"description":"ServerError",
"value":{
"ruleId":"8E2253D8E53A4A46BAE3E4952CBE9E5A",
"ruleName":"Visit Start Date Validation",
"jobId":"5F3B2C7890D3413F8C1D019BFB290F34",
"jobStatus":"Failed",
"ruleValidationMessage":"Rule expression cannot be empty.",
"ruleValidationStatus":false,
"httpErrorCode":400,
"httpErrorMessage":"Bad Request",
"result":null,
"error":{
"status":"failed",
"result":null,
"errorCode":"JSON-004",
"errorMessage":"Rule expression is required.",
"details":null
}
}
}
}
}
}
}
},
"security":[
{
"Rule Designer Service":[
]
}
],
"x-internal-id":"ec-rule-designer-svc-rest-v7.0-rule-studies-{studyId}-{mode}-bulkupdate-put",
"x-filename-id":"ec-rule-designer-svc-rest-v7.0-rule-studies-studyid-mode-bulkupdate-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/dispense/kits/{kitId}":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get titration dispensation data"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all data needed to define dispensation of kit type titration. For example, list of assignable visits, treatment arms and randomization designs.",
"operationId":"assignKitTypeTitration_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-dispense-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-design-visits-visitid-dispense-kits-kitid-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/randomizations/{randomizationId}":{
"put":{
"tags":[
"Designer/Visit APIs/Visit Design/Assign randomization to visit"
],
"summary":"V1.0",
"description":"Assigns a randomization to a visit. Use the latest supported visit design endpoint in v17.0 for current behavior.",
"operationId":"assignRandomization_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomizationId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-randomizations-{randomizationId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-design-visits-visitid-randomizations-randomizationid-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get visit design assignments"
],
"summary":"V1.0",
"description":"Retrieves visit design assignments for the study version. Use the latest supported visit design endpoint in v17.0 for current behavior.",
"operationId":"getVisitDesign_15",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV1"
}
},
"examples":{
"getVisitDesignV1Response":{
"description":"getVisitDesignV1Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"randomizationId":"A1B8327AFAA6412287106192AB5984EF"
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/validate/assign/kits/{kitId}":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Assign kit type titration to a visit"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Validates assigning kit type titration to a visit.",
"operationId":"validateAssignKitTypeTitration_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-validate-assign-kits-{kitId}-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-design-visits-visitid-validate-assign-kits-kitid-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/validate/assign/randomization/{randomizationId}":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Validate assigning randomization"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Validates assigning randomization design to a visit.",
"operationId":"validateAssignRandomization_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomizationId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-validate-assign-randomization-{randomizationId}-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-design-visits-visitid-validate-assign-randomization-randomizationid-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/kits/names":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of kit names in a study"
],
"summary":"V1.0",
"description":"Retrieves list of kit names in a study version.",
"operationId":"getStudyKitNames_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTypeIdDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-kits-names-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-kits-names-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get kits from all study versions in Testing, Approved and Archived"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits for all study versions in Testing, Approved and Archived states.",
"operationId":"getStudyNonDraftKitDesc_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDescDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-kits-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/arms":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/List treatment arms"
],
"summary":"V1.0",
"description":"Retrieves treatment arms for the study version. Use the latest supported arm endpoint in v17.0 for current behavior and metadata.",
"operationId":"getArms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmDtoV1"
}
},
"examples":{
"listArmsV1Response":{
"description":"listArmsV1Response",
"value":{
"result":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"Arm A"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-arms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-arms-get"
},
"post":{
"tags":[
"Designer/Treatment Arms APIs/Create treatment arm"
],
"summary":"V1.0",
"description":"Creates a treatment arm for the study version. Use the latest supported arm endpoint in v17.0 for current behavior.",
"operationId":"addArm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Treatment arm payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ArmDtoV1"
},
"examples":{
"createArmV1Request":{
"description":"createArmV1Request",
"value":{
"name":"Arm A",
"refname":"ARM_A"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ArmDtoV1"
},
"examples":{
"createArmV1Response":{
"description":"createArmV1Response",
"value":{
"result":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"Arm A"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-arms-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-arms-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/arms/{armId}":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/Get treatment arm by ID"
],
"summary":"V1.0",
"description":"Retrieves one treatment arm by ID for a study version. Use the latest supported arm endpoint in v17.0 for current behavior.",
"operationId":"getArm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ArmDtoV1"
},
"examples":{
"getArmV1Response":{
"description":"getArmV1Response",
"value":{
"result":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"Arm A"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-arms-{armId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-arms-armid-get"
},
"put":{
"tags":[
"Designer/Treatment Arms APIs/Update treatment arm"
],
"summary":"V1.0",
"description":"Updates a treatment arm for the study version. Use the latest supported arm endpoint in v17.0 for current behavior.",
"operationId":"updateArm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Treatment arm payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ArmDtoV1"
},
"examples":{
"updateArmV1Request":{
"description":"updateArmV1Request",
"value":{
"name":"Arm A Updated",
"refname":"ARM_A"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ArmDtoV1"
},
"examples":{
"updateArmV1Response":{
"description":"updateArmV1Response",
"value":{
"result":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"Arm A Updated"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-arms-{armId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-arms-armid-put"
},
"delete":{
"tags":[
"Designer/Treatment Arms APIs/Delete treatment arm"
],
"summary":"V1.0",
"description":"Deletes a treatment arm from the study version. Use the latest supported arm endpoint in v17.0 for current behavior.",
"operationId":"deleteArm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ArmDtoV1"
},
"examples":{
"deleteArmV1Response":{
"description":"deleteArmV1Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-arms-{armId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-arms-armid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/arms/{armId}/dispensings":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/List arm dispensings"
],
"summary":"V1.0",
"description":"Retrieves arm dispensing assignments. Use the latest supported arm endpoint in v17.0 for current behavior.",
"operationId":"getDispensings_26",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV1"
}
},
"examples":{
"listArmDispensingsV1Response":{
"description":"listArmDispensingsV1Response",
"value":{
"result":[
{
"armId":"B1B8327AFAA6412287106192AB5984EF",
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-arms-{armId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-arms-armid-dispensings-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/codelist/{codeListId}/linkedformsummary":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get linked form summary"
],
"summary":"V1.0",
"description":"Returns linked form summary for a code list within a study.",
"operationId":"getLinkedFormSummary_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"Code List Id",
"in":"path",
"description":"Code List Id Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"codeListId",
"in":"path",
"description":"Code list ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-codelist-{codeListId}-linkedformsummary-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-codelist-codelistid-linkedformsummary-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/cohorts":{
"get":{
"tags":[
"Designer/Study APIs/Study Cohorts/Get a list of all active cohorts in a study"
],
"summary":"V1.0",
"description":"Retrieves a list of all cohorts in a study. You can retrieve this list by study ID.",
"operationId":"getCohorts_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study version mode to filter cohorts.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-cohorts-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-cohorts-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Get list of dispensation visits in a study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves list of all dispensation visits in a study version.",
"operationId":"getDispensings",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-dispensings-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Update list of dispensation visits"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates list of dispensation visits in a study version to create new visits, update existing ones or delete deprecated visits.",
"operationId":"updateDispensings_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randVisitId",
"in":"query",
"description":"Optional visit ID (UUID, 32-character uppercase hexadecimal string) where randomization was assigned. Optional.",
"schema":{
"type":"string",
"default":"empty"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of dispensation mappings to create or update. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV1"
}
},
"examples":{
"updateDispensingsV1Request":{
"description":"updateDispensingsV1Request",
"value":[
{
"armId":"B1B8327AFAA6412287106192AB5984EF",
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-dispensings-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-dispensings-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_25",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV1"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Adds a form in a study version.",
"operationId":"addForm_15",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form to add",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV1"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV1"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/visits":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Bulk assign forms to visits"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Assigns forms to visits in bulk, preserving any previous assignments.",
"operationId":"addFormToVisits_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of form visits",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitsDtoV1"
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"addFormToVisitsV1Response":{
"description":"addFormToVisitsV1Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-visits-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-visits-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/copyForms":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Copy forms in bulk"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Copies all the forms passed in request to the given study and version.",
"operationId":"bulkFormCopy_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Bulk copy of forms",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CopyFormsV1"
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CopyFormsResponse"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-copyForms-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-copyforms-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a specific form in a study version.",
"operationId":"getForm_15",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV1"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates a specific form in a study version.",
"operationId":"updateForm_15",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV1"
},
"examples":{
"updateFormV1Request":{
"description":"updateFormV1Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV1"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a specific form in a study version.",
"operationId":"deleteForm_14",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV1"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/associateForms":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Get associated forms"
],
"summary":"V1.0",
"description":"Returns associated forms impacted by copy mappings. Use the latest supported forms API in v17.0 for current behavior.",
"operationId":"getAssociateForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of all forms which needs to be copied to current study and version.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CopyFormsV1"
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-associateForms-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-associateforms-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/numericItems":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get forms and questions used in dosing calculations"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves forms and questions used in dosing calculations in a study.",
"operationId":"getNumericForms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV1"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-numericItems-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-numericitems-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get list questions used in stratified randomization"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all questions used in stratified randomization designs in a specific study version.",
"operationId":"getStratificationFactors_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV1"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV1"
},
"examples":{
"createKitV1Request":{
"description":"createKitV1Request",
"value":{
"title":"Dose Pack A",
"refname":"KIT_A"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates a kit type in a study.",
"operationId":"updateKit_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV1"
},
"examples":{
"updateKitV1Request":{
"description":"updateKitV1Request",
"value":{
"title":"Dose Pack A Updated",
"refname":"KIT_A"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-kits-kitid-put"
},
"delete":{
"tags":[
"Designer/Kits APIs/Delete a kit"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a kit type from a study.",
"operationId":"deleteKit_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-kits-{kitId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-kits-kitid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/kits/kitsonly":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all investigational product kits and devices"
],
"summary":"V1.0",
"description":"Retrieves list of all investigational product kits and devices in the study.",
"operationId":"getAllKitOnly_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-kits-kitsonly-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-kits-kitsonly-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/kits/{kitId}/dispensings":{
"get":{
"tags":[
"Designer/Kits APIs/Get the dispensation data of a kit"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves dispensation information for a kit in a study.",
"operationId":"getDispensings_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-kits-{kitId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-kits-kitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/{formId}/previewFormNotification":{
"post":{
"tags":[
"Designer/Form APIs/Form Preview/Send a notification to preview a form"
],
"summary":"V1.0",
"description":"Preview Form Notification.",
"operationId":"notify_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Preview form notification request payload. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/WelcomeDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"message":"Welcome to Clinical One Design",
"tenant":"DESIGN"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/WelcomeDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-previewFormNotification-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-previewformnotification-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/randomizationfactors":{
"get":{
"tags":[
"Designer/Study APIs/Study Randomization Factors/Get all active factors in a study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of Study factors. You can retrieve this list by study mode and RandType.",
"operationId":"getRandFactors_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study version mode to filter factors.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"type",
"in":"query",
"description":"Rand Algorithim to filter factors.",
"required":true,
"schema":{
"type":"string",
"default":"ALL",
"enum":[
"stratum",
"cohort",
"minimization",
"all"
]
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationFactorsV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get list of randomization designs in a study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of all randomization designs for a study version.",
"operationId":"getRandomizations_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-get"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization/Create randomization design"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Creates a new randomization design in a study version.",
"operationId":"addRandomization_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV1"
},
"examples":{
"createRandomizationV1Request":{
"description":"createRandomizationV1Request",
"value":{
"name":"RAND_A",
"algorithm":"STRATUM"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get a randomization design"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a randomization design for a study version.",
"operationId":"getRandomization_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization/Update existing randomization design"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates an existing randomization design for a study version.",
"operationId":"updateRandomization_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"requestBody":{
"description":"Randomization payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV1"
},
"examples":{
"updateRandomizationV1Request":{
"description":"updateRandomizationV1Request",
"value":{
"name":"RAND_A_UPDATED",
"algorithm":"STRATUM"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV1"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-put"
},
"delete":{
"tags":[
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],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a randomization design from a study version within a study.",
"operationId":"deleteRandomization_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizationRatios":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get all treatment arm ratios for cohort or stratum groups"
],
"summary":"V1.0",
"description":"Retrieves a list of treatment arm ratios associated with all cohort or stratum groups in a randomization design.",
"operationId":"getRandomizationsList_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
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"items":{
"$ref":"#/components/schemas/RandomizationsGroupingDtoV3"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
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},
"examples":{
"noContentResponse":{
"description":"noContentResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizationRatios-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizationratios-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/tracking/rollback/{trackingId}":{
"post":{
"tags":[
"Designer/Rollback APIs/Rollback tracked transaction"
],
"summary":"V1.0",
"description":"Creates a rollback tracked transaction.",
"operationId":"trackingRollback_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"trackingId",
"in":"path",
"description":"Tracking ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A3B4C5D6E7F84901AB23CD45EF678901"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RollbackDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"status":"completed",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-tracking-rollback-{trackingId}-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-tracking-rollback-trackingid-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/tracking/start":{
"post":{
"tags":[
"Designer/Rollback APIs/Start tracking transaction"
],
"summary":"V1.0",
"description":"Creates a start-tracking transaction.",
"operationId":"trackingStart_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RollbackDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"status":"completed",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-tracking-start-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-tracking-start-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/tracking/stop/{trackingId}":{
"post":{
"tags":[
"Designer/Rollback APIs/Stop tracking transaction"
],
"summary":"V1.0",
"description":"Creates a stop-tracking transaction.",
"operationId":"trackingStop_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"trackingId",
"in":"path",
"description":"Tracking ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"A3B4C5D6E7F84901AB23CD45EF678901"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RollbackDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"status":"completed",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-tracking-stop-{trackingId}-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-tracking-stop-trackingid-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/strata":{
"get":{
"tags":[
"Designer/Randomization APIs/Study Strata/Get all active strata in a study"
],
"summary":"V1.0",
"description":"Retrieves a list of study strata. You can retrieve this list by study mode.",
"operationId":"getStrata_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study version mode to filter strata.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-strata-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-strata-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/studyDesign":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"requestBody":{
"description":"Visit details.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV1"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignMapperV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/lock":{
"get":{
"tags":[
"Designer/Study APIs/Study Lock/Get study lock"
],
"summary":"V1.0",
"description":"Get a lock for a study.",
"operationId":"getStudyLockResponse_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LockDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-lock-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-lock-get"
},
"put":{
"tags":[
"Designer/Study APIs/Study Lock/Update study lock"
],
"summary":"V1.0",
"description":"Update a lock for a study.",
"operationId":"updateLock_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LockDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-lock-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-lock-put"
},
"post":{
"tags":[
"Designer/Study APIs/Study Lock/Create study lock"
],
"summary":"V1.0",
"description":"Create a lock for a study.",
"operationId":"createLock_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LockDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-lock-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-lock-post"
},
"delete":{
"tags":[
"Designer/Study APIs/Study Lock/Delete study lock"
],
"summary":"V1.0",
"description":"Delete a lock for a study.",
"operationId":"deleteLock_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-lock-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-lock-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/studyMetadata":{
"get":{
"tags":[
"Designer/Study APIs/Study Metadata APIs/Get metadata of a specified study ID and study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves metadata for a specified study ID and study version.",
"operationId":"getStudy_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"format",
"in":"query",
"description":"Format for the study metadata",
"required":true,
"schema":{
"type":"string",
"enum":[
"unique",
"casebook"
]
},
"example":"unique"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Study"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-studyMetadata-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-studymetadata-get"
}
},
"/ec-designer-svc/rest/v1.0/studies":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get a list of all studies"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of the latest studies in your system.",
"operationId":"queryStudies_3",
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-get"
},
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Add study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Add a study in your system.",
"operationId":"addStudy_4",
"requestBody":{
"description":"Study payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/forms/{formId}/validate":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Check form in study version"
],
"summary":"V1.0",
"description":"Check a specific form in a study version placed in a Testing or Approved state.",
"operationId":"checkStudyForm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"inclDraft",
"in":"query",
"description":"Include draft entities in validation. Optional. Allowed values: \"Y\" to include drafts, \"N\" (default) to exclude drafts.",
"schema":{
"type":"string",
"default":"N"
},
"example":"N"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"boolean"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":true
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-forms-{formId}-validate-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-forms-formid-validate-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/forms/{formId}/items/{formItemId}/validate":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Check form item existence in study."
],
"summary":"V1.0",
"description":"Check a specific form item existence in any testing or approved study version.",
"operationId":"checkStudyFormItem_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formItemId",
"in":"path",
"description":"Form item ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344"
},
{
"name":"inclDraft",
"in":"query",
"description":"Include draft entities in validation. Optional. Allowed values: \"Y\" to include drafts, \"N\" (default) to exclude drafts.",
"schema":{
"type":"string",
"default":"N"
},
"example":"N"
},
{
"name":"filterOutCondition",
"in":"query",
"description":"Condition used to exclude matching items from validation. Optional.",
"schema":{
"type":"string"
},
"example":"status!=DRAFT"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"boolean"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":true
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-forms-{formId}-items-{formItemId}-validate-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-forms-formid-items-formitemid-validate-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/visits/{visitId}/validate":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Check visit in study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Checks a specific visit in a study version placed in a Testing or Approved state.",
"operationId":"checkStudyVisit_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"boolean"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":true
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-visits-{visitId}-validate-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-visits-visitid-validate-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/cloneSystemCodelist":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Clone system codelist"
],
"summary":"V1.0",
"description":"Clones the system codelist for the study.",
"operationId":"cloneSystemCodeList_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"httpMethod",
"in":"query",
"description":"httpMethod , which is required to identify whether it's create/update action and update the corresponding statuses while cloning the sytem codelist",
"required":true,
"schema":{
"type":"string",
"default":""
},
"example":"POST"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-cloneSystemCodelist-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-clonesystemcodelist-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/allForms":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all forms"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms.",
"operationId":"fetchAllForms_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-allForms-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-allforms-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/forms":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get coding questions in all forms"
],
"summary":"V1.0",
"description":"Retrieves all forms with coding questions in non-draft SVs mode.",
"operationId":"getAllFormsWithCodeQueInNonDraftSV_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-forms-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/allstudiesforms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get all study forms"
],
"summary":"V1.0",
"description":"Retrieves all the forms of the latest study version of other studies.",
"operationId":"getAllStudiesForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"otherStudy",
"in":"query",
"description":"OtherStudy, which can have the value all, or otherStudy ID. It defaults to value first in the absence of query param.",
"required":true,
"schema":{
"type":"string",
"default":"first"
},
"example":1
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/AllStudiesFormsDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-allstudiesforms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-allstudiesforms-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/approved/objectids":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get IDs of all artifacts in an approved study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of IDs of all artifacts in a specified approved study. An artifact refers to anything that belongs to the study design, for example: forms, randomization, treatment arm, kits, etc.",
"operationId":"getApprovedIds_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"all",
"in":"query",
"description":"Include all study artifacts. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"arms",
"in":"query",
"description":"Include treatment arms. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"kits",
"in":"query",
"description":"Include kits. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"rands",
"in":"query",
"description":"Include randomization. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"forms",
"in":"query",
"description":"Include forms. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"items",
"in":"query",
"description":"Include items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"visits",
"in":"query",
"description":"Include visits. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"calculateddoses",
"in":"query",
"description":"Include calculated doses. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"cohorts",
"in":"query",
"description":"Include cohorts and cohort factors. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"inclEverApproved",
"in":"query",
"description":"Include study artifacts that were ever approved. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-approved-objectids-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-approved-objectids-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/arms":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get list of treatment arms for all study versions"
],
"summary":"V1.0",
"description":"Retrieves list of treatment arms for all study versions.",
"operationId":"getArms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"includeAllSubjects",
"in":"query",
"description":"Include dummy entry for all subjects along with all treatment arms. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"mode",
"in":"query",
"description":"Study mode to filter arms.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-arms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-arms-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/{mode}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get a list of study forms"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of forms in a study.",
"operationId":"queryStudyForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"path",
"description":"Study mode to filter study forms.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormSummaryDTOV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-{mode}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-mode-forms-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/approved/choiceoptions":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get options of all choice items in the latest approved version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves options of all choice items in the latest approved version.",
"operationId":"getLatestApprovedChoiceOptions_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-approved-choiceoptions-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-approved-choiceoptions-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/objectids":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get IDs of all artifacts in a study in a specific mode"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of IDs of all artifacts in a study in the specified mode: Testing, Approved and/or Archived. An artifact refers to anything that belongs to the study design, for example: forms, randomization, treatment arm, kits, etc.",
"operationId":"getObjectIds_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studymode",
"in":"query",
"description":"Study modes to search for artifacts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"array",
"items":{
"type":"string",
"enum":[
"design",
"test",
"training",
"active",
"all"
]
}
},
"example":"active"
},
{
"name":"archived",
"in":"query",
"description":"Include the archived versions of a study in a specified mode. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
},
{
"name":"all",
"in":"query",
"description":"Include all study artifacts. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"forms",
"in":"query",
"description":"Include forms. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"items",
"in":"query",
"description":"Include form items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-objectids-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-objectids-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/hasRandomization":{
"post":{
"tags":[
"Designer/Study Version APIs/Get list of combination of study version and boolean representing the existence of randomization"
],
"summary":"V1.0",
"description":"Retrieves the list of study versions take a list of study versions and return true or false in the response for each study version.",
"operationId":"getRandomizationsExistanceByStudyIds_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study versions list Exemple : 1.0.0.1 ,1.0.0.3 Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"1.0.0.1",
"1.0.0.2"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionsRandomizationDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-hasRandomization-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-hasrandomization-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/statuses/{version}":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get status of latest study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves status of a specified study ID and study version.",
"operationId":"getStudy",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"version",
"in":"path",
"description":"Study version. Example: \"1.0.0.1\"",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-statuses-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-statuses-version-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/studycopystatus":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get study rule copy status"
],
"summary":"V1.0",
"description":"Get a list of copy studies that logged in user has access to along with their statuses.",
"operationId":"getStudyRulesCopyStatus_1",
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyCopyStatusDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-studycopystatus-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studycopystatus-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/statuses":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses of a study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatuses_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-statuses-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-statuses-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/statusessummary":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses summary of a study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all statuses summary for a specified study ID.",
"operationId":"getStudyStatusesSummary_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-statusessummary-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-statusessummary-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/forms/formitems":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all form items in a form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all form items in a form by mode.",
"operationId":"queryBulkFormsItems_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Retrieves all form items in a form by mode.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"itemType",
"in":"query",
"description":"Form item types to include in the response. Optional.",
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"example":"instructionalText"
}
],
"requestBody":{
"description":"ItemIds for Choice Options Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-forms-formitems-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-forms-formitems-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/forms/{formId}/choiceoptions":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get options of all choice items by study mode and form ID(s)."
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves options of all choice items by study mode and form ID(s).",
"operationId":"queryChoiceOptions_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Retrieves all form items in a form by mode.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"requestBody":{
"description":"List of form item IDs to include in choice option lookup. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-forms-{formId}-choiceoptions-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-forms-formid-choiceoptions-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/forms/{formId}/formitems":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all form items in a form by form ID"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all form items in a form by ID.",
"operationId":"queryFormItems_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Retrieves all form items in a form by mode.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"itemType",
"in":"query",
"description":"Form item types to include in the response. Optional.",
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"example":"instructionalText"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-forms-{formId}-formitems-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-forms-formid-formitems-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/identity":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get study identity based on protocol ID"
],
"summary":"V1.0",
"description":"Retrieves a study's identity based on protocol ID.",
"operationId":"queryIdentity_1",
"parameters":[
{
"name":"protocolId",
"in":"query",
"description":"Study protocol ID (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"PROTOCOL_001"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyIdentityDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-identity-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-identity-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/maxversion/tenant":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get maximum study versions of a tenant"
],
"summary":"V1.0",
"description":"Get list of latest version of studies by tenant name.",
"operationId":"queryMaxVersionStudiesForTenant_1",
"parameters":[
{
"name":"tenant",
"in":"query",
"description":"Tenant identifier. Optional. If omitted, current request tenant context is used.",
"required":true,
"schema":{
"type":"string"
},
"example":"acme"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-maxversion-tenant-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-maxversion-tenant-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/tenant":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get latest study versions of a tenant"
],
"summary":"V1.0",
"description":"Retrieves a list of all study versions. You can get this list based on a tenant's name.",
"operationId":"queryStudiesForTenant_1",
"parameters":[
{
"name":"tenant",
"in":"query",
"description":"Tenant name Optional.",
"schema":{
"type":"string"
},
"example":"acme"
},
{
"name":"study",
"in":"query",
"description":"Study name Optional.",
"schema":{
"type":"string"
},
"example":"CardioStudy01"
},
{
"name":"studyType",
"in":"query",
"description":"Study type. Allowed values: STANDARD (regular study), LIBRARY (reusable library study). Example: LIBRARY. Optional.",
"schema":{
"type":"string",
"default":"STANDARD"
},
"example":"STANDARD"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-tenant-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-tenant-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/all":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all study versions of multiple tenants"
],
"summary":"V1.0",
"description":"Retrieves a list of all study versions of the specified tenants.",
"operationId":"queryStudiesForTenants_1",
"parameters":[
{
"name":"tenants",
"in":"query",
"description":"List of tenants name Optional.",
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"example":"acme"
},
{
"name":"studyType",
"in":"query",
"description":"Study type. Allowed values: STANDARD (regular study), LIBRARY (reusable library study). Example: LIBRARY. Optional.",
"schema":{
"type":"string",
"default":"STANDARD"
},
"example":"STANDARD"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-all-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-all-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/{mode}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/List visits for a form by study mode"
],
"summary":"V1.0",
"description":"Retrieves visits where the specified form is present for a given study mode (test, training, active).",
"operationId":"queryStudyFormVisits_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"path",
"description":"Study mode to filter study form visits.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitDTOv1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-{mode}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-mode-forms-formid-visits-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/state":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get a study's status"
],
"summary":"V1.0",
"description":"Retrieves the status of a study.",
"operationId":"queryStudyState_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyStateDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-state-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-state-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}":{
"put":{
"tags":[
"Designer/Study APIs/Study Actions/Update existing study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates an existing study.",
"operationId":"updateStudy_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study payload to update. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/studycopystatus":{
"put":{
"tags":[
"Designer/Study APIs/Study Actions/Update study rule copy status"
],
"summary":"V1.0",
"description":"Update study rule copy status for the targetted study.",
"operationId":"updateStudyRulesCopyStatus_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study copy status update payload. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyCopyStatusDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyCopyStatusDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-studycopystatus-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-studycopystatus-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/state/{statedata}":{
"put":{
"tags":[
"Designer/Study APIs/Study Actions/Update a study's state"
],
"summary":"V1.0",
"description":"Updates status of a specified study.",
"operationId":"updateStudyState_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"statedata",
"in":"path",
"description":"Study State. Example: \"ACTIVE\"",
"required":true,
"schema":{
"type":"string"
},
"example":"ACTIVE"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyStateDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-state-{statedata}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-state-statedata-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versionshistory/asofdate/{asofdate}":{
"get":{
"tags":[
"Designer/Study Version APIs/Get history of all versions for a study as of a certain date"
],
"summary":"V1.0",
"description":"Retrieves the history of all versions for a study as of a certain date.",
"operationId":"getStudyVersionsHistory_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"asofdate",
"in":"path",
"description":"As of date parameter in the format yyyy-mm-ddTHH24:MI:SS",
"required":true,
"schema":{
"type":"string"
},
"example":"2024-01-15T10:30:00"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionHistoryDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"400":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versionshistory-asofdate-{asofdate}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versionshistory-asofdate-asofdate-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions":{
"get":{
"tags":[
"Designer/Versions APIs/Get list of study versions"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves list of versions for a specified study.",
"operationId":"getVersions_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VersionDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-get"
},
"post":{
"tags":[
"Designer/Versions APIs/Add study version"
],
"summary":"V1.0",
"description":"Adds versions for a specific study.",
"operationId":"addVersion_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"requestBody":{
"description":"Study payload used to add a new draft version. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}":{
"get":{
"tags":[
"Designer/Versions APIs/Get version of a study"
],
"summary":"V1.0",
"description":"Retrieves a single version for a specified study.",
"operationId":"getSingleVersion_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version id",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VersionDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-get"
},
"put":{
"tags":[
"Designer/Versions APIs/Update study version"
],
"summary":"V1.0",
"description":"Updates a specified study's version.",
"operationId":"updateVersion_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version id",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"The study payload used to update version/title",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/JsonNode"
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV3"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-put"
},
"delete":{
"tags":[
"Designer/Versions APIs/Delete study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a study's version.",
"operationId":"deleteStudy_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version id",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/status/{state}/async":{
"put":{
"tags":[
"Designer/Versions APIs/Update status of study version asynchronously"
],
"summary":"V1.0",
"description":"Updates status of a specific study version asynchronously.",
"operationId":"movingStudyVersionOrchestrator_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version ID",
"required":true,
"schema":{
"pattern":"^([0-9]+(\\.[0-9]+){3})$",
"type":"string"
},
"example":"1.0.0.1"
},
{
"name":"state",
"in":"path",
"description":"Target study version state. Required.",
"required":true,
"schema":{
"pattern":"^[a-zA-Z][a-zA-Z_]+[a-zA-Z]$",
"type":"string"
},
"example":"testing"
}
],
"requestBody":{
"description":"The study version",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VersionDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-status-{state}-async-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-status-state-async-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/revert":{
"put":{
"tags":[
"Designer/Versions APIs/Remove duplicate study version"
],
"summary":"V1.0",
"description":"Removes duplicate data for a specific study version.",
"operationId":"removeDuplicateVersionData_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version id",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-revert-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-revert-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/status/{state}":{
"put":{
"tags":[
"Designer/Versions APIs/Update status of study version"
],
"summary":"V1.0",
"description":"Updates status of a specific study version.",
"operationId":"updateStudyVersionStatus_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version id",
"required":true,
"schema":{
"pattern":"^([0-9]+(\\.[0-9]+){3})$",
"type":"string"
},
"example":"1.0.0.1"
},
{
"name":"state",
"in":"path",
"description":"Target study version state. Required.",
"required":true,
"schema":{
"pattern":"^[a-zA-Z][a-zA-Z_]+[a-zA-Z]$",
"type":"string"
},
"example":"testing"
}
],
"requestBody":{
"description":"Study version payload used during status update. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyVersionDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-status-{state}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-status-state-put"
},
"post":{
"tags":[
"Designer/Versions APIs/Set status of study version"
],
"summary":"V1.0",
"description":"Sets a status for a specific study version.",
"operationId":"setStudyVersionStatus_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version id",
"required":true,
"schema":{
"pattern":"^([0-9]+(\\.[0-9]+){3})$",
"type":"string"
},
"example":"1.0.0.1"
},
{
"name":"state",
"in":"path",
"description":"Target study version state. Required.",
"required":true,
"schema":{
"pattern":"^[a-zA-Z][a-zA-Z_]+[a-zA-Z]$",
"type":"string"
},
"example":"testing"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-status-{state}-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-status-state-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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],
"requestBody":{
"description":"Visit payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV1"
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"examples":{
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"description":"requestExample",
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"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
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"order":1
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}
}
}
},
"required":true
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"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV1"
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"description":"successResponse",
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{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
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]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-post"
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule in a study.",
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{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
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"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
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"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
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],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
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}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-schedule-get"
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"put":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Update visit schedule"
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use this other API instead: /{visitid}/schedule/{fromEventRefId} - Updates visit schedule in your study.",
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"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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{
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"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
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"requestBody":{
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"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
},
"examples":{
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"description":"requestExample",
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"name":"Baseline",
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}
}
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"description":"Successful operation.",
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"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
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"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
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}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
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}
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}
},
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use this other API instead: /{visitid}/schedule/{fromEventRefId} - Creates a visit schedule for your study.",
"operationId":"createVisitSchedule_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"type":"string",
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"minLength":1,
"type":"string",
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"example":"1.0.0.1"
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{
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"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
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"description":"Visit schedule payload to create. Required.",
"content":{
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"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
},
"examples":{
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"description":"requestExample",
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"name":"Baseline",
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}
}
}
}
},
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"responses":{
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"description":"Successful operation.",
"content":{
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"schema":{
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"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
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}
}
}
}
}
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"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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}
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},
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"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-schedule-post"
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"tags":[
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. /{visitid}/schedule/{fromEventRefId} - Removes visit schedule from your study.",
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"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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{
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"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
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"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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{
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"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
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],
"responses":{
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"description":"Successful operation.",
"content":{
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"schema":{
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"examples":{
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"description":"successResponse",
"value":{
"result":{
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"name":"Baseline",
"day":1
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}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-schedule-delete"
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},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
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"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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{
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"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
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],
"responses":{
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"description":"Successful operation.",
"content":{
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"schema":{
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"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
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],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
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"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload to update. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV1"
},
"examples":{
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"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
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"delete":{
"tags":[
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings/hasTitration":{
"get":{
"tags":[
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],
"summary":"V1.0",
"description":"Identifies if a visit contains a kit type titration.",
"operationId":"getHasDispensing_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"boolean"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":true
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-hasTitration-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-dispensings-hastitration-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/visitschedules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule of a study.",
"operationId":"getVisitSchedule",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visitschedules-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visitschedules-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/branches":{
"get":{
"tags":[
"Designer/Branch APIs/Get a list of study branches"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of branches in a study.",
"operationId":"getBranches_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-branches-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-branches-get"
},
"post":{
"tags":[
"Designer/Branch APIs/Add a branch"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Adds a branch in your study.",
"operationId":"addBranch_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Visit branch payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitBranchDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-branches-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-branches-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/branches/{branchid}":{
"get":{
"tags":[
"Designer/Branch APIs/Get study branch"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a branch in a study.",
"operationId":"getBranch_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"branchid",
"in":"path",
"description":"Visit branch ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitBranchDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-branches-{branchid}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-branches-branchid-get"
},
"put":{
"tags":[
"Designer/Branch APIs/Update a branch"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates a branch in your study.",
"operationId":"updateBranch_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"branchid",
"in":"path",
"description":"Visit branch ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Visit branch payload to update. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitBranchDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-branches-{branchid}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-branches-branchid-put"
},
"delete":{
"tags":[
"Designer/Branch APIs/Delete a branch"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a branch from your study.",
"operationId":"deleteBranch_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"branchid",
"in":"path",
"description":"Visit branch ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-branches-{branchid}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-branches-branchid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/visitsforms":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get all visits, forms, and questions by study ID"
],
"summary":"V1.0",
"description":"Get all visits, forms, questions by a study ID and one or more study versions.",
"operationId":"queryVisitsForms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"versions",
"in":"query",
"description":"comma separated list of study version numbers.",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1,1.0.0.2"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsFormsQuestionsDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-visitsforms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-visitsforms-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/visitsMetadata":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Metadata/Get the metadata of specified visits by study ID and study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves metadata for specified visits in different study versions.",
"operationId":"queryVisitsForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"requestBody":{
"description":"Study version visit details. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV1"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ODM1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-visitsMetadata-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-visitsmetadata-post"
}
},
"/ec-designer-svc/rest/v1.0/report/{reportName}":{
"post":{
"tags":[
"Designer/Reporting APIs/Generate study design reports"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves study-design data in paginated format based on the selected report name and filters. Access requires the StudyDesignReportPost permission.",
"operationId":"generateDesignerReport_3",
"parameters":[
{
"name":"reportName",
"in":"path",
"description":"The report section name",
"required":true,
"schema":{
"type":"string",
"enum":[
"DESIGNER_VISITS_SECTION",
"STUDY_DESIGN_SUMMARY",
"DESIGNER_KITS_SECTION",
"DESIGNER_FORMS_SECTION",
"DESIGNER_KIT_DISPENSATION_SECTION",
"DESIGNER_RANDOMIZATION_SECTION",
"DESIGNER_STRATIFICATION_SECTION",
"DESIGNER_RANDOMIZATION_TREATMENT_ARMS",
"CALCULATED_DOSES",
"DESIGNER_COHORT_TREATMENT_ARMS",
"DESIGNER_DEMOGRAPHY_COHORTS",
"KIT_TYPE_TITRATIONS",
"DESIGNER_TITRATION_KIT_SETTINGS",
"DESIGNER_TITRATION_KIT_SETTINGS",
"DESIGNER_RULES_SECTION",
"DESIGNER_GENERAL_STUDY_SETTINGS",
"DESIGNER_FORMS_BY_VISITS_SECTION"
]
},
"example":"DESIGNER_VISITS_SECTION"
},
{
"name":"studyId",
"in":"query",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"isLocalized",
"in":"query",
"description":"Indicates whether to localize the report data Optional.",
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"fileType",
"in":"query",
"description":"Output format. Allowed values: plain (plain text output), html (rich text output). Optional.",
"schema":{
"type":"string",
"default":"plain"
},
"example":"plain"
},
{
"name":"mode",
"in":"query",
"description":"Mode of report Optional.",
"schema":{
"type":"string",
"default":"design"
},
"example":"design"
}
],
"requestBody":{
"description":"The search filter Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"offset":0,
"limit":100
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"400":{
"description":"'studyId is a mandatory filter criteria', 'studyVersion is a mandatory filter criteria', 'Filter Criteria can not be empty', 'Invalid Offset', 'Invalid Limit', 'Missing Request Body'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-report-{reportName}-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-report-reportname-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/studyObjectsMapping":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get study object mappings"
],
"summary":"V1.0",
"description":"Returns study object mappings from source study to target study.",
"operationId":"post_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"requestBody":{
"description":"Return to/from forms and visits",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RqstFromToStudyDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"fromStudyId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"toStudyId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
}
}
}
},
"required":true
},
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-studyObjectsMapping-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-studyobjectsmapping-post"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"V10.0",
"description":"Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"If true, generate light version of the API. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV10"
}
},
"examples":{
"getVisitDesignV10Response":{
"description":"getVisitDesignV10Response",
"value":{
"result":{
"visitBranches":[
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV10"
}
},
"examples":{
"getVisitDesignV10NoContent":{
"description":"getVisitDesignV10NoContent",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Get visits associated with a form"
],
"summary":"V10.0",
"description":"Retrieves visits associated with a specific form in a study.",
"operationId":"getVisits_5",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"response",
"in":"query",
"description":"Response type to query visit forms Optional.",
"schema":{
"type":"string",
"default":"",
"enum":[
"",
"summary",
"summaryLite"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV9"
}
},
"examples":{
"getVisitsV10Response":{
"description":"getVisitsV10Response",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Visit 1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-formid-visits-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Process visits to associate with a specific form"
],
"summary":"V10.0",
"description":"Processes visits to be associated with a specific form in a study.",
"operationId":"processFormVisits_5",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of visits to associate with a form. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov10"
}
},
"examples":{
"processFormVisitsV10Request":{
"description":"processFormVisitsV10Request",
"value":[
{
"name":"visitIds",
"value":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"processFormVisitsV10Response":{
"description":"processFormVisitsV10Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-formid-visits-post"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_26",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV11"
}
},
"examples":{
"listFormsV10Response":{
"description":"listFormsV10Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV11"
},
"examples":{
"createFormV10Request":{
"description":"createFormV10Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV11"
},
"examples":{
"createFormV10Response":{
"description":"createFormV10Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study version mode.",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV11"
},
"examples":{
"getFormV10Response":{
"description":"getFormV10Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV11"
},
"examples":{
"updateFormV10Request":{
"description":"updateFormV10Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV11"
},
"examples":{
"updateFormV10Response":{
"description":"updateFormV10Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV11"
},
"examples":{
"deleteFormV10Response":{
"description":"deleteFormV10Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get list questions used in stratified randomization"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead. Retrieves all questions used in stratified randomization designs in a specific study version.",
"operationId":"getStratificationFactors",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov11"
}
},
"examples":{
"getStratificationFactorsV10Response":{
"description":"getStratificationFactorsV10Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Treatment Arm"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/studyDesign":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"V10.0",
"description":"Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"Visit details.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV9"
}
},
"examples":{
"getStudyDesignV10Request":{
"description":"getStudyDesignV10Request",
"value":[
{
"version":"1.0.0.1",
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV11"
}
},
"examples":{
"getStudyDesignV10Response":{
"description":"getStudyDesignV10Response",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Visit 1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/design":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Create study design visits for multiple versions"
],
"summary":"V10.0",
"description":"Creates list of visits for multiple versions in a study's design.",
"operationId":"getVisitDesign",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"If true, generate light version of the API. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"List of Study Versions.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"createVisitDesignV10Request":{
"description":"createVisitDesignV10Request",
"value":[
"1.0.0.1",
"1.0.0.2"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV10"
}
},
"examples":{
"createVisitDesignV10Response":{
"description":"createVisitDesignV10Response",
"value":{
"result":{
"1.0.0.1":{
"visitBranches":[
]
}
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV10"
}
},
"examples":{
"createVisitDesignV10NoContent":{
"description":"createVisitDesignV10NoContent",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-design-post",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-design-post"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V10.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study version mode to filter forms.",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV11"
}
},
"examples":{
"listVisitFormsV10Response":{
"description":"listVisitFormsV10Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/visits":{
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"V10.0",
"description":"Adds a visit in your study.",
"operationId":"addVisit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"toTop",
"in":"query",
"description":"Add visit to top in branch schedule Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"copyScreeningVisit",
"in":"query",
"description":"Copy the screening event to make an identical re-screen event Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"requestBody":{
"description":"Visit payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV10"
},
"examples":{
"addVisitV10Request":{
"description":"addVisitV10Request",
"value":{
"name":"Visit 1",
"type":"regular"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV10"
}
},
"examples":{
"addVisitV10Response":{
"description":"addVisitV10Response",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Visit 1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v10.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"V10.0",
"description":"Retrieves a visit in a study.",
"operationId":"getVisit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV10"
},
"examples":{
"getVisitV10Response":{
"description":"getVisitV10Response",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Visit 1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"V10.0",
"description":"Updates a visit in your study.",
"operationId":"updateVisit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload to update. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV10"
},
"examples":{
"updateVisitV10Request":{
"description":"updateVisitV10Request",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Visit 1 Updated",
"type":"regular"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV10"
}
},
"examples":{
"updateVisitV10Response":{
"description":"updateVisitV10Response",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Visit 1 Updated"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"V10.0",
"description":"Removes a visit from your study.",
"operationId":"deleteVisit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV10"
}
},
"examples":{
"deleteVisitV10Response":{
"description":"deleteVisitV10Response",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"deleted":true
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v10.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v10.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v11.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"taggedOnly",
"in":"query",
"description":"Return only forms that contain tagged items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV12"
}
},
"examples":{
"listFormsV11Response":{
"description":"listFormsV11Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV12"
},
"examples":{
"createFormV11Request":{
"description":"createFormV11Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV12"
},
"examples":{
"createFormV11Response":{
"description":"createFormV11Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v11.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV12"
},
"examples":{
"getFormV11Response":{
"description":"getFormV11Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV12"
},
"examples":{
"updateFormV11Request":{
"description":"updateFormV11Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV12"
},
"examples":{
"updateFormV11Response":{
"description":"updateFormV11Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV12"
},
"examples":{
"deleteFormV11Response":{
"description":"deleteFormV11Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v11.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get list questions used in stratified randomization"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Retrieves all questions used in stratified randomization designs in a specific study version.",
"operationId":"getStratificationFactors_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"excludeRepeatFormItems",
"in":"query",
"description":"Exclude Repeat Form Items Optional.",
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"includeAllNumberItems",
"in":"query",
"description":"Include all number items in stratification factor response. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov11"
}
},
"examples":{
"listStratificationFactorsV11Response":{
"description":"listStratificationFactorsV11Response",
"value":{
"result":[
{
"id":"4A5C8D0E2F1B4D56A23C9F3A0C7D4E99",
"name":"Age Group",
"itemType":"NUMBER"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v11.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get unblinded form"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Retrieves one unblinded form. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}` for the active unblinded endpoint.",
"operationId":"getUnblindedForm_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV12"
},
"examples":{
"getUnblindedFormV11Response":{
"description":"getUnblindedFormV11Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-unblinded-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-unblinded-formid-get"
}
},
"/ec-designer-svc/rest/v11.0/studies/{studyId}/versions/{version}/forms/unblinded":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List unblinded forms"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Retrieves unblinded forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded` for the active endpoint.",
"operationId":"getUnblindedForms_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV12"
}
},
"examples":{
"listUnblindedFormsV11Response":{
"description":"listUnblindedFormsV11Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-forms-unblinded-get",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-forms-unblinded-get"
}
},
"/ec-designer-svc/rest/v11.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V11.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter cohorts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV12"
}
},
"examples":{
"listVisitFormsV11Response":{
"description":"listVisitFormsV11Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v11.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v11.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v12.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"taggedOnly",
"in":"query",
"description":"Return only forms that contain tagged items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov13"
}
},
"examples":{
"listFormsV12Response":{
"description":"listFormsV12Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov13"
},
"examples":{
"createFormV12Request":{
"description":"createFormV12Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov13"
},
"examples":{
"createFormV12Response":{
"description":"createFormV12Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v12.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov13"
},
"examples":{
"getFormV12Response":{
"description":"getFormV12Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov13"
},
"examples":{
"updateFormV12Request":{
"description":"updateFormV12Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov13"
},
"examples":{
"updateFormV12Response":{
"description":"updateFormV12Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov13"
},
"examples":{
"deleteFormV12Response":{
"description":"deleteFormV12Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v12.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get list questions used in stratified randomization"
],
"summary":"V12.0",
"description":"Retrieves all questions used in stratified randomization designs in a specific study version.",
"operationId":"getStratificationFactors_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"excludeRepeatFormItems",
"in":"query",
"description":"Exclude Repeat Form Items Optional.",
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"includeAllNumberItems",
"in":"query",
"description":"Include all number items in stratification factor response. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov19"
}
},
"examples":{
"listStratificationFactorsV12Response":{
"description":"listStratificationFactorsV12Response",
"value":{
"result":[
{
"id":"4A5C8D0E2F1B4D56A23C9F3A0C7D4E99",
"name":"Age Group",
"itemType":"NUMBER"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v12.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get unblinded form"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Retrieves one unblinded form. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}` for the active unblinded endpoint.",
"operationId":"getUnblindedForm",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov13"
},
"examples":{
"getUnblindedFormV12Response":{
"description":"getUnblindedFormV12Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-unblinded-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-unblinded-formid-get"
}
},
"/ec-designer-svc/rest/v12.0/studies/{studyId}/versions/{version}/forms/unblinded":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List unblinded forms"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Retrieves unblinded forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded` for the active endpoint.",
"operationId":"getUnblindedForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
},
{
"name":"includeExtProps",
"in":"query",
"description":"Request the lite version of the response to include form items extended properties. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov13"
}
},
"examples":{
"listUnblindedFormsV12Response":{
"description":"listUnblindedFormsV12Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-forms-unblinded-get",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-forms-unblinded-get"
}
},
"/ec-designer-svc/rest/v12.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V12.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter cohorts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov13"
}
},
"examples":{
"listVisitFormsV12Response":{
"description":"listVisitFormsV12Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v12.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v12.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v13.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V13.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter cohorts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"asofdate",
"in":"query",
"description":"As-of date for historical form view in YYYY-MM-DD format. Optional.",
"schema":{
"type":"string"
},
"example":"2025-01-15"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov13"
}
},
"examples":{
"listVisitFormsV13Response":{
"description":"listVisitFormsV13Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v13.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v13.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v14.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"taggedOnly",
"in":"query",
"description":"Return only forms that contain tagged items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov14"
}
},
"examples":{
"listFormsV14Response":{
"description":"listFormsV14Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov14"
},
"examples":{
"createFormV14Request":{
"description":"createFormV14Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov14"
},
"examples":{
"createFormV14Response":{
"description":"createFormV14Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v14.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov14"
},
"examples":{
"getFormV14Response":{
"description":"getFormV14Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov14"
},
"examples":{
"updateFormV14Request":{
"description":"updateFormV14Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov14"
},
"examples":{
"updateFormV14Response":{
"description":"updateFormV14Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov14"
},
"examples":{
"deleteFormV14Response":{
"description":"deleteFormV14Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v14.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get unblinded form"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Retrieves one unblinded form. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}` for the active unblinded endpoint.",
"operationId":"getUnblindedForm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov14"
},
"examples":{
"getUnblindedFormV14Response":{
"description":"getUnblindedFormV14Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-forms-unblinded-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-forms-unblinded-formid-get"
}
},
"/ec-designer-svc/rest/v14.0/studies/{studyId}/versions/{version}/forms/unblinded":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List unblinded forms"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Retrieves unblinded forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded` for the active endpoint.",
"operationId":"getUnblindedForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
},
{
"name":"includeExtProps",
"in":"query",
"description":"Request the lite version of the response to include form items extended properties. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov14"
}
},
"examples":{
"listUnblindedFormsV14Response":{
"description":"listUnblindedFormsV14Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-forms-unblinded-get",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-forms-unblinded-get"
}
},
"/ec-designer-svc/rest/v14.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V14.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter cohorts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"asofdate",
"in":"query",
"description":"As-of date for historical form view in YYYY-MM-DD format. Optional.",
"schema":{
"type":"string"
},
"example":"2025-01-15"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov14"
}
},
"examples":{
"listVisitFormsV14Response":{
"description":"listVisitFormsV14Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v14.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v14.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v15.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` instead.",
"operationId":"getForms_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"taggedOnly",
"in":"query",
"description":"Return only forms that contain tagged items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov15"
}
},
"examples":{
"listFormsV15Response":{
"description":"listFormsV15Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and v17 metadata mapping.",
"operationId":"addForm_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov15"
},
"examples":{
"createFormV15Request":{
"description":"createFormV15Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov15"
},
"examples":{
"createFormV15Response":{
"description":"createFormV15Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v15.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Retrieves a specific form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` instead.",
"operationId":"getForm_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov15"
},
"examples":{
"getFormV15Response":{
"description":"getFormV15Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov15"
},
"examples":{
"updateFormV15Request":{
"description":"updateFormV15Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov15"
},
"examples":{
"updateFormV15Response":{
"description":"updateFormV15Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov15"
},
"examples":{
"deleteFormV15Response":{
"description":"deleteFormV15Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v15.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get unblinded form"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Retrieves one unblinded form. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}` for the active unblinded form endpoint.",
"operationId":"getUnblindedForm_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov15"
},
"examples":{
"getUnblindedFormV15Response":{
"description":"getUnblindedFormV15Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-forms-unblinded-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-forms-unblinded-formid-get"
}
},
"/ec-designer-svc/rest/v15.0/studies/{studyId}/versions/{version}/forms/unblinded":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List unblinded forms"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Retrieves unblinded forms for a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/unblinded` for the active endpoint.",
"operationId":"getUnblindedForms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
},
{
"name":"includeExtProps",
"in":"query",
"description":"Request the lite version of the response to include form items extended properties. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov15"
}
},
"examples":{
"listUnblindedFormsV15Response":{
"description":"listUnblindedFormsV15Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-forms-unblinded-get",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-forms-unblinded-get"
}
},
"/ec-designer-svc/rest/v15.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V15.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter cohorts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"asofdate",
"in":"query",
"description":"As-of date for historical form view in YYYY-MM-DD format. Optional.",
"schema":{
"type":"string"
},
"example":"2025-01-15"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov15"
}
},
"examples":{
"getVisitFormsV15Response":{
"description":"getVisitFormsV15Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v15.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v15.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v16.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V16.0",
"description":"Deprecated: Use latest version instead. Returns a specific form in v16.0 for the requested study version. Compared with v15.0, v16.0 introduces updated handling for visit-form retrieval dependencies and form metadata behavior.",
"operationId":"getForm_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov16"
},
"examples":{
"getFormV16Response":{
"description":"getFormV16Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v16.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v16.0-studies-studyid-versions-version-forms-formid-get"
}
},
"/ec-designer-svc/rest/v16.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V16.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter cohorts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"asofdate",
"in":"query",
"description":"As-of date for historical form view in YYYY-MM-DD format. Optional.",
"schema":{
"type":"string"
},
"example":"2025-01-15"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov16"
}
},
"examples":{
"getVisitFormsV16Response":{
"description":"getVisitFormsV16Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v16.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v16.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v17.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"V17.0",
"description":"Returns forms for the requested study version in v17.0. Compared with v16.0, v17.0 supports richer response controls such as tagged-only filtering and dynamic-data handling in this endpoint.",
"operationId":"getForms_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"taggedOnly",
"in":"query",
"description":"Return only forms that contain tagged items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov17"
}
},
"examples":{
"listFormsV17Response":{
"description":"listFormsV17Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM",
"versionStart":"2025-04-30T09:24:15Z"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"V17.0",
"description":"Creates a new form in v17.0 for the requested study version. Compared with v16.0, v17.0 aligns create behavior with v17 response mapping and extended form metadata handling.",
"operationId":"addForm_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov17"
},
"examples":{
"createFormV17Request":{
"description":"createFormV17Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov17"
},
"examples":{
"createFormV17Response":{
"description":"createFormV17Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v17.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"V17.0",
"description":"Returns a specific form in v17.0 for the requested study version. Compared with v16.0, v17.0 improves compatibility with enhanced hidden-item behavior and dynamic-data processing.",
"operationId":"getForm_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov17"
},
"examples":{
"getFormV17Response":{
"description":"getFormV17Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"V17.0",
"description":"Updates a specific form in v17.0 for the requested study version. Compared with v16.0, v17.0 aligns update behavior with v17 form metadata and mapping expectations.",
"operationId":"updateForm_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov17"
},
"examples":{
"updateFormV17Request":{
"description":"updateFormV17Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov17"
},
"examples":{
"updateFormV17Response":{
"description":"updateFormV17Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"V17.0",
"description":"Deletes a specific form in v17.0 from the requested study version. Compared with v16.0, v17.0 deletion is aligned with updated form-lock and response behavior.",
"operationId":"deleteForm_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov17"
},
"examples":{
"deleteFormV17Response":{
"description":"deleteFormV17Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v17.0/studies/{studyId}/versions/{version}/forms/unblinded/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get unblinded form"
],
"summary":"V17.0",
"description":"Returns one unblinded form in v17.0 for users with unblinded access. Compared with v16.0, v17.0 keeps unblinded retrieval consistent with updated dynamic-data behavior.",
"operationId":"getUnblindedForm_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtov17"
},
"examples":{
"getUnblindedFormV17Response":{
"description":"getUnblindedFormV17Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-forms-unblinded-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-forms-unblinded-formid-get"
}
},
"/ec-designer-svc/rest/v17.0/studies/{studyId}/versions/{version}/forms/unblinded":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List unblinded forms"
],
"summary":"V17.0",
"description":"Returns all unblinded forms in v17.0 for users with unblinded access. Compared with v16.0, v17.0 supports a more complete unblinded response configuration including lite and extended properties flags.",
"operationId":"getUnblindedForms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
},
{
"name":"includeExtProps",
"in":"query",
"description":"Request the lite version of the response to include form items extended properties. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov17"
}
},
"examples":{
"listUnblindedFormsV17Response":{
"description":"listUnblindedFormsV17Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Dose Administration"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-forms-unblinded-get",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-forms-unblinded-get"
}
},
"/ec-designer-svc/rest/v17.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"V17.0",
"description":"Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_13",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response type for visit forms. Optional. Allowed values: summary, summaryLite, details.",
"schema":{
"type":"string",
"default":"summary",
"enum":[
"",
"summary",
"summaryLite",
"details"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter cohorts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
},
{
"name":"asofdate",
"in":"query",
"description":"As-of date for historical form view in YYYY-MM-DD format. Optional.",
"schema":{
"type":"string"
},
"example":"2025-01-15"
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov17"
}
},
"examples":{
"getVisitFormsV17Response":{
"description":"getVisitFormsV17Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v17.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v17.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/dispense/kits/{kitId}":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get titration dispensation data"
],
"summary":"V2.0",
"description":"Retrieves all data needed to define dispensation of kit type titration. For example, list of assignable visits, treatment arms and randomization designs.",
"operationId":"assignKitTypeTitration",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
},
{
"name":"branchIds",
"in":"query",
"description":"Branch IDs in the visits schedule",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-dispense-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-design-visits-visitid-dispense-kits-kitid-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/validate/assign/kits/{kitId}":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Assign kit type titration to a visit"
],
"summary":"V2.0",
"description":"Validates assigning kit type titration to a visit.",
"operationId":"validateAssignKitTypeTitration",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-validate-assign-kits-{kitId}-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-design-visits-visitid-validate-assign-kits-kitid-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/validate/assign/randomization/{randomizationId}":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Validate assigning randomization"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Validates assigning randomization design to a visit.",
"operationId":"validateAssignRandomization",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomizationId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"branchIds",
"in":"query",
"description":"Branch IDs in the visits schedule",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-validate-assign-randomization-{randomizationId}-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-design-visits-visitid-validate-assign-randomization-randomizationid-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get kits from all study versions in Testing, Approved and Archived"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits for all study versions in Testing, Approved and Archived states.",
"operationId":"getStudyNonDraftKitDesc",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode to filter kits.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDescDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-kits-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/arms/{armId}/dispensings":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/Get list of treatment arm dispensations in a study version"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of treatment arm dispensations for a study version.",
"operationId":"getDispensings_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Treatment arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-arms-{armId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-arms-armid-dispensings-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Get list of dispensation visits in a study version"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves list of all dispensation visits in a study version.",
"operationId":"getDispensings_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-dispensings-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Update list of dispensation visits"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Updates list of dispensation visits in a study version to create new visits, update existing ones or delete deprecated visits.",
"operationId":"updateDispensings",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randVisitId",
"in":"query",
"description":"Visit ID where randomization was assigned (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"default":"empty"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of ArmKitVisit DTOs used to update existing study version dispensings.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV2"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-dispensings-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-dispensings-put"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"V2.0",
"description":"Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_14",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV2"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Adds a form in a study version.",
"operationId":"addForm_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form to add",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV2"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV2"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms/visits":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Bulk assign forms to visits"
],
"summary":"V2.0",
"description":"Assigns forms to visits in bulk, preserving any previous assignments.",
"operationId":"addFormToVisits",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of form visits",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitsDtoV1"
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"addFormToVisitsV2Response":{
"description":"addFormToVisitsV2Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-visits-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-visits-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms/copyForms":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Copy forms in bulk"
],
"summary":"V2.0",
"description":"Copies all the forms passed in request to the given study and version.",
"operationId":"bulkFormCopy",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"include",
"in":"query",
"description":"Optional include filter for copy behavior. Optional.",
"schema":{
"type":"string"
},
"example":"dependencies"
}
],
"requestBody":{
"description":"List of source and target form mappings to copy. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CopyForms"
}
},
"examples":{
"copyFormsV2Request":{
"description":"copyFormsV2Request",
"value":[
{
"sourceVersion":"1",
"sourceFormRefname":"DM",
"targetVersion":"2"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CopyFormsResponse"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-copyForms-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-copyforms-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"V2.0",
"description":"Retrieves a specific form in a study version.",
"operationId":"getForm_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV2"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"V2.0",
"description":"Updates a specific form in a study version.",
"operationId":"updateForm_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV2"
},
"examples":{
"updateFormV2Request":{
"description":"updateFormV2Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV2"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"V2.0",
"description":"Removes a specific form in a study version.",
"operationId":"deleteForm_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV2"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms/numericItems":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get forms and questions used in dosing calculations"
],
"summary":"V2.0",
"description":"Retrieves forms and questions used in dosing calculations in a study.",
"operationId":"getNumericForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formCategory",
"in":"query",
"description":"Form category filter. Optional. Default is `DCS`. Accepted values are maintained by `FormCategoryEnum`.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtov17"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-numericItems-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-numericitems-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get list questions used in stratified randomization"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves all questions used in stratified randomization designs in a specific study version.",
"operationId":"getStratificationFactors_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV2"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Updates a kit type in a study.",
"operationId":"updateKit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-kits-kitid-put"
},
"delete":{
"tags":[
"Designer/Kits APIs/Delete a kit"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Removes a kit type from a study.",
"operationId":"deleteKit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-kits-{kitId}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-kits-kitid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/kits/{kitId}/dispensings":{
"get":{
"tags":[
"Designer/Kits APIs/Get the dispensation data of a kit"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves dispensation information for a kit in a study.",
"operationId":"getDispensings_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-kits-{kitId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-kits-kitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/randomizationfactors":{
"get":{
"tags":[
"Designer/Study APIs/Study Randomization Factors/Get all active factors in a study"
],
"summary":"V2.0",
"description":"Retrieves a list of Study factors. You can retrieve this list by study mode and RandType.",
"operationId":"getRandFactors",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Study version mode to filter factors.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"type",
"in":"query",
"description":"Rand Algorithim to filter factors.",
"required":true,
"schema":{
"type":"string",
"default":"ALL",
"enum":[
"stratum",
"cohort",
"minimization",
"all"
]
},
"example":"all"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationFactorsV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-randomizationfactors-get"
}
},
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"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get list of randomization designs in a study version"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of all randomization designs for a study version.",
"operationId":"getRandomizations",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
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"items":{
"$ref":"#/components/schemas/RandomizationDtoV2"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV2"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-get"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization/Create randomization design"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Creates a new randomization design in a study version.",
"operationId":"addRandomization",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization payload used to create a randomization record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV2"
},
"examples":{
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"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV2"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get a randomization design"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a randomization design for a study version.",
"operationId":"getRandomization",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
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"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV2"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization/Update existing randomization design"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Updates an existing randomization design for a study version.",
"operationId":"updateRandomization",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
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{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"requestBody":{
"description":"Randomization payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
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},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV2"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-put"
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"delete":{
"tags":[
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],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Removes a randomization design from a study version within a study.",
"operationId":"deleteRandomization",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
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"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
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{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV2"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/strata/{stratumId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Study Strata/Get a stratum group"
],
"summary":"V2.0",
"description":"Retrieves a stratum group associated with a randomization design.",
"operationId":"getStratum_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"stratumId",
"in":"path",
"description":"Stratum ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"5C2D1E8F4A6B4D56A23C9F3A0C7D4E44"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StratumDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-{stratumId}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-stratumid-get"
},
"put":{
"tags":[
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],
"summary":"V2.0",
"description":"Updates a stratum group associated with a randomization design.",
"operationId":"updateStratum_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"stratumId",
"in":"path",
"description":"Stratum ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"5C2D1E8F4A6B4D56A23C9F3A0C7D4E44"
}
],
"requestBody":{
"description":"Stratum payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StratumDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StratumDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-{stratumId}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-stratumid-put"
},
"delete":{
"tags":[
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],
"summary":"V2.0",
"description":"Removes a stratum group associated with a randomization design.",
"operationId":"deleteStratum_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"stratumId",
"in":"path",
"description":"Stratum ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"5C2D1E8F4A6B4D56A23C9F3A0C7D4E44"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-{stratumId}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-stratumid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/strata/bulk":{
"put":{
"tags":[
"Designer/Randomization APIs/Study Strata/Update randomization cohort groups"
],
"summary":"V2.0",
"description":"Updates a list of cohort groups associated with a randomization design.",
"operationId":"updateStratums_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of stratum payloads with updated values for bulk update. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV2"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
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}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-bulk-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-bulk-put"
},
"post":{
"tags":[
"Designer/Randomization APIs/Study Strata/Create list of cohort groups"
],
"summary":"V2.0",
"description":"Creates a list of new cohort groups associated with a randomization design.",
"operationId":"saveStratums_4",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of stratum payloads used to create strata in bulk. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV2"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-bulk-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-bulk-post"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Study Strata/Delete cohort groups"
],
"summary":"V2.0",
"description":"Removes a list of cohort groups associated with a randomization design.",
"operationId":"deleteStratums_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of stratum payloads used to delete strata in bulk. Required.",
"content":{
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"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV2"
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},
"examples":{
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"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"$ref":"#/components/schemas/StratumDtoV2"
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},
"examples":{
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"description":"successResponse",
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{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-bulk-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-bulk-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/strata":{
"get":{
"tags":[
"Designer/Randomization APIs/Study Strata/Get list of all strata groups"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of all strata groups associated with a randomization design.",
"operationId":"getStrata_4",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV2"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-get"
},
"post":{
"tags":[
"Designer/Randomization APIs/Study Strata/Create randomization stratum group"
],
"summary":"V2.0",
"description":"Creates a new stratum group associated with a randomization design.",
"operationId":"saveStratums",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
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{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Stratum payload used to create a stratum. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StratumDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StratumDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-strata-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/studyDesign":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"requestBody":{
"description":"Array of study-version visit references used to fetch study design data. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV2"
}
},
"examples":{
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"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/studyMetadata":{
"get":{
"tags":[
"Designer/Study APIs/Study Metadata APIs/Get metadata of a specified study ID and study version"
],
"summary":"V2.0",
"description":"Retrieves metadata for a specified study ID and study version.",
"operationId":"getStudy_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"format",
"in":"query",
"description":"Format for the study metadata",
"required":true,
"schema":{
"type":"string",
"enum":[
"unique",
"casebook"
]
},
"example":"unique"
},
{
"name":"asofdate",
"in":"query",
"description":"Format for the study metadata",
"required":true,
"schema":{
"type":"string"
},
"example":"2024-01-15T10:30:00"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Study"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-studyMetadata-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-studymetadata-get"
}
},
"/ec-designer-svc/rest/v2.0/studies":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get a list of all studies"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of the latest studies in your system.",
"operationId":"queryStudies",
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-get"
},
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Add study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Add a study in your system.",
"operationId":"addStudy",
"requestBody":{
"description":"Study payload used to create a new study. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
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}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/visits/{visitId}/validate":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Check visit in study version"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Checks a specific visit in a study version placed in a Testing or Approved state.",
"operationId":"checkStudyVisit",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"boolean"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":true
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-visits-{visitId}-validate-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-visits-visitid-validate-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{targetId}/copystudyobjects":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Copy study design objects"
],
"summary":"V2.0",
"description":"Copies design objects from source to target study.",
"operationId":"copyStudyObjects_1",
"parameters":[
{
"name":"targetId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{targetId}-copystudyobjects-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-targetid-copystudyobjects-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{sourceStudyId}/copy":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create study copy template"
],
"summary":"V2.0",
"description":"Creates a template study for copying a to another study.",
"operationId":"createStudyCopy_1",
"parameters":[
{
"name":"sourceStudyId",
"in":"path",
"description":"Source study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyType",
"in":"query",
"description":"Study type. Allowed values: STANDARD (regular study), LIBRARY (reusable library study). Example: LIBRARY. Optional.",
"schema":{
"type":"string",
"default":"STANDARD"
},
"example":"STANDARD"
}
],
"requestBody":{
"description":"Details of study to copy",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{sourceStudyId}-copy-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-sourcestudyid-copy-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/allForms/coding":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all coding questions forms"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves all coding questions forms.",
"operationId":"fetchAllCodingQuestionsForms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-allForms-coding-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-allforms-coding-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/allForms":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all forms"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms.",
"operationId":"fetchAllForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-allForms-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-allforms-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get a list of study visits"
],
"summary":"V2.0",
"description":"Retrieves a list of visits in a study.",
"operationId":"queryVisits_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode to filter visits.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"sort",
"in":"query",
"description":"Get visits sorted Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitDTOV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-visits-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/approved/objectids":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get IDs of all artifacts in an approved study"
],
"summary":"V2.0",
"description":"Retrieves a list of IDs of all artifacts in a specified approved study. An artifact refers to anything that belongs to the study design, for example: forms, randomization, treatment arm, kits, etc.",
"operationId":"getApprovedIds",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"all",
"in":"query",
"description":"Include all study artifacts. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"arms",
"in":"query",
"description":"Include treatment arms. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"kits",
"in":"query",
"description":"Include kits. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"rands",
"in":"query",
"description":"Include randomization. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"forms",
"in":"query",
"description":"Include forms. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"items",
"in":"query",
"description":"Include items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"visits",
"in":"query",
"description":"Include visits. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"calculateddoses",
"in":"query",
"description":"Include calculated doses. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"cohorts",
"in":"query",
"description":"Include cohorts and cohort factors. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"inclEverApproved",
"in":"query",
"description":"Include study artifacts that were ever approved. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-approved-objectids-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-approved-objectids-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/{mode}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get a list of study forms"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of forms in a study.",
"operationId":"queryStudyForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"path",
"description":"Study mode to filter study forms.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormSummaryFlatDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-{mode}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-mode-forms-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/approved/choiceoptions":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get options of all choice items in the latest approved version"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves options of all choice items in the latest approved version.",
"operationId":"getLatestApprovedChoiceOptions",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-approved-choiceoptions-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-approved-choiceoptions-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/objectids":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get IDs of all artifacts in a study in a specific mode"
],
"summary":"V2.0",
"description":"Retrieves a list of IDs of all artifacts in a study in the specified mode: Testing, Approved and/or Archived. An artifact refers to anything that belongs to the study design, for example: forms, randomization, treatment arm, kits, etc.",
"operationId":"getObjectIds",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studymode",
"in":"query",
"description":"Study modes to search for artifacts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"array",
"items":{
"type":"string",
"enum":[
"design",
"test",
"training",
"active",
"all"
]
}
},
"example":"active"
},
{
"name":"archived",
"in":"query",
"description":"Include the archived versions of a study in a specified mode. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
},
{
"name":"all",
"in":"query",
"description":"Include all study artifacts. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"forms",
"in":"query",
"description":"Include forms. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"items",
"in":"query",
"description":"Include form items. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-objectids-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-objectids-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/statuses/{version}":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get status of latest study version"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves status of a specified study ID and study version.",
"operationId":"getStudy_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"version",
"in":"path",
"description":"Study version. Example: \"1.0.0.1\"",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-statuses-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-statuses-version-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/statuses":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses of a study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatuses",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-statuses-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-statuses-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/statusessummary":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses summary of a study"
],
"summary":"V2.0",
"description":"Retrieves all statuses summary for a specified study ID.",
"operationId":"getStudyStatusesSummary",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyStatusSummaryDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-statusessummary-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-statusessummary-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/library/{libraryId}/studyType/{studyType}/studyUses":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get summary of library studies usage"
],
"summary":"V2.0",
"description":"Retrieves all usage for library studies including info if some of the copies was modified",
"operationId":"queryApprovedStudiesLibraryUses_1",
"parameters":[
{
"name":"libraryId",
"in":"path",
"description":"Library ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"1C2D3E4F5A6B7C8D9E00112233445566"
},
{
"name":"studyType",
"in":"path",
"description":"Study type. Allowed values: STANDARD (regular study), LIBRARY (reusable library study). Example: LIBRARY.",
"required":true,
"schema":{
"type":"string"
},
"example":"STANDARD"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyLibraryObjectUseDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-library-{libraryId}-studyType-{studyType}-studyUses-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-library-libraryid-studytype-studytype-studyuses-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/forms/formitems":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all form items in a form"
],
"summary":"V2.0",
"description":"Retrieves all form items in a form by mode.",
"operationId":"queryBulkFormsItems",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Retrieves all form items in a form by mode.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"itemType",
"in":"query",
"description":"Form item types to include in the response. Optional.",
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"example":"instructionalText"
}
],
"requestBody":{
"description":"ItemIds for Choice Options Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov17"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-forms-formitems-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-forms-formitems-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/forms/{formId}/choiceoptions":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get options of all choice items by study mode and form ID(s)."
],
"summary":"V2.0",
"description":"Retrieves options of all choice items by study mode and form ID(s).",
"operationId":"queryChoiceOptions",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Retrieves all form items in a form by mode.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"allowHiddenOptions",
"in":"query",
"description":"Include hidden choice options in the response. Optional.",
"schema":{
"type":"boolean"
},
"example":false
}
],
"requestBody":{
"description":"ItemIds for Choice Options Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-forms-{formId}-choiceoptions-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-forms-formid-choiceoptions-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/forms/{formId}/formitems":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all form items in a form by form ID"
],
"summary":"V2.0",
"description":"Retrieves all form items in a form by ID.",
"operationId":"queryFormItems",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"mode",
"in":"query",
"description":"Retrieves all form items in a form by mode.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"itemType",
"in":"query",
"description":"Form item types to include in the response. Optional.",
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"example":"instructionalText"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov17"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-forms-{formId}-formitems-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-forms-formid-formitems-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{targetStudyId}/retryCopyStudy":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create study copy template"
],
"summary":"V2.0",
"description":"Creates a template study for copying a to another study.",
"operationId":"retryCopyStudy_1",
"parameters":[
{
"name":"targetStudyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{targetStudyId}-retryCopyStudy-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-targetstudyid-retrycopystudy-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/updateCopyStudyStatus":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Update study copy status"
],
"summary":"V2.0",
"description":"Update study copy status for the copied study",
"operationId":"updateCopyStudyStatus_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Copies study status from source to target study.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyCopyStatusDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyCopyStatusDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-updateCopyStudyStatus-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-updatecopystudystatus-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}":{
"put":{
"tags":[
"Designer/Study APIs/Study Actions/Update existing study"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Updates an existing study.",
"operationId":"updateStudy",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-put"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/studyversionobjects/formitems":{
"get":{
"tags":[
"Designer/Study Version APIs/Get items with ASVs within date range"
],
"summary":"V2.0",
"description":"Retrieves items with ASVs within a given date range.",
"operationId":"get_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"fromDate",
"in":"query",
"description":"Start date-time (yyyy-MM-dd'T'HH:mm:ss) for filtering study versions. Optional.",
"schema":{
"type":"string"
},
"example":"2024-01-01T00:00:00"
},
{
"name":"toDate",
"in":"query",
"description":"End date-time (yyyy-MM-dd'T'HH:mm:ss) for filtering study versions. Optional.",
"schema":{
"type":"string"
},
"example":"2024-12-31T23:59:59"
},
{
"name":"offset",
"in":"query",
"description":"Study version index to start from. Optional.",
"schema":{
"type":"integer",
"format":"int32",
"default":0
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Number of study versions to return. Optional.",
"schema":{
"type":"integer",
"format":"int32",
"default":1000
},
"example":1000
},
{
"name":"formCategory",
"in":"query",
"description":"Form category to filter form items by. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionFormItemDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-studyversionobjects-formitems-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-studyversionobjects-formitems-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}":{
"delete":{
"tags":[
"Designer/Versions APIs/Delete study version"
],
"summary":"V2.0",
"description":"Removes a study's version.",
"operationId":"deleteStudy",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"The Version ID",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
},
{
"name":"isCopy",
"in":"query",
"description":"Indicates copy study Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions":{
"get":{
"tags":[
"Designer/Versions APIs/Get list of study versions"
],
"summary":"V2.0",
"description":"Retrieves list of versions for a specified study.",
"operationId":"getVersions",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"sort",
"in":"query",
"description":"Sorts the response by study version start date when set to true. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"nondraftonly",
"in":"query",
"description":"Returns non-draft versions only when set to true. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VersionDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
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],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV2"
},
"examples":{
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"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV2"
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},
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"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-post"
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},
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"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get study visit schedule"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule in a study.",
"operationId":"getVisitSchedule_8",
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{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
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"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
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{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-schedule-get"
},
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"tags":[
"Designer/Visit APIs/Visit Schedule/Update visit schedule"
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"summary":"V2.0",
"description":"Deprecated: Use this other API instead: /{visitid}/schedule/{fromEventRefId} - Updates visit schedule in your study.",
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"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
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"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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{
"name":"visitid",
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"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
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],
"requestBody":{
"description":"Visit schedule payload with updated values. Required.",
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"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
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"examples":{
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"description":"requestExample",
"value":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
},
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"200":{
"description":"Successful operation.",
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"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
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}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-schedule-put"
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"tags":[
"Designer/Visit APIs/Visit Schedule/Create visit schedule"
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"summary":"V2.0",
"description":"/{visitid}/schedule/{fromEventRefId} - Creates a visit schedule for your study.",
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"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
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"example":"F054C951EB74443C93716CA714AB686E"
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit schedule payload used to create a schedule entry. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
},
"examples":{
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"description":"requestExample",
"value":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
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"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
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}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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"$ref":"#/components/schemas/ErrorResponseData"
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}
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}
},
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"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-schedule-post"
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"tags":[
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"summary":"V2.0",
"description":"Deprecated: Use this other API instead: /{visitid}/schedule/{fromEventRefId} - Removes visit schedule from your study.",
"operationId":"clearVisitSchedule",
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{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
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"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
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"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV1"
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"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
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}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-schedule-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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{
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"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
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{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV2"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV2"
},
"examples":{
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"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV2"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-put"
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"delete":{
"tags":[
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],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/visitschedules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule of a study.",
"operationId":"getVisitSchedule_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"unscheduledVisits",
"in":"query",
"description":"Include unscheduled visit or not.",
"required":true,
"schema":{
"type":"string",
"default":"include"
},
"example":"include"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visitschedules-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visitschedules-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/branches":{
"get":{
"tags":[
"Designer/Branch APIs/Get a list of study branches"
],
"summary":"V2.0",
"description":"Retrieves a list of branches in a study.",
"operationId":"getBranches",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-branches-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-branches-get"
},
"post":{
"tags":[
"Designer/Branch APIs/Add a branch"
],
"summary":"V2.0",
"description":"Adds a branch in your study.",
"operationId":"addBranch",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Visit branch payload used to create a branch. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-branches-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-branches-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/branches/{branchid}/copyBranch":{
"post":{
"tags":[
"Designer/Branch APIs/Copy a branch"
],
"summary":"V2.0",
"description":"Adds a copied branch in your study.",
"operationId":"copyBranch_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"branchid",
"in":"path",
"description":"Visit branch ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-branches-{branchid}-copyBranch-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-branches-branchid-copybranch-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/branches/{branchid}":{
"get":{
"tags":[
"Designer/Branch APIs/Get study branch"
],
"summary":"V2.0",
"description":"Retrieves a branch in a study.",
"operationId":"getBranch",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"branchid",
"in":"path",
"description":"Visit branch ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-branches-{branchid}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-branches-branchid-get"
},
"put":{
"tags":[
"Designer/Branch APIs/Update a branch"
],
"summary":"V2.0",
"description":"Updates a branch in your study.",
"operationId":"updateBranch",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"branchid",
"in":"path",
"description":"Visit branch ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Visit branch payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-branches-{branchid}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-branches-branchid-put"
},
"delete":{
"tags":[
"Designer/Branch APIs/Delete a branch"
],
"summary":"V2.0",
"description":"Removes a branch from your study.",
"operationId":"deleteBranch",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"branchid",
"in":"path",
"description":"Visit branch ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-branches-{branchid}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-branches-branchid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/visitsforms":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Query visits, forms, and questions"
],
"summary":"V2.0",
"description":"Retrieves visits with forms and question metadata for the selected study versions. Use `/v17.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms` and related v17.0 visit/form endpoints for active behavior and metadata.",
"operationId":"queryVisitsForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"versions",
"in":"query",
"description":"Comma-separated study version numbers to filter by. Optional; when omitted, the latest active version data is returned.",
"schema":{
"type":"string"
},
"example":"1,2"
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form item type to exclude from the question list. Optional. Allowed value: `instructionalText`.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsFormsQuestionsDto"
}
},
"examples":{
"queryVisitsFormsV2Response":{
"description":"queryVisitsFormsV2Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"visitName":"Screening",
"forms":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics"
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-visitsforms-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-visitsforms-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/visitsMetadata":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Metadata/Get the metadata of specified visits by study ID and study version"
],
"summary":"V2.0",
"description":"Retrieves metadata for specified visits in different study versions.",
"operationId":"queryVisitsFormsAsOfDate_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"asofdate",
"in":"query",
"description":"Format for the study metadata",
"required":true,
"schema":{
"type":"string"
},
"example":"2024-01-15T10:30:00"
}
],
"requestBody":{
"description":"Array of study-version visit references used to build metadata output. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV2"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ODM1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-visitsMetadata-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-visitsmetadata-post"
}
},
"/ec-designer-svc/rest/v2.0/report/{reportName}":{
"post":{
"tags":[
"Designer/Reporting APIs/Generate study design reports"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves study-design data in paginated format based on the selected report name and filters. Access requires the StudyDesignReportPost permission.",
"operationId":"generateDesignerReport",
"parameters":[
{
"name":"reportName",
"in":"path",
"description":"The report section name",
"required":true,
"schema":{
"type":"string",
"enum":[
"STUDY_DESIGN_SUMMARY",
"DESIGNER_RANDOMIZATION_SECTION",
"DESIGNER_RANDOMIZATION_TREATMENT_ARMS",
"DESIGNER_KITS_SECTION",
"DESIGNER_KIT_DISPENSATION_SECTION"
]
},
"example":"STUDY_DESIGN_SUMMARY"
},
{
"name":"studyId",
"in":"query",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Search criteria used to generate the report. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"400":{
"description":"'studyId is a mandatory filter criteria', 'studyVersion is a mandatory filter criteria', 'Filter Criteria can not be empty', 'Invalid Offset', 'Invalid Limit', 'Missing Request Body'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-report-{reportName}-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-report-reportname-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/design/visits/{visitId}/validate/assign/randomization/{randomizationId}":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Validate assigning randomization"
],
"summary":"V3.0",
"description":"Validates assigning randomization design to a visit.",
"operationId":"validateAssignRandomization_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomizationId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"branchIds",
"in":"query",
"description":"Branch IDs in the visits schedule",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-design-visits-{visitId}-validate-assign-randomization-{randomizationId}-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-design-visits-visitid-validate-assign-randomization-randomizationid-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get kits from all study versions in Testing, Approved and Archived"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits for all study versions in Testing, Approved and Archived states.",
"operationId":"getStudyNonDraftKitDesc_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode to filter kits.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDescDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-kits-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/arms/{armId}/dispensings":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/Get list of treatment arm dispensations in a study version"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of treatment arm dispensations for a study version.",
"operationId":"getDispensings_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Treatment arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-arms-{armId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-arms-armid-dispensings-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Get list of dispensation visits in a study version"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves list of all dispensation visits in a study version.",
"operationId":"getDispensings_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-dispensings-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Update list of dispensation visits"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates list of dispensation visits in a study version to create new visits, update existing ones or delete deprecated visits.",
"operationId":"updateDispensings_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randVisitId",
"in":"query",
"description":"Visit ID where randomization was assigned (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"default":"empty"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of ArmKitVisit payloads used to update existing study version dispensings. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV3"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-dispensings-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-dispensings-put"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_27",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV3"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form to add",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV3"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV3"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/forms/visits":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Add form to visits"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Adds a form to multiple visits for a study version. Use the latest supported version of this endpoint in v17.0 for current behavior and metadata.",
"operationId":"addFormToVisits_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of form visits",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitsDtoV1"
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"addFormToVisitsV3Response":{
"description":"addFormToVisitsV3Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-visits-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-visits-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV3"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV3"
},
"examples":{
"updateFormV3Request":{
"description":"updateFormV3Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV3"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV3"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List stratification factors"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves stratification factors used in randomization for forms. Use the latest supported version of this endpoint in v17.0 for current behavior and metadata.",
"operationId":"getStratificationFactors_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV3"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values: STANDARD, TITRATION, ALL.",
"schema":{
"type":"string"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/kits/{kitId}/dispensings":{
"get":{
"tags":[
"Designer/Kits APIs/Get the dispensation data of a kit"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves dispensation information for a kit in a study.",
"operationId":"getDispensings_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-kits-{kitId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-kits-kitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates a kit type in a study.",
"operationId":"updateKit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-kits-kitid-put"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/kits/{kitId}/blindedInfo":{
"get":{
"tags":[
"Designer/Kits APIs/Get blinded data on a kit"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKitBlindedInfo_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used for blinded output filtering. Optional.",
"schema":{
"type":"string",
"default":"test"
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-kits-{kitId}-blindedInfo-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-kits-kitid-blindedinfo-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/randomizations":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get list of randomization designs in a study version"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of all randomization designs for a study version.",
"operationId":"getRandomizations_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-get"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization/Create randomization design"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Creates a new randomization design in a study version.",
"operationId":"addRandomization_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization payload used to create a randomization record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/randomizations/{randomId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get a randomization design"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves a randomization design for a study version.",
"operationId":"getRandomization_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization/Update existing randomization design"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates an existing randomization design for a study version.",
"operationId":"updateRandomization_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"branchIds",
"in":"query",
"description":"Branch IDs in the visits schedule",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Randomization payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-put"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization/Delete randomization design"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Removes a randomization design from a study version within a study.",
"operationId":"deleteRandomization_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-delete"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/strata":{
"get":{
"tags":[
"Designer/Randomization APIs/Study Strata/Get list of all strata groups"
],
"summary":"V3.0",
"description":"Retrieves a list of all strata groups associated with a randomization design.",
"operationId":"getStrata_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-strata-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/studyDesign":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"requestBody":{
"description":"Array of study-version visit references used to fetch study design data. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV1"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v3.0/studies":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get a list of all studies"
],
"summary":"V3.0",
"description":"Retrieves a list of the latest studies in your system.",
"operationId":"queryStudies_1",
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-get"
},
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Add study"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Add a study in your system.",
"operationId":"addStudy_1",
"parameters":[
{
"name":"studyType",
"in":"query",
"description":"Study type. Allowed values: STANDARD (regular study), LIBRARY (reusable library study). Example: LIBRARY. Optional.",
"schema":{
"type":"string",
"default":"STANDARD"
},
"example":"STANDARD"
}
],
"requestBody":{
"description":"Study payload used to create a new study. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/visits/{visitId}/validate":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Check visit in study version"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Checks a specific visit in a study version placed in a Testing or Approved state.",
"operationId":"checkStudyVisit_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"visitId",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"boolean"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":true
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-visits-{visitId}-validate-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-visits-visitid-validate-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/allForms/coding":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all coding questions forms"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves all coding questions forms.",
"operationId":"fetchAllCodingQuestionsForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-allForms-coding-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-allforms-coding-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/allForms":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all forms"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms.",
"operationId":"fetchAllForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-allForms-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-allforms-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/{mode}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get a list of study forms"
],
"summary":"V3.0",
"description":"Retrieves a list of forms in a study.",
"operationId":"queryStudyForms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"path",
"description":"Study mode to filter study forms.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Form Summary DTO V3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-{mode}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-mode-forms-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/approved/choiceoptions":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get options of all choice items in the latest approved version"
],
"summary":"V3.0",
"description":"Retrieves options of all choice items in the latest approved version.",
"operationId":"getLatestApprovedChoiceOptions_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
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}
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},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-approved-choiceoptions-get",
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"/ec-designer-svc/rest/v3.0/studies/{studyId}/statuses/{version}":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get status of latest study version"
],
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"description":"Deprecated: Use latest version instead. Retrieves status of a specified study ID and study version.",
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"parameters":[
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"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
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{
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"description":"Study version. Example: \"1.0.0.1\"",
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"schema":{
"type":"string"
},
"example":"1.0.0.1"
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],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
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"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
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}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-statuses-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-statuses-version-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/statuses":{
"get":{
"tags":[
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],
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"description":"Deprecated: Use latest version instead. Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatuses_1",
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"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"schema":{
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"items":{
"$ref":"#/components/schemas/StudyDtoV3"
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},
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"value":{
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{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
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"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
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"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-statuses-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-statuses-get"
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},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/statusessummary":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses summary of a study"
],
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"description":"Deprecated: Use latest version instead. Retrieves all statuses for a specified study ID.",
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"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
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"schema":{
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"format":"uuid"
},
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{
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"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
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"default":""
},
"example":"draft"
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],
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"items":{
"$ref":"#/components/schemas/StudyStatusSummaryDtoV3"
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"examples":{
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}
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}
}
}
}
}
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"content":{
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}
}
},
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"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
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"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
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"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-statusessummary-get",
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}
},
"/ec-designer-svc/rest/v3.0/studies/library":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get a list of all library studies"
],
"summary":"V3.0",
"description":"Retrieves a list of the latest library studies in your system.",
"operationId":"queryLibraryStudies_1",
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"items":{
"$ref":"#/components/schemas/StudyDtoV5"
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{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-library-get",
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},
"/ec-designer-svc/rest/v3.0/studies/{studyId}":{
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"tags":[
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"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates an existing study.",
"operationId":"updateStudy_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
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"description":"Successful operation.",
"content":{
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"description":"successResponse",
"value":{
"result":{
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"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
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"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
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"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-put"
}
},
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"get":{
"tags":[
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],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV3"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
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],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
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"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
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"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"schema":{
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"items":{
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{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
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"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
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"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/visits/{visitid}/schedule/{fromEventRefId}":{
"put":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Update visit schedule from event"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates visit schedule in your study.",
"operationId":"updateVisitSchedule_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"fromEventRefId",
"in":"path",
"description":"From Event Ref ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"4D56A23C9F3A0C7D4E117A4D3C2B1E8F"
}
],
"requestBody":{
"description":"Visit schedule payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV3"
},
"examples":{
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"description":"requestExample",
"value":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV3"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
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"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-{fromEventRefId}-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-schedule-fromeventrefid-put"
},
"post":{
"tags":[
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],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Creates a visit schedule for your study.",
"operationId":"createVisitSchedule_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"fromEventRefId",
"in":"path",
"description":"From Event Ref ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"4D56A23C9F3A0C7D4E117A4D3C2B1E8F"
}
],
"requestBody":{
"description":"Visit schedule payload used to create a schedule entry. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV3"
},
"examples":{
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"description":"requestExample",
"value":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
},
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},
"responses":{
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"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV3"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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"schema":{
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}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-{fromEventRefId}-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-schedule-fromeventrefid-post"
},
"delete":{
"tags":[
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],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Removes visit schedule from your study.",
"operationId":"clearVisitSchedule_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"fromEventRefId",
"in":"path",
"description":"From Event Ref ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"4D56A23C9F3A0C7D4E117A4D3C2B1E8F"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-{fromEventRefId}-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-schedule-fromeventrefid-delete"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/visits/{visitid}/schedule":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get study visit schedule"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule in a study.",
"operationId":"getVisitSchedule_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-schedule-get"
}
},
"/ec-designer-svc/rest/v3.0/report/{reportName}":{
"post":{
"tags":[
"Designer/Reporting APIs/Generate study design reports"
],
"summary":"V3.0",
"description":"Generates a designer report for the requested report type using the provided search criteria.",
"operationId":"generateDesignerReport_1",
"parameters":[
{
"name":"reportName",
"in":"path",
"description":"The report section name",
"required":true,
"schema":{
"type":"string",
"enum":[
"DESIGNER_RANDOMIZATION_SECTION",
"DESIGNER_KIT_DISPENSATION_SECTION",
"DESIGNER_KITS_SECTION"
]
},
"example":"DESIGNER_RANDOMIZATION_SECTION"
},
{
"name":"studyId",
"in":"query",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Search criteria used to generate the report. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/SearchSpecs"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/PaginatedResponseDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"400":{
"description":"'studyId is a mandatory filter criteria', 'studyVersion is a mandatory filter criteria', 'Filter Criteria can not be empty', 'Invalid Offset', 'Invalid Limit', 'Missing Request Body'",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerResponse"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-report-{reportName}-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-report-reportname-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Return the lite visit design response when set to true. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/arms/{armId}/dispensings":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/Get list of treatment arm dispensations in a study version"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of treatment arm dispensations for a study version.",
"operationId":"getDispensings_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Treatment arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-arms-{armId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-arms-armid-dispensings-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Get list of dispensation visits in a study version"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves list of all dispensation visits in a study version.",
"operationId":"getDispensings_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-dispensings-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Update list of dispensation visits"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Updates list of dispensation visits in a study version to create new visits, update existing ones or delete deprecated visits.",
"operationId":"updateDispensings_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randVisitId",
"in":"query",
"description":"Visit ID where randomization was assigned (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"default":"empty"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of ArmKitVisit payloads used to update existing study version dispensings. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV4"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-dispensings-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-dispensings-put"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_28",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV4"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"V4.0",
"description":" Adds a form in a study version.",
"operationId":"addForm_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form to add",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV4"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV4"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/forms/visits":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Add form to visits"
],
"summary":"V4.0",
"description":"Adds a form to multiple visits for a study version. Use the latest supported version of this endpoint in v17.0 for current behavior and metadata.",
"operationId":"addFormToVisits_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of form visits",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitsDtoV4"
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"addFormToVisitsV4Response":{
"description":"addFormToVisitsV4Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-visits-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-visits-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV4"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV4"
},
"examples":{
"updateFormV4Request":{
"description":"updateFormV4Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV4"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV4"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List stratification factors"
],
"summary":"V4.0",
"description":"Retrieves stratification factors used in randomization for forms. Use the latest supported version of this endpoint in v17.0 for current behavior and metadata.",
"operationId":"getStratificationFactors_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV4"
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits_2",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit_2",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/kits/{kitId}/dispensings":{
"get":{
"tags":[
"Designer/Kits APIs/Get the dispensation data of a kit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves dispensation information for a kit in a study.",
"operationId":"getDispensings_13",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-kits-{kitId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-kits-kitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit_2",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Updates a kit type in a study.",
"operationId":"updateKit_2",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-kits-kitid-put"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/kits/{kitId}/blindedInfo":{
"get":{
"tags":[
"Designer/Kits APIs/Get blinded data on a kit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKitBlindedInfo",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used for blinded output filtering. Optional.",
"schema":{
"type":"string",
"default":"test"
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-kits-{kitId}-blindedInfo-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-kits-kitid-blindedinfo-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/randomizations":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get list of randomization designs in a study version"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of all randomization designs for a study version.",
"operationId":"getRandomizations_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-randomizations-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-randomizations-get"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization/Create randomization design"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Creates a new randomization design in a study version.",
"operationId":"addRandomization_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization payload used to create a randomization record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-randomizations-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-randomizations-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/randomizations/{randomId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get a randomization design"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves a randomization design for a study version.",
"operationId":"getRandomization_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-randomizations-randomid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization/Update existing randomization design"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Updates an existing randomization design for a study version.",
"operationId":"updateRandomization_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"branchIds",
"in":"query",
"description":"Branch IDs in the visits schedule",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Randomization payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-randomizations-randomid-put"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization/Delete randomization design"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Removes a randomization design from a study version within a study.",
"operationId":"deleteRandomization_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-delete",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-randomizations-randomid-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/studyDesign":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode.",
"operationId":"getStudyDesignByMode_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"modes",
"in":"query",
"description":"Study mode filters. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"array",
"items":{
"type":"string",
"default":"all",
"enum":[
"all",
"test",
"training",
"active"
]
}
},
"example":"design"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"active",
"enum":[
"test",
"active"
]
},
"example":"active"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-studyDesign-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-studydesign-get"
},
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
}
],
"requestBody":{
"description":"Array of study-version visit references used to fetch study design data. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV4"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v4.0/studies":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Add study"
],
"summary":"V4.0",
"description":"Add a study in your system.",
"operationId":"addStudy_2",
"parameters":[
{
"name":"studyType",
"in":"query",
"description":"Study type. Allowed values: STANDARD (regular study), LIBRARY (reusable library study). Example: LIBRARY. Optional.",
"schema":{
"type":"string",
"default":"STANDARD"
},
"example":"STANDARD"
}
],
"requestBody":{
"description":"Study payload used to create a new study. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV6"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV6"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/visits/{visitId}/validate":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Check visit in study version"
],
"summary":"V4.0",
"description":"Checks a specific visit in a study version placed in a Testing or Approved state.",
"operationId":"checkStudyVisit_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"visitId",
"in":"path",
"description":"Visit identifier",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"boolean"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":true
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-visits-{visitId}-validate-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-visits-visitid-validate-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/allForms/coding":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all coding questions forms"
],
"summary":"V4.0",
"description":"Retrieves all coding questions forms.",
"operationId":"fetchAllCodingQuestionsForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-allForms-coding-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-allforms-coding-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/allForms":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all forms"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms.",
"operationId":"fetchAllForms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"excludeBaseStudyVersion",
"in":"query",
"description":"Exclude forms from the base study version when true. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
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"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-allForms-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-allforms-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/studyversionobjects/paginated":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects in a paginated format"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getPaginatedStudyVersionObjects_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"offset",
"in":"query",
"description":"Study version index to start from",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Number of study versions to return",
"schema":{
"type":"string",
"default":"1000"
},
"example":1000
},
{
"name":"order",
"in":"query",
"description":"Order in which study versions to be returned",
"schema":{
"type":"string",
"default":"asc"
},
"example":"asc"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-studyversionobjects-paginated-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-studyversionobjects-paginated-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/statuses/{version}":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get status of latest study version"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves status of a specified study ID and study version.",
"operationId":"getStudy_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"version",
"in":"path",
"description":"Study version. Example: 1.0.0.1",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV4"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-statuses-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-statuses-version-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/statuses":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses of a study"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatuses_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV4"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-statuses-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-statuses-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/statusessummary":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses summary of a study"
],
"summary":"V4.0",
"description":"Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatusesSummary_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyStatusSummaryDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-statusessummary-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-statusessummary-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects for a study version"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visits/{visitid}/schedule/{fromEventRefId}":{
"put":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Update visit schedule from event"
],
"summary":"V4.0",
"description":"Updates visit schedule in your study.",
"operationId":"updateVisitSchedule_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"fromEventRefId",
"in":"path",
"description":"From Event Ref ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"4D56A23C9F3A0C7D4E117A4D3C2B1E8F"
}
],
"requestBody":{
"description":"Visit schedule payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-{fromEventRefId}-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-schedule-fromeventrefid-put"
},
"post":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Create visit schedule from event"
],
"summary":"V4.0",
"description":"Creates a visit schedule for your study.",
"operationId":"createVisitSchedule_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"fromEventRefId",
"in":"path",
"description":"From Event Ref ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"4D56A23C9F3A0C7D4E117A4D3C2B1E8F"
}
],
"requestBody":{
"description":"Visit schedule payload used to create a schedule entry. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-{fromEventRefId}-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-schedule-fromeventrefid-post"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Clear visit schedule from event"
],
"summary":"V4.0",
"description":"Removes visit schedule from your study.",
"operationId":"clearVisitSchedule_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"fromEventRefId",
"in":"path",
"description":"From Event Ref ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"4D56A23C9F3A0C7D4E117A4D3C2B1E8F"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-{fromEventRefId}-delete",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-schedule-fromeventrefid-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_14",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visits/{visitid}/schedule":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get study visit schedule"
],
"summary":"V4.0",
"description":"Retrieves the visit schedule in a study.",
"operationId":"getVisitSchedule_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyEventScheduleDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-schedule-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-schedule-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Return the lite visit design response when set to true. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDesignDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get kits from all study versions in Testing, Approved and Archived"
],
"summary":"V5.0",
"description":"Retrieves list of kits for all study versions in Testing, Approved and Archived states.",
"operationId":"getStudyNonDraftKitDesc_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to filter kits or titration. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"kitType",
"in":"query",
"description":"Kit type, such as standard, titration, device or all, to filter by. Optional.",
"schema":{
"type":"string",
"default":"all",
"enum":[
"standard",
"device",
"titration",
"all"
]
},
"example":"all"
},
{
"name":"unblinded",
"in":"query",
"description":"Indicates whether unblinded fields are returned for users who have the OrsUnblinded permission. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDescDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-kits-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/arms/{armId}/dispensings":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/Get list of treatment arm dispensations in a study version"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of treatment arm dispensations for a study version.",
"operationId":"getDispensings_15",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Treatment arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, device, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-arms-{armId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-arms-armid-dispensings-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Get list of dispensation visits in a study version"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves list of all dispensation visits in a study version.",
"operationId":"getDispensings_16",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-dispensings-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Update list of dispensation visits"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Updates list of dispensation visits in a study version to create new visits, update existing ones or delete deprecated visits.",
"operationId":"updateDispensings_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randVisitId",
"in":"query",
"description":"Visit ID where randomization was assigned (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"default":"empty"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of ArmKitVisit payloads used to update existing study version dispensings. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV4"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-dispensings-put",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-dispensings-put"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/forms":{
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV5"
},
"examples":{
"createFormV5Request":{
"description":"createFormV5Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV5"
},
"examples":{
"createFormV5Response":{
"description":"createFormV5Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV5"
},
"examples":{
"updateFormV5Request":{
"description":"updateFormV5Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV5"
},
"examples":{
"updateFormV5Response":{
"description":"updateFormV5Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-put"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits_3",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit_3",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/kits/{kitId}/dispensings":{
"get":{
"tags":[
"Designer/Kits APIs/Get the dispensation data of a kit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves dispensation information for a kit in a study.",
"operationId":"getDispensings_17",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-kits-{kitId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-kits-kitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit_3",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Updates a kit type in a study.",
"operationId":"updateKit_3",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-kits-kitid-put"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/kits/{kitId}/blindedInfo":{
"get":{
"tags":[
"Designer/Kits APIs/Get blinded data on a kit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKitBlindedInfo_1",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used for blinded output filtering. Optional.",
"schema":{
"type":"string",
"default":"test"
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV6"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-kits-{kitId}-blindedInfo-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-kits-kitid-blindedinfo-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/latest/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get latest study version objects"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getStudyVersionObjects",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"modes",
"in":"query",
"description":"Study modes to search for artifacts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"schema":{
"type":"array",
"items":{
"type":"string",
"enum":[
"design",
"test",
"training",
"active",
"all"
]
}
},
"example":"design"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-latest-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-latest-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/randomizations":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get list of randomization designs in a study version"
],
"summary":"V5.0",
"description":"Retrieves a list of all randomization designs for a study version.",
"operationId":"getRandomizations_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-randomizations-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-randomizations-get"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization/Create randomization design"
],
"summary":"V5.0",
"description":"Creates a new randomization design in a study version.",
"operationId":"addRandomization_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization payload used to create a randomization record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-randomizations-post",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-randomizations-post"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/randomizations/{randomId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization/Get a randomization design"
],
"summary":"V5.0",
"description":"Retrieves a randomization design for a study version.",
"operationId":"getRandomization_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"visitDesignPathIds",
"in":"query",
"description":"Comma-separated list of Visit Design Path IDs (UUIDs) to scope the randomization retrieval and this parameter is applicable for algorithm type None only Optional.",
"schema":{
"type":"string"
},
"example":"3BCE1EE7AD7B4625B76876A49A7144CF,4BCE1EE7AD7B4625B76876A49A7144CE,7BCE1EE7AD7B4625B76876A49A7144CD"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-randomizations-randomid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization/Update existing randomization design"
],
"summary":"V5.0",
"description":"Updates an existing randomization design for a study version.",
"operationId":"updateRandomization_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"branchIds",
"in":"query",
"description":"Branch IDs in the visits schedule",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
}
],
"requestBody":{
"description":"Randomization payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-put",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-randomizations-randomid-put"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization/Delete randomization design"
],
"summary":"V5.0",
"description":"Removes a randomization design from a study version within a study.",
"operationId":"deleteRandomization_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randomId",
"in":"path",
"description":"Randomization ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RandomizationDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-delete",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-randomizations-randomid-delete"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/studyDesign":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode.",
"operationId":"getStudyDesignByMode",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"modes",
"in":"query",
"description":"Study mode filters. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"array",
"items":{
"type":"string",
"default":"all",
"enum":[
"all",
"test",
"training",
"active"
]
}
},
"example":"design"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"active",
"enum":[
"test",
"active"
]
},
"example":"active"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-studyDesign-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-studydesign-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/allForms":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all forms"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms.",
"operationId":"fetchAllForms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-allForms-post",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-allforms-post"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/studyversionobjects/paginated":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects in a paginated format"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getPaginatedStudyVersionObjects",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"offset",
"in":"query",
"description":"Study version index to start from",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Number of study versions to return",
"schema":{
"type":"string",
"default":"1000"
},
"example":1000
},
{
"name":"order",
"in":"query",
"description":"Order in which study versions to be returned",
"schema":{
"type":"string",
"default":"asc"
},
"example":"asc"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-studyversionobjects-paginated-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-studyversionobjects-paginated-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/statuses/{version}":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get status of latest study version"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves status of a specified study ID and study version.",
"operationId":"getStudy_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"version",
"in":"path",
"description":"Study version. Example: 1.0.0.1",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-statuses-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-statuses-version-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/statuses":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses of a study"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatuses_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-statuses-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-statuses-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects"
],
"summary":"V5.0",
"description":"Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/AllStudyVersionsObjectsDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}":{
"put":{
"tags":[
"Designer/Study APIs/Study Actions/Update existing study"
],
"summary":"V5.0",
"description":"Updates an existing study.",
"operationId":"updateStudy_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Study payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV7"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV7"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-put",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-put"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/studyversionobjects/iprDetails":{
"get":{
"tags":[
"Designer/Study Version APIs/Get IPR details"
],
"summary":"V5.0",
"description":"Get IPR details.",
"operationId":"getAdditionalInfoForIPRs_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to fetch IPR details. Optional. Allowed values: test, training, active, design.",
"schema":{
"type":"string",
"default":"test"
},
"example":"test"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-studyversionobjects-iprDetails-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-studyversionobjects-iprdetails-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects for a study version"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
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"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_18",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Return the lite visit design response when set to true. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/arms/{armId}/dispensings":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/Get list of treatment arm dispensations in a study version"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of treatment arm dispensations for a study version.",
"operationId":"getDispensings_19",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Treatment arm ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, device, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-arms-{armId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-arms-armid-dispensings-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Get list of dispensation visits in a study version"
],
"summary":"V6.0",
"description":"Retrieves list of all dispensation visits in a study version.",
"operationId":"getDispensings_20",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-dispensings-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Dispensation Visits/Update list of dispensation visits"
],
"summary":"V6.0",
"description":"Updates list of dispensation visits in a study version to create new visits, update existing ones or delete deprecated visits.",
"operationId":"updateDispensings_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"randVisitId",
"in":"query",
"description":"Visit ID where randomization was assigned (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"default":"empty"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of ArmKitVisit payloads used to update existing study version dispensings. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV4"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-dispensings-put",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-dispensings-put"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_30",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV7"
}
},
"examples":{
"listFormsV6Response":{
"description":"listFormsV6Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV7"
},
"examples":{
"createFormV6Request":{
"description":"createFormV6Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV7"
},
"examples":{
"createFormV6Response":{
"description":"createFormV6Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV7"
},
"examples":{
"getFormV6Response":{
"description":"getFormV6Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV7"
},
"examples":{
"updateFormV6Request":{
"description":"updateFormV6Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV7"
},
"examples":{
"updateFormV6Response":{
"description":"updateFormV6Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV7"
},
"examples":{
"deleteFormV6Response":{
"description":"deleteFormV6Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits_4",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit_4",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV6"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV6"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit_4",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV6"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Updates a kit type in a study.",
"operationId":"updateKit_4",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV6"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV6"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-kits-kitid-put"
},
"delete":{
"tags":[
"Designer/Kits APIs/Delete a kit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Removes a kit type from a study.",
"operationId":"deleteKit_1",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-kits-{kitId}-delete",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-kits-kitid-delete"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/kits/{kitId}/dispensings":{
"get":{
"tags":[
"Designer/Kits APIs/Get the dispensation data of a kit"
],
"summary":"V6.0",
"description":"Retrieves dispensation information for a kit in a study.",
"operationId":"getDispensings_21",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-kits-{kitId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-kits-kitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/kits/{kitId}/blindedInfo":{
"get":{
"tags":[
"Designer/Kits APIs/Get blinded data on a kit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKitBlindedInfo_2",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"STANDARD"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used for blinded output filtering. Optional.",
"schema":{
"type":"string",
"default":"test"
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV7"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-kits-{kitId}-blindedInfo-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-kits-kitid-blindedinfo-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/latest/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get latest study version objects"
],
"summary":"V6.0",
"description":"Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"modes",
"in":"query",
"description":"Study modes to search for artifacts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"schema":{
"type":"array",
"items":{
"type":"string",
"enum":[
"design",
"test",
"training",
"active",
"all"
]
}
},
"example":"design"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-latest-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-latest-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/studyDesign":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode.",
"operationId":"getStudyDesignByMode_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"test",
"enum":[
"test",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-studyDesign-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-studydesign-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/allForms":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all forms"
],
"summary":"V6.0",
"description":"Retrieves all forms.",
"operationId":"fetchAllForms_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"Study versions to include. Optional.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespFormDtoWithStudyVersion"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-allForms-post",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-allforms-post"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/studyversionobjects/paginated":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects in a paginated format"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getPaginatedStudyVersionObjects_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"offset",
"in":"query",
"description":"Study version index to start from",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Number of study versions to return",
"schema":{
"type":"string",
"default":"1000"
},
"example":1000
},
{
"name":"order",
"in":"query",
"description":"Order in which study versions to be returned",
"schema":{
"type":"string",
"default":"asc"
},
"example":"asc"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-studyversionobjects-paginated-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-studyversionobjects-paginated-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects"
],
"summary":"V6.0",
"description":"Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
}
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/AllStudyVersionsObjectsDtoV9"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/design":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Create study design visits for multiple versions"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Creates list of visits for multiple versions in a study's design.",
"operationId":"getVisitDesign_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"If true, generate light version of the API. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"List of Study Versions. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-design-post",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-design-post"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/studyversionobjects/iprDetails":{
"get":{
"tags":[
"Designer/Study Version APIs/Get IPR details"
],
"summary":"V6.0",
"description":"Retrieves additional investigational product randomization (IPR) details for a study version.",
"operationId":"getAdditionalInfoForIPRs",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used to fetch IPR details. Optional. Allowed values: test, training, active, design.",
"schema":{
"type":"string",
"default":"test"
},
"example":"test"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-studyversionobjects-iprDetails-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-studyversionobjects-iprdetails-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects for a study version"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV6"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV6"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV6"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_22",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, device, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Return the lite visit design response when set to true. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Get visits associated with a form"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves visits associated with a specific form in a study.",
"operationId":"getVisits_7",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"response",
"in":"query",
"description":"Controls response detail level. Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-forms-formid-visits-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Process visits to associate with a specific form"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Processes visits to be associated with a specific form in a study.",
"operationId":"processFormVisits_7",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of visits to associate with a form. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV7"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-forms-formid-visits-post"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_31",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV8"
}
},
"examples":{
"listFormsV7Response":{
"description":"listFormsV7Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV8"
},
"examples":{
"createFormV7Request":{
"description":"createFormV7Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV8"
},
"examples":{
"createFormV7Response":{
"description":"createFormV7Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV8"
},
"examples":{
"getFormV7Response":{
"description":"getFormV7Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV8"
},
"examples":{
"updateFormV7Request":{
"description":"updateFormV7Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV8"
},
"examples":{
"updateFormV7Response":{
"description":"updateFormV7Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV8"
},
"examples":{
"deleteFormV7Response":{
"description":"deleteFormV7Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits_5",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit_5",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV7"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV7"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit_5",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV7"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Updates a kit type in a study.",
"operationId":"updateKit_5",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV7"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV7"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-kits-kitid-put"
},
"delete":{
"tags":[
"Designer/Kits APIs/Delete a kit"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Removes a kit type from a study.",
"operationId":"deleteKit_2",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-kits-{kitId}-delete",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-kits-kitid-delete"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/kits/{kitId}/blindedInfo":{
"get":{
"tags":[
"Designer/Kits APIs/Get blinded data on a kit"
],
"summary":"V7.0",
"description":"Retrieves data on a specific kit in a study.",
"operationId":"getKitBlindedInfo_3",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
},
{
"name":"mode",
"in":"query",
"description":"Study mode used for blinded output filtering. Optional.",
"schema":{
"type":"string",
"default":"test"
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV9"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-kits-{kitId}-blindedInfo-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-kits-kitid-blindedinfo-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/latest/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get latest study version objects"
],
"summary":"V7.0",
"description":"Returns study version objects from the latest study version.",
"operationId":"getStudyVersionObjects_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"modes",
"in":"query",
"description":"Study modes to search for artifacts. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"schema":{
"type":"array",
"items":{
"type":"string",
"enum":[
"design",
"test",
"training",
"active",
"all"
]
}
},
"example":"design"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-latest-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-latest-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/studyDesign":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode.",
"operationId":"getStudyDesignByMode_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"test",
"enum":[
"test",
"active"
]
},
"example":"test"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-studyDesign-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-studydesign-get"
},
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
}
],
"requestBody":{
"description":"Visit details. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV7"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/studyDesign/paginated":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires in a paginated format"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode, in a paginated format.",
"operationId":"getStudyDesignByModePaginated_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"test",
"enum":[
"test",
"active"
]
},
"example":"test"
},
{
"name":"forms",
"in":"query",
"description":"Set to true to paginate forms within each study version node. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"requestBody":{
"description":"Study design pagination Optional.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDesignPaginationDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-studyDesign-paginated-post",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-studydesign-paginated-post"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/studyversionobjects/paginated":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects in a paginated format"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getPaginatedStudyVersionObjects_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"offset",
"in":"query",
"description":"Study version index to start from",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Number of study versions to return",
"schema":{
"type":"string",
"default":"1000"
},
"example":1000
},
{
"name":"order",
"in":"query",
"description":"Order in which study versions to be returned",
"schema":{
"type":"string",
"default":"asc"
},
"example":"asc"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-studyversionobjects-paginated-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-studyversionobjects-paginated-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/statuses/{version}":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get status of latest study version"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves status of a specified study ID and study version.",
"operationId":"getStudy_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"version",
"in":"path",
"description":"Study version. Example: 1.0.0.1",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV7"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-statuses-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-statuses-version-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/statuses":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses of a study"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatuses_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-statuses-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-statuses-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/design":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits for multiple versions"
],
"summary":"V7.0",
"description":"Retrieves the list of visits for multiple versions in a study's design.",
"operationId":"getVisitDesign_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"If true, generate light version of the API. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"List of Study Versions. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-design-post",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-design-post"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects for a study version"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/List visit forms"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves forms associated with a visit for the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms` for the active endpoint.",
"operationId":"getForms_19",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response detail level (`summary` or `details`). Optional.",
"schema":{
"type":"string",
"default":"summary"
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV8"
}
},
"examples":{
"listVisitFormsV7Response":{
"description":"listVisitFormsV7Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV7"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV7"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV7"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_27",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, device, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Return the lite visit design response when set to true. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Get visits associated with a form"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves visits associated with a specific form in a study.",
"operationId":"getVisits_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"response",
"in":"query",
"description":"Controls response detail level. Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-forms-formid-visits-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Process visits to associate with a specific form"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Processes visits to be associated with a specific form in a study.",
"operationId":"processFormVisits_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of visits to associate with a form. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV8"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-forms-formid-visits-post"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_20",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV9"
}
},
"examples":{
"listFormsV8Response":{
"description":"listFormsV8Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV9"
},
"examples":{
"createFormV8Request":{
"description":"createFormV8Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV9"
},
"examples":{
"createFormV8Response":{
"description":"createFormV8Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV9"
},
"examples":{
"getFormV8Response":{
"description":"getFormV8Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV9"
},
"examples":{
"updateFormV8Request":{
"description":"updateFormV8Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV9"
},
"examples":{
"updateFormV8Response":{
"description":"updateFormV8Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV9"
},
"examples":{
"deleteFormV8Response":{
"description":"deleteFormV8Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves list of kits in a study.",
"operationId":"getKits_6",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Creates a new kit type in a study.",
"operationId":"createKit_6",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV8"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV8"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves data on a specific kit in a study.",
"operationId":"getKit_6",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV8"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-kits-kitid-get"
},
"delete":{
"tags":[
"Designer/Kits APIs/Delete a kit"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Removes a kit type from a study.",
"operationId":"deleteKit_3",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-kits-{kitId}-delete",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-kits-kitid-delete"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/studyDesign":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires"
],
"summary":"V8.0",
"description":"Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode.",
"operationId":"getStudyDesignByMode_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"test",
"enum":[
"test",
"active"
]
},
"example":"test"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-studyDesign-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-studydesign-get"
},
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
}
],
"requestBody":{
"description":"Visit details. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV7"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/studyDesign/paginated":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires in a paginated format"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode, in a paginated format.",
"operationId":"getStudyDesignByModePaginated",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"test",
"enum":[
"test",
"active"
]
},
"example":"test"
},
{
"name":"forms",
"in":"query",
"description":"Set to true to paginate forms within each study version node. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"Study design pagination Optional.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDesignPaginationDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-studyDesign-paginated-post",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-studydesign-paginated-post"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/studyversionobjects/paginated":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects in a paginated format"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getPaginatedStudyVersionObjects_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"offset",
"in":"query",
"description":"Study version index to start from",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Number of study versions to return",
"schema":{
"type":"string",
"default":"1000"
},
"example":1000
},
{
"name":"order",
"in":"query",
"description":"Order in which study versions to be returned",
"schema":{
"type":"string",
"default":"asc"
},
"example":"asc"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-studyversionobjects-paginated-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-studyversionobjects-paginated-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/statuses/{version}":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get status of latest study version"
],
"summary":"V8.0",
"description":"Retrieves status of a specified study ID and study version.",
"operationId":"getStudy_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"version",
"in":"path",
"description":"Study version. Example: 1.0.0.1",
"required":true,
"schema":{
"type":"string"
},
"example":"1.0.0.1"
},
{
"name":"firstVisit",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":"",
"enum":[
"ScreeningVisit"
]
},
"example":"ScreeningVisit"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDtoV8"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-statuses-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-statuses-version-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/statuses":{
"get":{
"tags":[
"Designer/Study APIs/Study Actions/Get all statuses of a study"
],
"summary":"V8.0",
"description":"Retrieves all statuses for a specified study ID.",
"operationId":"getStudyStatuses_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"versionStatus",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":""
},
"example":"draft"
},
{
"name":"firstVisit",
"in":"query",
"description":"Study status filter. Allowed values: DRAFT (editable work-in-progress), TESTING (validation phase), APPROVED (production-ready), ARCHIVED (historical copy). Optional.",
"schema":{
"type":"string",
"default":"",
"enum":[
"ScreeningVisit"
]
},
"example":"ScreeningVisit"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"404":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-statuses-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-statuses-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/design":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Create study design visits for multiple versions"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Creates list of visits for multiple versions in a study's design.",
"operationId":"getVisitDesign_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"If true, generate light version of the API. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"List of Study Versions. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-design-post",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-design-post"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects for a study version"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/List visit forms"
],
"summary":"V8.0",
"description":"Retrieves forms associated with a visit for the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms` for the active endpoint.",
"operationId":"getForms_21",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response detail level (`summary` or `details`). Optional.",
"schema":{
"type":"string",
"default":"summary"
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV9"
}
},
"examples":{
"listVisitFormsV8Response":{
"description":"listVisitFormsV8Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of visits in a study.",
"operationId":"queryVisits_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"toTop",
"in":"query",
"description":"Add visit to top in branch schedule Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV8"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV8"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV8"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"[Deprecated]: V8.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_7",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV8"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/visits/{visitid}/dispensings":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get dispensation visits"
],
"summary":"V8.0",
"description":"Retrieves a dispensation visit in a study.",
"operationId":"getDispensings_24",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: standard, titration, device, or all. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ArmKitVisitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visits-{visitid}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visits-visitid-dispensings-get"
}
},
"/ec-designer-svc/rest/v8.0/studies/{studyId}/versions/{version}/visitschedules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule"
],
"summary":"V8.0",
"description":"Retrieves the visit schedule of a study.",
"operationId":"getVisitSchedule_13",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"unscheduledVisits",
"in":"query",
"description":"Whether to include unscheduled visit or not.",
"required":true,
"schema":{
"type":"string",
"default":"include"
},
"example":"include"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v8.0-studies-{studyId}-versions-{version}-visitschedules-get",
"x-filename-id":"ec-designer-svc-rest-v8.0-studies-studyid-versions-version-visitschedules-get"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/design":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Design/Get study design visits"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Retrieves list of visits in a study's design.",
"operationId":"getVisitDesign_14",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"If true, generate light version of the API. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-design-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-design-get"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Get visits associated with a form"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Retrieves visits associated with a specific form in a study.",
"operationId":"getVisits_2",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"response",
"in":"query",
"description":"Response type to query visit forms Optional.",
"schema":{
"type":"string",
"default":"",
"enum":[
"",
"summary",
"summaryLite"
]
},
"example":"summary"
},
{
"name":"mode",
"in":"query",
"description":"Study mode for data classifications. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes).",
"required":true,
"schema":{
"type":"string",
"default":"design",
"enum":[
"test",
"training",
"active",
"design"
]
},
"example":"design"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-formid-visits-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Process visits to associate with a specific form"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Processes visits to be associated with a specific form in a study.",
"operationId":"processFormVisits_2",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of visits to associate with a form. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV9"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-formid-visits-post"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/forms":{
"get":{
"tags":[
"Designer/Form APIs/Forms/List forms"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Retrieves forms in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for the active endpoint.",
"operationId":"getForms_22",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV10"
}
},
"examples":{
"listFormsV9Response":{
"description":"listFormsV9Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-get"
},
"post":{
"tags":[
"Designer/Form APIs/Forms/Create form"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Creates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms` for active create behavior and current metadata mapping.",
"operationId":"addForm_13",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form payload to create. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV10"
},
"examples":{
"createFormV9Request":{
"description":"createFormV9Request",
"value":{
"title":"Demographics",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV10"
},
"examples":{
"createFormV9Response":{
"description":"createFormV9Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-post",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-post"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/forms/{formId}":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get form by ID"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Retrieves one form in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active endpoint.",
"operationId":"getForm_13",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV10"
},
"examples":{
"getFormV9Response":{
"description":"getFormV9Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-{formId}-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-formid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Forms/Update form"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Updates a form in the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for active update behavior.",
"operationId":"updateForm_13",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"Form payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV10"
},
"examples":{
"updateFormV9Request":{
"description":"updateFormV9Request",
"value":{
"title":"Demographics Updated",
"refname":"DM",
"isMainForm":true
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV10"
},
"examples":{
"updateFormV9Response":{
"description":"updateFormV9Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics Updated",
"refname":"DM"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-{formId}-put",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-formid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Forms/Delete form"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Deletes a form from the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/forms/{formId}` for the active delete endpoint.",
"operationId":"deleteForm_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormDtoV10"
},
"examples":{
"deleteFormV9Response":{
"description":"deleteFormV9Response",
"value":{
"result":"Form deleted successfully"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/forms/randomizationfactors":{
"get":{
"tags":[
"Designer/Form APIs/Forms/Get list questions used in stratified randomization"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Retrieves all questions used in stratified randomization designs in a specific study version.",
"operationId":"getStratificationFactors_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov10"
}
},
"examples":{
"listStratificationFactorsV9Response":{
"description":"listStratificationFactorsV9Response",
"value":{
"result":[
{
"id":"4A5C8D0E2F1B4D56A23C9F3A0C7D4E99",
"name":"Age Group",
"itemType":"NUMBER"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-forms-randomizationfactors-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-forms-randomizationfactors-get"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/kits":{
"get":{
"tags":[
"Designer/Kits APIs/Get list of all kits"
],
"summary":"V9.0",
"description":"Retrieves list of kits in a study.",
"operationId":"getKits_7",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-kits-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-kits-get"
},
"post":{
"tags":[
"Designer/Kits APIs/Add a kit in a study"
],
"summary":"V9.0",
"description":"Creates a new kit type in a study.",
"operationId":"createKit_7",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Kit payload used to create a kit record. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV9"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV9"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-kits-post",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-kits-post"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/kits/{kitId}":{
"get":{
"tags":[
"Designer/Kits APIs/Get data on a kit"
],
"summary":"V9.0",
"description":"Retrieves data on a specific kit in a study.",
"operationId":"getKit_7",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV9"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-kits-{kitId}-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-kits-kitid-get"
},
"put":{
"tags":[
"Designer/Kits APIs/Update a kit"
],
"summary":"V9.0",
"description":"Updates a kit type in a study.",
"operationId":"updateKit_6",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Kit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV9"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/KitDtoV9"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-kits-{kitId}-put",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-kits-kitid-put"
},
"delete":{
"tags":[
"Designer/Kits APIs/Delete a kit"
],
"summary":"V9.0",
"description":"Removes a kit type from a study.",
"operationId":"deleteKit_4",
"parameters":[
{
"name":"kitType",
"in":"query",
"description":"Kit type filter. Optional. Accepted values include STANDARD, TITRATION, ALL, and DEVICE.",
"schema":{
"type":"string"
},
"example":"ALL"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"kitId",
"in":"path",
"description":"Kit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"string"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-kits-{kitId}-delete",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-kits-kitid-delete"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/studyDesign":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Create all visits, forms and questionnaires"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Creates all the visits, forms and questionnaires for the study ID on one or more study versions.",
"operationId":"getStudyDesign_6",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"Request the lite version of the response that does not include all form item details. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":true
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"Visit details. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVersionVisitDtoV9"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-studyDesign-post",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-studydesign-post"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/studyDesign/paginated":{
"post":{
"tags":[
"Designer/Study APIs/Study Actions/Get all visits, forms and questionnaires in a paginated format"
],
"summary":"V9.0",
"description":"Retrieves all the visits, forms and questionnaires in a study ID in one or more study versions and by mode, in a paginated format.",
"operationId":"getStudyDesignByModePaginated_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"mode",
"in":"query",
"description":"Study mode filter. Allowed values: design (draft design data), test (testing data), training (training data), active (approved production data), all (all modes). Optional.",
"schema":{
"type":"string",
"default":"test",
"enum":[
"test",
"active"
]
},
"example":"test"
},
{
"name":"forms",
"in":"query",
"description":"Set to true to paginate forms within each study version node. Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"dynamicData",
"in":"query",
"description":"Return details when call made by service to service Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"Study design pagination Optional.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/StudyDesignPaginationDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"name":"Hypertension Study",
"version":"1.0.0.1"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-studyDesign-paginated-post",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-studydesign-paginated-post"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/studyversionobjects/paginated":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects in a paginated format"
],
"summary":"V9.0",
"description":"Retrieves all study version objects.",
"operationId":"getPaginatedStudyVersionObjects_4",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required. Example: F054C951EB74443C93716CA714AB686E",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"offset",
"in":"query",
"description":"Study version index to start from",
"schema":{
"type":"string",
"default":"0"
},
"example":0
},
{
"name":"limit",
"in":"query",
"description":"Number of study versions to return",
"schema":{
"type":"string",
"default":"1000"
},
"example":1000
},
{
"name":"order",
"in":"query",
"description":"Order in which study versions to be returned",
"schema":{
"type":"string",
"default":"asc"
},
"example":"asc"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category. Optional.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-studyversionobjects-paginated-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-studyversionobjects-paginated-get"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/design":{
"post":{
"tags":[
"Designer/Visit APIs/Visit Design/Create study design visits for multiple versions"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Creates list of visits for multiple versions in a study's design.",
"operationId":"getVisitDesign_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"isLiteAPI",
"in":"query",
"description":"If true, generate light version of the API. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"List of Study Versions. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitBranchDesignDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-design-post",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-design-post"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/studyversionobjects":{
"get":{
"tags":[
"Designer/Study Version APIs/Get study version objects for a study version"
],
"summary":"V9.0",
"description":"Retrieves all study version objects.",
"operationId":"getStudyVersionObjects_9",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"formCategory",
"in":"query",
"description":"Return forms with this Form Category.",
"schema":{
"type":"string",
"default":"DCS"
},
"example":"DCS"
}
],
"responses":{
"default":{
"description":"default response",
"content":{
"application/json":{
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-studyversionobjects-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-studyversionobjects-get"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a visit"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms added to a specific visit in a study.",
"operationId":"getForms_23",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response detail level (`summary` or `details`). Optional.",
"schema":{
"type":"string",
"default":"summary"
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV10"
}
},
"examples":{
"listVisitFormsV9Response":{
"description":"listVisitFormsV9Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/visits":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get list of visits for a study version"
],
"summary":"V9.0",
"description":"Retrieves a list of visits in a study.",
"operationId":"queryVisits_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"blindingBranchLabel",
"in":"query",
"description":"Blind visit branch labels Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
},
{
"name":"sort",
"in":"query",
"description":"Get visits sorted Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-visits-get"
},
"post":{
"tags":[
"Designer/Visit APIs/Visits/Add a visit"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Adds a visit in your study.",
"operationId":"addVisit_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"toTop",
"in":"query",
"description":"Add visit to top in branch schedule Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
},
{
"name":"copyScreeningVisit",
"in":"query",
"description":"Copy the screening event to make an identical re-screen event Optional.",
"schema":{
"type":"boolean",
"default":false
},
"example":false
}
],
"requestBody":{
"description":"Visit payload used to create a visit. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV9"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-visits-post"
}
},
"/ec-designer-svc/rest/v9.0/studies/{studyId}/versions/{version}/visits/{visitid}":{
"get":{
"tags":[
"Designer/Visit APIs/Visits/Get study visit"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Retrieves a visit in a study.",
"operationId":"getVisit_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV9"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-visits-{visitid}-get",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-visits-visitid-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visits/Update a visit"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Updates a visit in your study.",
"operationId":"updateVisit_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Visit payload with updated values. Required.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/VisitDtoV9"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-visits-{visitid}-put",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-visits-visitid-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visits/Delete a visit"
],
"summary":"[Deprecated]: V9.0",
"description":"Deprecated: Use latest version instead. Removes a visit from your study.",
"operationId":"deleteVisit_8",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitDtoV9"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening",
"visitType":"scheduled",
"order":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v9.0-studies-{studyId}-versions-{version}-visits-{visitid}-delete",
"x-filename-id":"ec-designer-svc-rest-v9.0-studies-studyid-versions-version-visits-visitid-delete"
}
},
"/ec-designer-svc/rest/locks/acquireLock/{studyId}":{
"post":{
"tags":[
"Designer/Study APIs/Study Lock"
],
"summary":"Acquire lock",
"description":"Acquires the lock of a study or study object.",
"operationId":"acquireLock",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"requestBody":{
"description":"The lock to acquire.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/DesignerLockDetailsDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResponseTo"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-locks-acquireLock-{studyId}-post",
"x-filename-id":"ec-designer-svc-rest-locks-acquirelock-studyid-post"
}
},
"/ec-designer-svc/rest/locks/childLocks/{studyId}":{
"get":{
"tags":[
"Designer/Study APIs/Study Lock"
],
"summary":"Get all the active locks on the study",
"description":"Acquires the lock of a study or study object.",
"operationId":"getAllChildLocks",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"lockBasePath",
"in":"query",
"description":"Base path used to filter lock nodes. Optional.",
"schema":{
"type":"string"
},
"example":"/locks/studies"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ChildLockData"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-locks-childLocks-{studyId}-get",
"x-filename-id":"ec-designer-svc-rest-locks-childlocks-studyid-get"
}
},
"/ec-designer-svc/rest/locks/releaseLock/{studyId}":{
"put":{
"tags":[
"Designer/Study APIs/Study Lock"
],
"summary":"Release lock",
"description":"Release the all study locks held by the logged in user.",
"operationId":"releaseLock",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ResponseTo"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-locks-releaseLock-{studyId}-put",
"x-filename-id":"ec-designer-svc-rest-locks-releaselock-studyid-put"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/forms/{formId}/itemhistory":{
"get":{
"tags":[
"Designer/Form APIs/Form Item History/Get questions history for a form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves history of questions associated with a specific form.",
"operationId":"getItemHistory",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormHistoryDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-forms-{formId}-itemhistory-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-forms-formid-itemhistory-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/{formId}/items":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get questions for a form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves questions associated with a specific form.",
"operationId":"getItems",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-items-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-items-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form Item/Add a question in a form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Adds a question to a specific form in a study.",
"operationId":"addItem",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form item payload used to create a new form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-items-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-items-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/{formId}/items/{itemId}":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get a question for a form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a specific question associated with a form.",
"operationId":"getItem",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-items-itemid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Form Item/Update a question in a form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates a question included in a form in a study.",
"operationId":"updateItem",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"requestBody":{
"description":"Form item payload used to update an existing form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-items-itemid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Form Item/Delete a question from a form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a question from a specific form in a study.",
"operationId":"deleteItem",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"object"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-items-itemid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/List visits for a form"
],
"summary":"V1.0",
"description":"Retrieves visits associated with a form in a study version. Use the latest supported version of this endpoint in v17.0 for current behavior.",
"operationId":"getVisits_4",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV1"
}
},
"examples":{
"listFormVisitsV1Response":{
"description":"listFormVisitsV1Response",
"value":{
"result":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"name":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-visits-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Update form visit assignments"
],
"summary":"V1.0",
"description":"Updates visit assignments for a form. Use the latest supported version of this endpoint in v17.0 for current behavior.",
"operationId":"processFormVisits_4",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"List of visits to associate with the form. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV1"
}
},
"examples":{
"updateFormVisitsV1Request":{
"description":"updateFormVisitsV1Request",
"value":[
{
"id":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"updateFormVisitsV1Response":{
"description":"updateFormVisitsV1Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-forms-formid-visits-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/lockObjectDetails":{
"post":{
"tags":[
"Designer/Lock Object APIs/Create list of locked objects"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Creates a list of locked objects as on locked date.",
"operationId":"queryLockObjects",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode to filter locked objects.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
}
],
"requestBody":{
"description":"List of locked objects as on locked date.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/LockVersionObjectDtoV1"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LockObjectDetailsDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-lockObjectDetails-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-lockobjectdetails-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/cohorts/{cohortId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Get cohort group in a randomization"
],
"summary":"V1.0",
"description":"Retrieves a specific cohort group associated with a randomization design.",
"operationId":"getCohort",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"cohortId",
"in":"path",
"description":"Cohort identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6B3C2D1E8F4A4D56A23C9F3A0C7D4E33"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CohortDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-{cohortId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-cohorts-cohortid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Update existing cohort group"
],
"summary":"V1.0",
"description":"Updates a cohort group associated with a randomization.",
"operationId":"updateCohort",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"cohortId",
"in":"path",
"description":"Cohort identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6B3C2D1E8F4A4D56A23C9F3A0C7D4E33"
}
],
"requestBody":{
"description":"Cohort payload with updated values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CohortDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CohortDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-{cohortId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-cohorts-cohortid-put"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Delete cohort group"
],
"summary":"V1.0",
"description":"Removes a a cohort group from a randomization design.",
"operationId":"deleteCohort",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"cohortId",
"in":"path",
"description":"Cohort identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6B3C2D1E8F4A4D56A23C9F3A0C7D4E33"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
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"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-{cohortId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-cohorts-cohortid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/cohorts/bulk":{
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Update multiple existing cohort groups"
],
"summary":"V1.0",
"description":"Updates a list of cohort groups associated with a randomization design.",
"operationId":"updateCohorts",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of cohort payloads with updated values for bulk update.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RqstCohortDto"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortDtoV1"
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},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-bulk-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-cohorts-bulk-put"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Create multiple cohort groups"
],
"summary":"V1.0",
"description":"Creates a list of new cohort groups associated with a randomization design.",
"operationId":"saveCohorts",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
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{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of cohort payloads used to create cohorts in bulk.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortDtoV1"
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},
"examples":{
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"description":"requestExample",
"value":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
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"items":{
"$ref":"#/components/schemas/CohortDtoV1"
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},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-bulk-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-cohorts-bulk-post"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Delete multiple existing cohort groups"
],
"summary":"V1.0",
"description":"Removes a list of cohort groups associated with a randomization design.",
"operationId":"deleteCohorts",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
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{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of cohort payloads used to delete cohorts in bulk.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortDtoV1"
}
},
"examples":{
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"description":"requestExample",
"value":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortDtoV1"
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},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
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}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-bulk-delete",
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},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/cohorts":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Get a list of all cohort groups in a randomization"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of all cohort groups associated with a randomization design.",
"operationId":"getCohortList",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
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"items":{
"$ref":"#/components/schemas/CohortDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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}
}
}
},
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"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-cohorts-get"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Create a single cohort group"
],
"summary":"V1.0",
"description":"Creates a new cohort group in a randomization design.",
"operationId":"saveCohort",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Cohort payload used to create a cohort.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CohortDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CohortDtoV1"
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-cohorts-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get all treatment arm ratios for cohort or stratum groups by randomization ID"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of treatment arm ratios associated with all cohort or stratum groups in a randomization design, filtred by randomization ID.",
"operationId":"getRatiosList",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
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}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
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"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
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},
"examples":{
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"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
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"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
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]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Update treatment arm ratios for adaptive cohorts"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates treatment arm ratios associated with adaptive cohorts in a randomization design.",
"operationId":"storeRatios",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of treatment-arm ratio payloads with updated values.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
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"description":"requestExample",
"value":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
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}
]
}
}
}
},
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},
"responses":{
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"description":"Successful operation.",
"content":{
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"schema":{
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"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
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}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
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"schema":{
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"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
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"description":"successResponse",
"value":{
"result":[
{
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]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
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}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-put"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Create treatment arms ratios"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Creates treatment arm rations in a randomization design.",
"operationId":"postRatios",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization treatment-arm ratio payload used to create ratios.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-post"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Delete all treatment arm ratios"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Use PUT instead. Delete all treatment arm ratios in a randomization design.",
"operationId":"deleteAllRatios",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios/{groupingsId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get treatment arm ratios for cohort or stratum groups"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves treatment arm ratios associated with a cohort or stratum group in a randomization design.",
"operationId":"getRatios",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"groupingsId",
"in":"path",
"description":"Randomization cohort/stratum grouping identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-{groupingsId}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-groupingsid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Update treatment arm ratios"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates treatment arm ratios in a randomization design.",
"operationId":"putRatios",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"groupingsId",
"in":"path",
"description":"Randomization cohort/stratum grouping identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Randomization treatment-arm ratio payload with updated values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-{groupingsId}-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-groupingsid-put"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Delete treatment arm ratios"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Use PUT instead. Removes treatment arm ratios in a randomization.",
"operationId":"deleteRatios",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"groupingsId",
"in":"path",
"description":"Randomization cohort/stratum grouping identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV1"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-{groupingsId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-groupingsid-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios/arms":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get list of treatment arms"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves list of treatment arms associated with a randomization design.",
"operationId":"getArms",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitDesignPathIds",
"in":"query",
"description":"Comma-separated list of Visit Design Path IDs (UUIDs) to scope the randomization retrieval and this parameter is applicable for algorithm type None only Optional.",
"schema":{
"type":"string"
},
"example":"3BCE1EE7AD7B4625B76876A49A7144CF,4BCE1EE7AD7B4625B76876A49A7144CE,7BCE1EE7AD7B4625B76876A49A7144CD"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioArmDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioArmDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-arms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-arms-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios/adaptivecohort":{
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Update treatment arm ratios for adaptive cohorts"
],
"summary":"V1.0",
"description":"Updates treatment arm ratios associated with adaptive cohorts in a randomization design.",
"operationId":"putAdaptiveCohortRatios",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"groupingsId",
"in":"query",
"description":"Randomization cohort/stratum grouping identifier (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Array of adaptive cohort ratio payloads with updated values.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RqstCohortGroupingDtoV1"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RqstCohortGroupingDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RqstCohortGroupingDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-adaptivecohort-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-ratios-adaptivecohort-put"
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},
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"get":{
"tags":[
"Designer/Randomization APIs/Study Strata/Get a stratum group"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a stratum group associated with a randomization design.",
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{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"format":"uuid"
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"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
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{
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"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"example":"1.0.0.1"
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"examples":{
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"description":"successResponse",
"value":{
"result":{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
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}
}
}
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{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"format":"uuid"
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{
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"type":"string",
"example":"1.0.0.1"
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{
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"in":"path",
"description":"Stratum identifier (UUID, 32-character uppercase hexadecimal string). Required.",
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"format":"uuid"
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"example":"5C2D1E8F4A6B4D56A23C9F3A0C7D4E44"
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"requestBody":{
"description":"Stratum payload with updated values.",
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"application/json":{
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"$ref":"#/components/schemas/StratumDtoV1"
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"examples":{
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"description":"requestExample",
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"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
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}
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"tags":[
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes a stratum group associated with a randomization design.",
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{
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"example":"F054C951EB74443C93716CA714AB686E"
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"type":"string",
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{
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"in":"path",
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"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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"description":"Deprecated: Use latest version instead. Updates a list of cohort groups associated with a randomization design.",
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{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
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"format":"uuid"
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"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
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"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"type":"string",
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"example":"1.0.0.1"
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"requestBody":{
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{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
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}
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"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
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"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
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}
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"description":"Deprecated: Use latest version instead. Creates a list of new cohort groups associated with a randomization design.",
"operationId":"saveStratums_2",
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"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
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"type":"string",
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"requestBody":{
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"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
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"content":{
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}
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"description":"Deprecated: Use latest version instead. Removes a list of cohort groups associated with a randomization design.",
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"parameters":[
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"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"format":"uuid"
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"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
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{
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"type":"string",
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},
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of all strata groups associated with a randomization design.",
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"in":"path",
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"type":"string",
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"example":"F054C951EB74443C93716CA714AB686E"
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"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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"content":{
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"value":{
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{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
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}
}
}
}
}
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"content":{
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"post":{
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"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Creates a new stratum group associated with a randomization design.",
"operationId":"saveStratums_3",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
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"schema":{
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"type":"string",
"format":"uuid"
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"example":"F054C951EB74443C93716CA714AB686E"
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"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
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"example":"1.0.0.1"
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"requestBody":{
"description":"Stratum payload used to create a stratum.",
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"schema":{
"$ref":"#/components/schemas/StratumDtoV1"
},
"examples":{
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"value":{
"id":"4BCE1EE7AD7B4625B76876A49A7144CE",
"name":"Age 18-65"
}
}
}
}
},
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},
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"description":"Successful operation.",
"content":{
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"schema":{
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"description":"successResponse",
"value":{
"result":{
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"name":"Age 18-65"
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}
}
}
}
}
},
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"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
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"schema":{
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}
}
}
}
},
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"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-strata-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-randomizations-randomid-strata-post"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a study"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms in a study for a specific study version.",
"operationId":"getForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
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"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
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"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"responses":{
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"description":"Successful operation.",
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"items":{
"$ref":"#/components/schemas/VisitFormDtoV1"
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},
"examples":{
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"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
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]
}
}
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}
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"content":{
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}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-forms-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visit Forms/Update forms of a specific visit"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Updates forms associated with a specific visit in a study.",
"operationId":"updateForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of form IDs to associate with the visit. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"replaceVisitFormsV1Request":{
"description":"replaceVisitFormsV1Request",
"value":[
"B1B8327AFAA6412287106192AB5984EF",
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV1"
}
},
"examples":{
"replaceVisitFormsV1Response":{
"description":"replaceVisitFormsV1Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-forms-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Delete specific or all forms from a visit"
],
"summary":"V1.0",
"description":"Removes specified or all forms from a specific visit in a study.",
"operationId":"removeForms",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Form IDs to remove from the visit. Omit or pass null to remove all forms.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-forms-delete"
}
},
"/ec-designer-svc/rest/v1.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms/{formId}":{
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Remove visit form"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Removes one form from a visit in a study version. Use the latest supported visit-form endpoint in v17.0 for current behavior.",
"operationId":"removeForm",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV1"
}
},
"examples":{
"removeVisitFormV1Response":{
"description":"removeVisitFormV1Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-studyid-versions-version-visits-visitid-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v1.0/visitschedules/{studyId}/{version}":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule of a study version"
],
"summary":"[Deprecated]: V1.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule in a study for a study version.",
"operationId":"getVisitSchedule_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v1.0-visitschedules-{studyId}-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-visitschedules-studyid-version-get"
}
},
"/ec-designer-svc/rest/v1.0/studies/welcome":{
"get":{
"tags":[
"Designer/Welcome APIs/Get welcome message"
],
"summary":"V1.0",
"description":"Retrieves a welcome message.",
"operationId":"getWelcome",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"query",
"description":"Study identifier (UUID, 32-character uppercase hexadecimal string). Optional. When omitted, tenant-level welcome text is used.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"00000000000000000000000000000000"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/WelcomeDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"message":"Welcome to Clinical One Design",
"tenant":"DESIGN"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-welcome-get",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-welcome-get"
},
"put":{
"tags":[
"Designer/Welcome APIs/Update welcome message"
],
"summary":"V1.0",
"description":"Updates a welcome message.",
"operationId":"updateWelcome",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"query",
"description":"Study identifier (UUID, 32-character uppercase hexadecimal string). Optional. When omitted, tenant-level welcome text is used.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"00000000000000000000000000000000"
}
],
"requestBody":{
"description":"Welcome message payload used to update an existing welcome configuration.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RqstWelcomeDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"message":"Welcome to Clinical One Design",
"tenant":"DESIGN"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/WelcomeDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"message":"Welcome to Clinical One Design",
"tenant":"DESIGN"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-welcome-put",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-welcome-put"
},
"post":{
"tags":[
"Designer/Welcome APIs/Create welcome message"
],
"summary":"V1.0",
"description":"Creates a welcome message.",
"operationId":"createWelcome",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"query",
"description":"Study identifier (UUID, 32-character uppercase hexadecimal string). Optional. When omitted, tenant-level welcome text is used.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"00000000000000000000000000000000"
}
],
"requestBody":{
"description":"Welcome message payload used to create a welcome configuration.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RqstWelcomeDto"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"message":"Welcome to Clinical One Design",
"tenant":"DESIGN"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/WelcomeDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"message":"Welcome to Clinical One Design",
"tenant":"DESIGN"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-welcome-post",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-welcome-post"
},
"delete":{
"tags":[
"Designer/Welcome APIs/Delete welcome message"
],
"summary":"V1.0",
"description":"Deletes a welcome message.",
"operationId":"deleteWelcome",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"studyId",
"in":"query",
"description":"Study identifier (UUID, 32-character uppercase hexadecimal string). Optional. When omitted, tenant-level welcome text is used.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"00000000000000000000000000000000"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/WelcomeDto"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"message":"Welcome to Clinical One Design",
"tenant":"DESIGN"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v1.0-studies-welcome-delete",
"x-filename-id":"ec-designer-svc-rest-v1.0-studies-welcome-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/forms/{formId}/itemhistory":{
"get":{
"tags":[
"Designer/Form APIs/Form Item History/Get questions history for a form"
],
"summary":"V2.0",
"description":"Retrieves history of questions associated with a specific form.",
"operationId":"getItemHistory_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormHistoryDto"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-forms-{formId}-itemhistory-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-forms-formid-itemhistory-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms/{formId}/items":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get questions for a form"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves questions associated with a specific form.",
"operationId":"getItems_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-items-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-items-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form Item/Add a question in a form"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Adds a question to a specific form in a study.",
"operationId":"addItem_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form item payload used to create a new form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-items-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-items-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/forms/{formId}/items/{itemId}":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get a question for a form"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a specific question associated with a form.",
"operationId":"getItem_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-items-itemid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Form Item/Update a question in a form"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Updates a question included in a form in a study.",
"operationId":"updateItem_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"requestBody":{
"description":"Form item payload used to update an existing form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-items-itemid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Form Item/Delete a question from a form"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Removes a question from a specific form in a study.",
"operationId":"deleteItem_1",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-forms-formid-items-itemid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/lockObjectDetails":{
"post":{
"tags":[
"Designer/Lock Object APIs/Get locked objects"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of locked objects as on locked date.",
"operationId":"queryLockObjects_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode to filter locked objects.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"showVisitDetails",
"in":"query",
"description":"Include visit-level lock details in the response. Optional.",
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"itemsIncluded",
"in":"query",
"description":"Include item details in the response payload. Optional.",
"schema":{
"type":"boolean"
},
"example":true
}
],
"requestBody":{
"description":"List of locked objects as on locked date.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/LockObjectDtoV2"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LockObjectDetailsDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-lockObjectDetails-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-lockobjectdetails-post"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/cohorts":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Cohorts/Get a list of all cohort groups in a randomization"
],
"summary":"V2.0",
"description":"Retrieves a list of all cohort groups associated with a randomization design.",
"operationId":"getCohortList_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CohortDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"3BCE1EE7AD7B4625B76876A49A7144CF",
"name":"Cohort A",
"number":1
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-cohorts-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-cohorts-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get all treatment arm ratios for cohort or stratum groups by randomization ID"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves a list of treatment arm ratios associated with all cohort or stratum groups in a randomization design, filtred by randomization ID.",
"operationId":"getRatiosList_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Update treatment arm ratios for adaptive cohorts"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Updates treatment arm ratios associated with adaptive cohorts in a randomization design.",
"operationId":"storeRatios_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of treatment-arm ratio payloads with updated values.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-put"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Create treatment arms ratios"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Creates treatment arm rations in a randomization design.",
"operationId":"postRatios_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization treatment-arm ratio payload used to create ratios.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-post",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-post"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Delete all treatment arm ratios"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Use PUT instead. Delete all treatment arm ratios in a randomization design.",
"operationId":"deleteAllRatios_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios/{groupingsId}":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get treatment arm ratios for cohort or stratum groups"
],
"summary":"V2.0",
"description":"Retrieves treatment arm ratios associated with a cohort or stratum group in a randomization design.",
"operationId":"getRatios_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"groupingsId",
"in":"path",
"description":"Randomization cohort/stratum grouping identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-{groupingsId}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-groupingsid-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Update treatment arm ratios"
],
"summary":"V2.0",
"description":"Updates treatment arm ratios in a randomization design.",
"operationId":"putRatios_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"groupingsId",
"in":"path",
"description":"Randomization cohort/stratum grouping identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"requestBody":{
"description":"Randomization treatment-arm ratio payload with updated values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-{groupingsId}-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-groupingsid-put"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Delete treatment arm ratios"
],
"summary":"V2.0",
"description":"Use PUT instead. Removes treatment arm ratios in a randomization.",
"operationId":"deleteRatios_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"groupingsId",
"in":"path",
"description":"Randomization cohort/stratum grouping identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV2"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-{groupingsId}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-groupingsid-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios/arms":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get list of treatment arms"
],
"summary":"V2.0",
"description":"Retrieves list of treatment arms associated with a randomization design.",
"operationId":"getArms_1",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitDesignPathIds",
"in":"query",
"description":"Comma-separated list of Visit Design Path IDs (UUIDs) to scope the randomization retrieval and this parameter is applicable for algorithm type None only Optional.",
"schema":{
"type":"string"
},
"example":"3BCE1EE7AD7B4625B76876A49A7144CF,4BCE1EE7AD7B4625B76876A49A7144CE,7BCE1EE7AD7B4625B76876A49A7144CD"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioArmDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioArmDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"8E1A7B6C2D3F4A55B12C9D4E6F708192",
"name":"Primary Randomization",
"method":"block"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-arms-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-randomizations-randomid-ratios-arms-get"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/List visit forms"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Retrieves forms associated with a visit in a study version. Use `/v17.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms` for the active endpoint.",
"operationId":"getForms_15",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response level. Optional. Allowed values: `summary` (default), `details`.",
"schema":{
"type":"string",
"example":"summary",
"default":"summary"
}
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV2"
}
},
"examples":{
"listVisitFormsV2Response":{
"description":"listVisitFormsV2Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-forms-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visit Forms/Replace visit forms"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Replaces form assignments on a visit for a study version. Use the latest supported visit-form endpoint in v17.0 for current behavior.",
"operationId":"updateForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of form IDs to associate with the visit. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"replaceVisitFormsV2Request":{
"description":"replaceVisitFormsV2Request",
"value":[
"B1B8327AFAA6412287106192AB5984EF",
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV1"
}
},
"examples":{
"replaceVisitFormsV2Response":{
"description":"replaceVisitFormsV2Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-put",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-forms-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Remove multiple visit forms"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Removes selected forms from a visit or removes all forms when payload is omitted.",
"operationId":"removeForms_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Form IDs to remove from the visit. Omit or pass null to remove all forms.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV1"
}
},
"examples":{
"removeVisitFormsV2Response":{
"description":"removeVisitFormsV2Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-forms-delete"
}
},
"/ec-designer-svc/rest/v2.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms/{formId}":{
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Remove visit form"
],
"summary":"[Deprecated]: V2.0",
"description":"Deprecated: Use latest version instead. Removes one form from a visit in a study version. Use the latest supported visit-form endpoint in v17.0 for current behavior.",
"operationId":"removeForm_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV1"
}
},
"examples":{
"removeVisitFormV2Response":{
"description":"removeVisitFormV2Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v2.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v2.0-studies-studyid-versions-version-visits-visitid-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v2.0/visitschedules/{studyId}/{version}":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule of a study version"
],
"summary":"V2.0",
"description":"Retrieves the visit schedule in a study for a study version.",
"operationId":"getVisitSchedule_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v2.0-visitschedules-{studyId}-{version}-get",
"x-filename-id":"ec-designer-svc-rest-v2.0-visitschedules-studyid-version-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/forms/{formId}/items":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get questions for a form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves questions associated with a specific form.",
"operationId":"getItems_2",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-items-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-items-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form Item/Add a question in a form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Adds a question to a specific form in a study.",
"operationId":"addItem_2",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form item payload used to create a new form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-items-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-items-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/forms/{formId}/items/{itemId}":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get a question for a form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves a specific question associated with a form.",
"operationId":"getItem_2",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-items-itemid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Form Item/Update a question in a form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Updates a question included in a form in a study.",
"operationId":"updateItem_2",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"requestBody":{
"description":"Form item payload used to update an existing form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-items-itemid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Form Item/Delete a question from a form"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Removes a question from a specific form in a study.",
"operationId":"deleteItem_2",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"object"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Design Item"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-forms-formid-items-itemid-delete"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/lockObjectDetails":{
"post":{
"tags":[
"Designer/Lock Object APIs/Get locked objects"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Retrieves a list of locked objects as on locked date.",
"operationId":"queryLockObjects_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"mode",
"in":"query",
"description":"Study mode to filter locked objects.",
"required":true,
"schema":{
"type":"string",
"enum":[
"test",
"training",
"active"
]
},
"example":"test"
},
{
"name":"showVisitDetails",
"in":"query",
"description":"Include visit-level lock details in the response. Optional.",
"schema":{
"type":"boolean"
},
"example":false
},
{
"name":"itemsIncluded",
"in":"query",
"description":"Include item details in the response payload. Optional.",
"schema":{
"type":"boolean"
},
"example":true
},
{
"name":"excludeItemType",
"in":"query",
"description":"Form Item type to exclude from response Optional.",
"schema":{
"type":"string",
"enum":[
"instructionalText"
]
},
"example":"instructionalText"
},
{
"name":"dynamicData",
"in":"query",
"description":"Return dynamic data in lock details. Optional.",
"schema":{
"type":"boolean",
"default":true
},
"example":true
}
],
"requestBody":{
"description":"List of locked objects as on locked date.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/LockObjectDtoV3"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/LockObjectDetailsDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"F054C951EB74443C93716CA714AB686E",
"lockedBy":"designer.user",
"lockedOn":"2026-04-17T10:00:00Z"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-lockObjectDetails-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-lockobjectdetails-post"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/randomizations/{randomId}/ratios":{
"get":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Get all treatment arm ratios for cohort or stratum groups by randomization ID"
],
"summary":"V3.0",
"description":"Retrieves a list of treatment arm ratios associated with all cohort or stratum groups in a randomization design, filtred by randomization ID.",
"operationId":"getRatiosList_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-ratios-get"
},
"put":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Update treatment arm ratios for adaptive cohorts"
],
"summary":"V3.0",
"description":"Updates treatment arm ratios associated with adaptive cohorts in a randomization design.",
"operationId":"storeRatios_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of treatment-arm ratio payloads with updated values.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-ratios-put"
},
"post":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Create treatment arms ratios"
],
"summary":"V3.0",
"description":"Creates treatment arm rations in a randomization design.",
"operationId":"postRatios_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Randomization treatment-arm ratio payload used to create ratios.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-post",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-ratios-post"
},
"delete":{
"tags":[
"Designer/Randomization APIs/Randomization Ratios/Delete all treatment arm ratios"
],
"summary":"V3.0",
"description":"Use PUT instead. Delete all treatment arm ratios in a randomization design.",
"operationId":"deleteAllRatios_2",
"parameters":[
{
"name":"randomId",
"in":"path",
"description":"Randomization identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"8E1A7B6C2D3F4A55B12C9D4E6F708192"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"204":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RatioGroupingDtoV3"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"groupingId":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"arms":[
{
"armId":"3BCE1EE7AD7B4625B76876A49A7144CF",
"ratio":1
}
]
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-randomizations-{randomId}-ratios-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-randomizations-randomid-ratios-delete"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/List visit forms"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Retrieves forms associated with a visit for the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms` for the active endpoint.",
"operationId":"getForms_16",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response detail level (`summary` or `details`). Optional.",
"schema":{
"type":"string",
"default":"summary"
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV3"
}
},
"examples":{
"listVisitFormsV3Response":{
"description":"listVisitFormsV3Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-forms-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visit Forms/Update forms of a specific visit"
],
"summary":"V3.0",
"description":"Updates forms associated with a specific visit in a study.",
"operationId":"updateForms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of form IDs to associate with the visit. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"replaceVisitFormsV3Request":{
"description":"replaceVisitFormsV3Request",
"value":[
"B1B8327AFAA6412287106192AB5984EF",
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV3"
}
},
"examples":{
"replaceVisitFormsV3Response":{
"description":"replaceVisitFormsV3Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-put",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-forms-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Remove multiple visit forms"
],
"summary":"[Deprecated]: V3.0",
"description":"Deprecated: Use latest version instead. Removes selected forms from a visit or removes all forms when payload is omitted.",
"operationId":"removeForms_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Form IDs to remove from the visit. Omit or pass null to remove all forms.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV3"
}
},
"examples":{
"removeVisitFormsV3Response":{
"description":"removeVisitFormsV3Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-forms-delete"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms/rules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get visit form rules"
],
"summary":"V3.0",
"description":"Retrieves item rules for forms on a visit. Use the latest supported version of this endpoint in v17.0 for current behavior and metadata.",
"operationId":"getItemRules",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"property",
"in":"query",
"description":"Rule lookup property (`item` or `visitStartDate`). Optional.",
"schema":{
"type":"string",
"default":"item"
},
"example":"item"
},
{
"name":"formId",
"in":"query",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"itemId",
"in":"query",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Optional.",
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemRuleDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-rules-get",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-forms-rules-get"
}
},
"/ec-designer-svc/rest/v3.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms/{formId}":{
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Delete form from a specific visit"
],
"summary":"V3.0",
"description":"Removes form from a specific visit in a study.",
"operationId":"removeForm_2",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV3"
}
},
"examples":{
"removeVisitFormV3Response":{
"description":"removeVisitFormV3Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v3.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v3.0-studies-studyid-versions-version-visits-visitid-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/forms/{formId}/items":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get questions for a form"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves questions associated with a specific form.",
"operationId":"getItems_3",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV4"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-items-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-items-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form Item/Add a question in a form"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Adds a question to a specific form in a study.",
"operationId":"addItem_3",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form item payload used to create a new form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-items-post",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-items-post"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/forms/{formId}/items/{itemId}":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get a question for a form"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves a specific question associated with a form.",
"operationId":"getItem_3",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-items-itemid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Form Item/Update a question in a form"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Updates a question included in a form in a study.",
"operationId":"updateItem_3",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"requestBody":{
"description":"Form item payload with updated values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV4"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV4"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-items-itemid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Form Item/Delete a question from a form"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Removes a question from a specific form in a study.",
"operationId":"deleteItem_3",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-delete",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-forms-formid-items-itemid-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/List visit forms"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves forms associated with a visit for the requested study version. Use `/v17.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms` for the active endpoint.",
"operationId":"getForms_17",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response detail level (`summary` or `details`). Optional.",
"schema":{
"type":"string",
"default":"summary"
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV4"
}
},
"examples":{
"listVisitFormsV4Response":{
"description":"listVisitFormsV4Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-forms-get"
},
"put":{
"tags":[
"Designer/Visit APIs/Visit Forms/Replace visit forms"
],
"summary":"V4.0",
"description":"Replaces forms on a visit for the requested study version. Use the latest supported version of this endpoint in v17.0 for current behavior and metadata.",
"operationId":"updateForms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"List of form IDs to associate with the visit. Required.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"replaceVisitFormsV4Request":{
"description":"replaceVisitFormsV4Request",
"value":[
"B1B8327AFAA6412287106192AB5984EF",
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV4"
}
},
"examples":{
"replaceVisitFormsV4Response":{
"description":"replaceVisitFormsV4Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-put",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-forms-put"
},
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Remove multiple visit forms"
],
"summary":"V4.0",
"description":"Removes selected forms from a visit or removes all forms when payload is omitted.",
"operationId":"removeForms_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
}
],
"requestBody":{
"description":"Form IDs to remove from the visit. Omit or pass null to remove all forms.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"type":"string"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
]
}
}
}
}
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV4"
}
},
"examples":{
"removeVisitFormsV4Response":{
"description":"removeVisitFormsV4Response",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-delete",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-forms-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms/{formId}":{
"delete":{
"tags":[
"Designer/Visit APIs/Visit Forms/Remove visit form"
],
"summary":"V4.0",
"description":"Removes one form from a visit for the requested study version. Use the latest supported version of this endpoint in v17.0 for current behavior and metadata.",
"operationId":"removeForm_3",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"formId",
"in":"path",
"description":"Form ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitFormDtoV4"
}
},
"examples":{
"removeVisitFormV4Response":{
"description":"removeVisitFormV4Response",
"value":{
"result":[
{
"visitId":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77",
"formId":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-{formId}-delete",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visits-visitid-forms-formid-delete"
}
},
"/ec-designer-svc/rest/v4.0/studies/{studyId}/versions/{version}/visitschedules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule"
],
"summary":"[Deprecated]: V4.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule of a study.",
"operationId":"getVisitSchedule_5",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"unscheduledVisits",
"in":"query",
"description":"Include unscheduled visit or not.",
"required":true,
"schema":{
"type":"string",
"default":"include"
},
"example":"include"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV2"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v4.0-studies-{studyId}-versions-{version}-visitschedules-get",
"x-filename-id":"ec-designer-svc-rest-v4.0-studies-studyid-versions-version-visitschedules-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/forms/{formId}/items":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get questions for a form"
],
"summary":"V5.0",
"description":"Retrieves questions associated with a specific form.",
"operationId":"getItems_4",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-items-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-items-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form Item/Add a question in a form"
],
"summary":"V5.0",
"description":"Adds a question to a specific form in a study.",
"operationId":"addItem_4",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Form item payload used to create a new form item.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-items-post",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-items-post"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/forms/{formId}/items/{itemId}":{
"get":{
"tags":[
"Designer/Form APIs/Form Item/Get a question for a form"
],
"summary":"V5.0",
"description":"Retrieves a specific question associated with a form.",
"operationId":"getItem_4",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-items-itemid-get"
},
"put":{
"tags":[
"Designer/Form APIs/Form Item/Update a question in a form"
],
"summary":"V5.0",
"description":"Updates a question included in a form in a study.",
"operationId":"updateItem_4",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"requestBody":{
"description":"Form item payload with updated values.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV5"
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/FormItemDtoV5"
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-put",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-items-itemid-put"
},
"delete":{
"tags":[
"Designer/Form APIs/Form Item/Delete a question from a form"
],
"summary":"V5.0",
"description":"Removes a question from a specific form in a study.",
"operationId":"deleteItem_4",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"itemId",
"in":"path",
"description":"Item identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"6F4A6C7E1B8F4D56A23C9F3A0C7D4E55"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-items-{itemId}-delete",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-items-itemid-delete"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Get visits associated with a form"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves visits associated with a specific form in a study.",
"operationId":"getVisits",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV1"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-visits-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Process visits to associate with a specific form"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Processes visits to be associated with a specific form in a study.",
"operationId":"processFormVisits",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of form-visit payloads used to associate visits with a form.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV1"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-forms-formid-visits-post"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a study"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves all forms in a study for a specific study version.",
"operationId":"getForms_29",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response detail level (`summary` or `details`). Optional.",
"schema":{
"type":"string",
"default":"summary"
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV5"
}
},
"examples":{
"listVisitFormsV5Response":{
"description":"listVisitFormsV5Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/visitschedules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule"
],
"summary":"[Deprecated]: V5.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule of a study.",
"operationId":"getVisitSchedule_10",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"unscheduledVisits",
"in":"query",
"description":"Include unscheduled visit or not.",
"required":true,
"schema":{
"type":"string",
"default":"include"
},
"example":"include"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v5.0-studies-{studyId}-versions-{version}-visitschedules-get",
"x-filename-id":"ec-designer-svc-rest-v5.0-studies-studyid-versions-version-visitschedules-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/forms/{formId}/visits":{
"get":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Get visits associated with a form"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves visits associated with a specific form in a study.",
"operationId":"getVisits_6",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV6"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-forms-formid-visits-get"
},
"post":{
"tags":[
"Designer/Form APIs/Form-Visit Association/Process visits to associate with a specific form"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Processes visits to be associated with a specific form in a study.",
"operationId":"processFormVisits_6",
"parameters":[
{
"name":"formId",
"in":"path",
"description":"Form identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11"
},
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
}
],
"requestBody":{
"description":"Array of form-visit payloads used to associate visits with a form.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormVisitDtoV6"
}
},
"examples":{
"requestExample":{
"description":"requestExample",
"value":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"name":"Demographics",
"title":"Demographics"
}
]
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":"success"
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-forms-{formId}-visits-post",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-forms-formid-visits-post"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/visits/{visitid}/forms":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Forms/Get list of forms in a study"
],
"summary":"V6.0",
"description":"Retrieves all forms in a study for a specific study version.",
"operationId":"getForms_18",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"visitid",
"in":"path",
"description":"Visit ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
},
"example":"9F4A6C7E1B8F4D56A23C9F3A0C7D4E77"
},
{
"name":"response",
"in":"query",
"description":"Response detail level (`summary` or `details`). Optional.",
"schema":{
"type":"string",
"default":"summary"
},
"example":"summary"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormDtoV7"
}
},
"examples":{
"listVisitFormsV6Response":{
"description":"listVisitFormsV6Response",
"value":{
"result":[
{
"id":"2F9A6C7E1B8F4D56A23C9F3A0C7D4E11",
"title":"Demographics",
"visitName":"Screening"
}
]
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visits-{visitid}-forms-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visits-visitid-forms-get"
}
},
"/ec-designer-svc/rest/v6.0/studies/{studyId}/versions/{version}/visitschedules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule"
],
"summary":"[Deprecated]: V6.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule of a study.",
"operationId":"getVisitSchedule_11",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"unscheduledVisits",
"in":"query",
"description":"Whether to include unscheduled visit or not.",
"required":true,
"schema":{
"type":"string",
"default":"include"
},
"example":"include"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV5"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v6.0-studies-{studyId}-versions-{version}-visitschedules-get",
"x-filename-id":"ec-designer-svc-rest-v6.0-studies-studyid-versions-version-visitschedules-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/arms/{armId}/dispensings":{
"get":{
"tags":[
"Designer/Treatment Arms APIs/Get list of treatment arm dispensations in a study version"
],
"summary":"V7.0",
"description":"Retrieves a list of treatment arm dispensations for a study version.",
"operationId":"getDispensings_23",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"armId",
"in":"path",
"description":"Treatment arm identifier (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"type":"string"
},
"example":"B1B8327AFAA6412287106192AB5984EF"
},
{
"name":"kitType",
"in":"query",
"description":"Type of kits requested: `standard`, `titration`, `device`, or `all`. Optional.",
"schema":{
"type":"string",
"default":"ALL"
},
"example":"ALL"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RespArmKitVisitDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"7A4D3C2B1E8F4D56A23C9F3A0C7D4E22",
"name":"Starter Kit",
"kitType":"standard"
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-arms-{armId}-dispensings-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-arms-armid-dispensings-get"
}
},
"/ec-designer-svc/rest/v7.0/studies/{studyId}/versions/{version}/visitschedules":{
"get":{
"tags":[
"Designer/Visit APIs/Visit Schedule/Get visit schedule"
],
"summary":"[Deprecated]: V7.0",
"description":"Deprecated: Use latest version instead. Retrieves the visit schedule of a study.",
"operationId":"getVisitSchedule_12",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID (UUID, 32-character uppercase hexadecimal string). Required.",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"format":"uuid"
},
"example":"F054C951EB74443C93716CA714AB686E"
},
{
"name":"version",
"in":"path",
"description":"Study version path segment. Required. Example: \"1.0.0.1\".",
"required":true,
"schema":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"1.0.0.1"
},
"example":"1.0.0.1"
},
{
"name":"unscheduledVisits",
"in":"query",
"description":"Whether to include unscheduled visit or not.",
"required":true,
"schema":{
"type":"string",
"default":"include"
},
"example":"include"
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StudyVisitScheduleDtoV7"
}
},
"examples":{
"successResponse":{
"description":"successResponse",
"value":{
"result":{
"id":"6D3A9B2E5C1F4A77B22D5E9F1A8C3344",
"name":"Baseline",
"day":1
}
}
}
}
}
}
},
"500":{
"description":"Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"deprecated":true,
"x-internal-id":"ec-designer-svc-rest-v7.0-studies-{studyId}-versions-{version}-visitschedules-get",
"x-filename-id":"ec-designer-svc-rest-v7.0-studies-studyid-versions-version-visitschedules-get"
}
},
"/ec-coding-svc/rest/v1.0/studies/{studyId}/{mode}/verbatimTerms":{
"get":{
"tags":[
"Coding/Verbatim Terms/Get list of verbatim terms to code"
],
"summary":"v1.0",
"description":"Retrieves the list of verbatim terms to be coded with datafilter, bookmark and number of records needed.",
"operationId":"getValuesToCode",
"parameters":[
{
"name":"startingTargetItem",
"in":"query",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"maxTargetItems",
"in":"query",
"schema":{
"type":"integer",
"format":"int32"
}
},
{
"name":"bookMark",
"in":"query",
"schema":{
"type":"string"
}
},
{
"name":"dataFilter",
"in":"query",
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/xml":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/AutoCodeResp"
}
}
}
}
},
"400":{
"description":"Bad Request",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/AutoCodeResp"
}
}
}
}
},
"x-internal-id":"ec-coding-svc-rest-v1.0-studies-{studyId}-{mode}-verbatimTerms-get",
"x-filename-id":"ec-coding-svc-rest-v1.0-studies-studyid-mode-verbatimterms-get"
}
},
"/ec-coding-svc/rest/v1.0/studies/{studyId}/{mode}/codedValues":{
"put":{
"tags":[
"Coding/Verbatim Terms/Update status of created queries or discrepancies"
],
"summary":"v1.0",
"description":"Updates coded verbatim terms back in forms.",
"operationId":"updateCodedValues",
"requestBody":{
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/PutCodingDataReq"
}
}
}
},
"responses":{
"200":{
"description":"Success",
"content":{
"application/xml":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/AutoCodeResp"
}
}
}
}
},
"400":{
"description":"Bad Request",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/AutoCodeResp"
}
}
}
}
},
"x-internal-id":"ec-coding-svc-rest-v1.0-studies-{studyId}-{mode}-codedValues-put",
"x-filename-id":"ec-coding-svc-rest-v1.0-studies-studyid-mode-codedvalues-put"
}
},
"/ec-coding-svc/rest/v1.0/studies/{studyId}/{mode}/query":{
"put":{
"tags":[
"Coding/Query Resource/Update status of created queries or discrepancies"
],
"summary":"v1.0",
"description":"Updates the status of Central Coding created queries or discrepancies. Allowed statuses are open, close, delete.",
"operationId":"updateCodedValues_1",
"requestBody":{
"description":"Query update request with status, revision and discrepancy ID.",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/UpdateRequest"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success",
"content":{
"application/xml":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/UpdateResponse"
}
}
}
}
},
"400":{
"description":"Bad Request",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/UpdateResponse"
}
}
}
}
},
"x-internal-id":"ec-coding-svc-rest-v1.0-studies-{studyId}-{mode}-query-put",
"x-filename-id":"ec-coding-svc-rest-v1.0-studies-studyid-mode-query-put"
},
"post":{
"tags":[
"Coding/Query Resource/Create queries or discrepancies"
],
"summary":"v1.0",
"description":"Creates Central Coding queries or discrepancies. Allowed status is open.",
"operationId":"createQuery",
"requestBody":{
"description":"Query issue request with status, revision and discrepancy ID.",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/IssueRequest"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Success",
"content":{
"application/xml":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/IssueResponse"
}
}
}
}
},
"400":{
"description":"Bad Request",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/IssueResponse"
}
}
}
}
},
"x-internal-id":"ec-coding-svc-rest-v1.0-studies-{studyId}-{mode}-query-post",
"x-filename-id":"ec-coding-svc-rest-v1.0-studies-studyid-mode-query-post"
}
},
"/ec-coding-svc/rest/v1.0/studies/{studyId}/{mode}/query/transaction":{
"get":{
"tags":[
"Coding/Query Resource/Get query details on a verbatim term from Clinical One"
],
"summary":"v1.0",
"description":"Retrieves query details using transaction ID from Central Coding.",
"operationId":"getQueryDetails",
"parameters":[
{
"name":"transactionId",
"in":"query",
"description":"Query update request with status, revision and discrepancy ID.",
"required":true,
"schema":{
"type":"string"
}
}
],
"responses":{
"200":{
"description":"Success",
"content":{
"application/xml":{
"schema":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DetailByTransactionIdResponse"
}
}
}
}
},
"400":{
"description":"Bad Request",
"content":{
"application/xml":{
"schema":{
"$ref":"#/components/schemas/DetailByTransactionIdResponse"
}
}
}
}
},
"x-internal-id":"ec-coding-svc-rest-v1.0-studies-{studyId}-{mode}-query-transaction-get",
"x-filename-id":"ec-coding-svc-rest-v1.0-studies-studyid-mode-query-transaction-get"
}
},
"/ec-coding-svc/rest/v1.0/studies/{studyId}/{mode}/query/discrepancy":{
"post":{
"tags":[
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],
"summary":"v1.0",
"description":"Retrieves details of a query raised in Central Coding using discrepancy ID and revision number.",
"operationId":"queryHistoryDetailsByDiscrepancyId",
"requestBody":{
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/DiscrepancyListRequest"
}
}
}
},
"responses":{
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"content":{
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"items":{
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}
},
"400":{
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"content":{
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}
},
"x-internal-id":"ec-coding-svc-rest-v1.0-studies-{studyId}-{mode}-query-discrepancy-post",
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},
"/ec-comment-svc/rest/v1.0/studies/{studyId}/comments":{
"post":{
"tags":[
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],
"summary":"V1.0",
"description":"Adds a comment or reply to an object's comment section.",
"operationId":"createComment_1",
"parameters":[
{
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"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"The comment to add.",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/CommentsDtoV1"
}
}
},
"required":true
},
"responses":{
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"description":"Successful operation.",
"content":{
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}
}
},
"500":{
"description":"Error",
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}
},
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},
"/ec-comment-svc/rest/v1.0/studies/{studyId}/comments/{commentId}":{
"put":{
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],
"summary":"V1.0",
"description":"Updates a particular comment or reply. Updates either its content or marks it as resolved.",
"operationId":"updateComment_1",
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{
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"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"commentId",
"in":"path",
"description":"The object ID associated to the comment.",
"required":true,
"schema":{
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"format":"uuid"
}
}
],
"requestBody":{
"description":"The comment to update.",
"content":{
"*/*":{
"schema":{
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}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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}
}
},
"500":{
"description":"Error",
"content":{
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}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-{commentId}-put",
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},
"delete":{
"tags":[
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],
"summary":"V1.0",
"description":"Deletes a comment or a reply from an object or comment chain.",
"operationId":"deleteComment_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"commentId",
"in":"path",
"description":"The object ID associated to the comment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation."
},
"500":{
"description":"Error",
"content":{
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"schema":{
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}
}
}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-{commentId}-delete",
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},
"/ec-comment-svc/rest/v1.0/studies/{studyId}/comments/objects/{objectId}":{
"get":{
"tags":[
"Comments/Get all comments for an object"
],
"summary":"V1.0",
"description":"Retrieves all comments and replies for a particular object.",
"operationId":"getAllCommentsByObjectId_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"objectId",
"in":"path",
"description":"The object ID associated to the comment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/CommentDto"
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-objects-{objectId}-get",
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}
},
"/ec-comment-svc/rest/v1.0/studies/{studyId}/comments/objects":{
"post":{
"tags":[
"Comments/Post comment or reply"
],
"summary":"V1.0",
"description":"Posts a comment or reply on a specific object.",
"operationId":"getAllCommentsByObjectIds_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"The comment to post.",
"content":{
"*/*":{
"schema":{
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"items":{
"type":"string"
}
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"schema":{
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}
}
}
},
"500":{
"description":"Error",
"content":{
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"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-objects-post",
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},
"/ec-comment-svc/rest/v1.0/studies/{studyId}/comments/objects/{objectId}/unreadCount":{
"get":{
"tags":[
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],
"summary":"V1.0",
"description":"Retrieves unread comments and replies count for a particular object.",
"operationId":"getUnreadCommentsCountByObjectId_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
},
{
"name":"objectId",
"in":"path",
"description":"The object ID associated to the comment.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"responses":{
"200":{
"description":"Successful operation.",
"content":{
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"schema":{
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"format":"int32"
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-objects-{objectId}-unreadCount-get",
"x-filename-id":"ec-comment-svc-rest-v1.0-studies-studyid-comments-objects-objectid-unreadcount-get"
}
},
"/ec-comment-svc/rest/v1.0/studies/{studyId}/comments/objects/unreadCount":{
"post":{
"tags":[
"Comments/Get unread comments count for a list of objects"
],
"summary":"V1.0",
"description":"Retrieves unread comments count and replies for a list of objects.",
"operationId":"getUnreadCommentsCountByObjectIds_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"The object ID associated to the comment.",
"content":{
"*/*":{
"schema":{
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"items":{
"type":"string"
}
}
}
},
"required":true
},
"responses":{
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"description":"Successful operation.",
"content":{
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"schema":{
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"format":"int32"
}
}
}
},
"500":{
"description":"Error",
"content":{
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"schema":{
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}
}
}
}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-objects-unreadCount-post",
"x-filename-id":"ec-comment-svc-rest-v1.0-studies-studyid-comments-objects-unreadcount-post"
}
},
"/ec-comment-svc/rest/v1.0/studies/{studyId}/comments/markAsRead":{
"post":{
"tags":[
"Comments/Mark comments as read for a user"
],
"summary":"V1.0",
"description":"Marks comments as read for the given user.",
"operationId":"markAsRead_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"List of comments which need to be marked as read",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/CommentsReadDtoV1"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"integer",
"format":"int32"
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
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}
}
}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-markAsRead-post",
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}
},
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"post":{
"tags":[
"Comments/Mark comments as unread for a user"
],
"summary":"V1.0",
"description":"Marks comments as unread for the given user.",
"operationId":"markAsUnRead_1",
"parameters":[
{
"name":"studyId",
"in":"path",
"description":"Study ID. Example: F054C951EB74443C93716CA714AB686E.",
"required":true,
"schema":{
"type":"string",
"format":"uuid"
}
}
],
"requestBody":{
"description":"List of comments which need to be marked as unread",
"content":{
"*/*":{
"schema":{
"$ref":"#/components/schemas/CommentsReadDtoV1"
}
}
},
"required":true
},
"responses":{
"200":{
"description":"Successful operation.",
"content":{
"application/json":{
"schema":{
"type":"integer",
"format":"int32"
}
}
}
},
"500":{
"description":"Error",
"content":{
"application/json":{
"schema":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
}
}
},
"x-internal-id":"ec-comment-svc-rest-v1.0-studies-{studyId}-comments-markAsUnRead-post",
"x-filename-id":"ec-comment-svc-rest-v1.0-studies-studyid-comments-markasunread-post"
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}
},
"components":{
"schemas":{
"JobStatusEntry":{
"required":[
"jobId",
"jobStatus",
"ruleId"
],
"type":"object",
"properties":{
"ruleId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the rule. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"E4C2D1B7A8F9465FB1E2A3C4D5879E10"
},
"jobId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the rule execution job. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"91F4E249F44C4C14A372EE30CEA6B7A8"
},
"jobStatus":{
"maxLength":64,
"minLength":4,
"type":"string",
"description":"Execution outcome for an individual rule job. Allowed values: Running (job currently executing), Success (job completed without errors), Failed (job exited because of an error), Cancelled (job was cancelled before completion), Completed with errors (job finished but produced warnings), Pending (job waiting to start), Rule is not in publish state (rule not promoted to the target mode), Rule is invalid (rule failed validation), Rule is disabled (rule disabled for the selected mode), Rule doesn't exist (referenced rule is missing), Failed to cancel job (service could not cancel the job), Skipped because subject is locked (subject lock prevented execution).",
"example":"Success",
"enum":[
"Running",
"Success",
"Failed",
"Cancelled",
"Completed with errors",
"Pending",
"Rule is not in publish state",
"Rule is invalid",
"Rule is disabled",
"Rule doesn't exist",
"Failed to cancel job",
"Skipped because subject is locked"
]
},
"ruleName":{
"maxLength":256,
"minLength":1,
"type":"string",
"description":"Rule display name associated with the job execution.",
"example":"onesection - create query with form submit dates"
},
"jobStartDate":{
"maxLength":23,
"minLength":23,
"pattern":"^\\d{4}-\\d{2}-\\d{2} \\d{2}:\\d{2}:\\d{2}\\.\\d{3}$",
"type":"string",
"description":"Job start timestamp formatted as yyyy-MM-dd HH:mm:ss.SSS in the service timezone.",
"example":"2025-09-07 19:12:08.747"
},
"groupJobId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the batch job that orchestrated this individual execution. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"589F499D700340DE866C8EF3ACCE1547"
}
},
"description":"Single rule execution job status entry.",
"example":{
"ruleId":"DBF2C278385E4AF4BA4FBF2AA76D194F",
"jobId":"91F4E249F44C4C14A372EE30CEA6B7A8",
"jobStatus":"Success",
"ruleName":"onesection - create query with form submit dates",
"jobStartDate":"2025-09-07 19:12:08.747",
"groupJobId":"F8491962C1574F0A89195560670B59E8"
}
},
"JobStatusResponse":{
"required":[
"errorMessage"
],
"type":"object",
"properties":{
"jobStatus":{
"type":"array",
"description":"Array of job status entries returned by the rule execution service. Allowed job status values: Running, Success, Failed, Cancelled, Completed with errors, Pending, Rule is not in publish state, Rule is invalid, Rule is disabled, Rule doesn't exist, Failed to cancel job, Skipped because subject is locked.",
"example":[
{
"ruleId":"DBF2C278385E4AF4BA4FBF2AA76D194F",
"jobId":"91F4E249F44C4C14A372EE30CEA6B7A8",
"jobStatus":"Success",
"ruleName":"onesection - create query with form submit dates",
"jobStartDate":"2025-09-07 19:12:08.747",
"groupJobId":"F8491962C1574F0A89195560670B59E8"
}
],
"items":{
"$ref":"#/components/schemas/JobStatusEntry"
}
},
"errorMessage":{
"maxLength":512,
"minLength":1,
"type":"string",
"description":"Overall outcome for the job status request. Provide \"Success\" when all jobs were evaluated successfully; otherwise supply a concise explanation of the failure.",
"example":"Success"
}
},
"description":"Response payload returned by rule job status endpoints."
},
"RuleIdsTO":{
"title":"Rule IDs Object",
"type":"object",
"properties":{
"ruleIds":{
"type":"array",
"description":"Ordered collection of rule identifiers to include. Provide between one and five hundred values.",
"example":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
],
"items":{
"maxLength":32,
"minLength":32,
"pattern":"^[0-9A-F]{32}$",
"type":"string",
"description":"32-character uppercase hexadecimal rendering of a rule UUID. Dashes and lowercase letters are rejected.",
"example":"938D23FA6B7241CCA41BD627E5DB60DA"
}
}
},
"description":"Object containing a list of Rule IDs"
},
"RuleIdsRequest":{
"type":"object",
"properties":{
"ruleIds":{
"type":"array",
"description":"Ordered collection of rule identifiers to include. Provide between one and five hundred values.",
"example":[
"0E1A63683F884B13A3E7BEE9CA4FF1EA",
"DBF2C278385E4AF4BA4FBF2AA76D194F"
],
"items":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Rule UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"example":"E4C2D1B7A8F9465FB1E2A3C4D5879E10"
}
}
},
"description":"List of rule identifiers supplied to the re-execution APIs."
},
"RuleHistoryEntry":{
"required":[
"jobId",
"ruleId"
],
"type":"object",
"properties":{
"ruleId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the rule. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"704A7178208D44BC9AD52556B18933C3"
},
"jobId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the rule execution job. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"0E2428167F66445BAB544C7CDD884E87"
},
"jobStatus":{
"maxLength":64,
"minLength":4,
"type":"string",
"description":"Execution outcome for an individual rule job. Allowed values: Running (job currently executing), Success (job completed without errors), Failed (job exited because of an error), Cancelled (job was cancelled before completion), Completed with errors (job finished but produced warnings), Pending (job waiting to start), Rule is not in publish state (rule not promoted to the target mode), Rule is invalid (rule failed validation), Rule is disabled (rule disabled for the selected mode), Rule doesn't exist (referenced rule is missing), Failed to cancel job (service could not cancel the job), Skipped because subject is locked (subject lock prevented execution).",
"example":"Success",
"enum":[
"Running",
"Success",
"Failed",
"Cancelled",
"Completed with errors",
"Pending",
"Rule is not in publish state",
"Rule is invalid",
"Rule is disabled",
"Rule doesn't exist",
"Failed to cancel job",
"Skipped because subject is locked"
]
},
"ruleName":{
"maxLength":256,
"minLength":1,
"type":"string",
"description":"Rule display name associated with the historical job execution.",
"example":"screening - create query with form submit dates"
},
"jobStartDate":{
"maxLength":23,
"minLength":23,
"pattern":"^\\d{4}-\\d{2}-\\d{2} \\d{2}:\\d{2}:\\d{2}\\.\\d{3}$",
"type":"string",
"description":"Job start timestamp formatted as yyyy-MM-dd HH:mm:ss.SSS in the service timezone.",
"example":"2025-09-07 19:08:07.437"
},
"userId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the user that initiated the rule execution. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"0000000000000000000000000000000A"
},
"countPassedSubjects":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"Number of subjects for which the rule passed. Negative values are not allowed.",
"format":"int32",
"example":1
},
"countFailedSubjects":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"Number of subjects for which the rule failed. Negative values are not allowed.",
"format":"int32",
"example":0
}
},
"description":"Individual rule re-run history entry.",
"example":{
"ruleId":"704A7178208D44BC9AD52556B18933C3",
"jobId":"0E2428167F66445BAB544C7CDD884E87",
"jobStatus":"Success",
"ruleName":"screening - create query with form submit dates",
"jobStartDate":"2025-09-07 19:08:07.437",
"userId":"0000000000000000000000000000000A",
"countPassedSubjects":1,
"countFailedSubjects":0
}
},
"RuleHistoryResponse":{
"required":[
"status"
],
"type":"object",
"properties":{
"ruleHistory":{
"type":"array",
"description":"Collection of rule history entries returned for the provided rule identifier.",
"example":[
{
"ruleId":"704A7178208D44BC9AD52556B18933C3",
"jobId":"0E2428167F66445BAB544C7CDD884E87",
"jobStatus":"Success",
"ruleName":"screening - create query with form submit dates",
"jobStartDate":"2025-09-07 19:08:07.437",
"userId":"0000000000000000000000000000000A",
"countPassedSubjects":1,
"countFailedSubjects":0
}
],
"items":{
"$ref":"#/components/schemas/RuleHistoryEntry"
}
},
"status":{
"maxLength":32,
"minLength":4,
"type":"string",
"description":"High-level status for the history request. Values: SUCCESS (history retrieved successfully), VALIDATION_ERROR (request failed validation), NOT_FOUND (no matching history records), SERVER_ERROR (unexpected service failure).",
"example":"SUCCESS",
"enum":[
"SUCCESS",
"VALIDATION_ERROR",
"NOT_FOUND",
"SERVER_ERROR"
]
},
"statusDetail":{
"maxLength":512,
"minLength":1,
"type":"string",
"description":"Additional detail about the rule history status. Null when the request succeeds without warnings.",
"nullable":true,
"example":"Rule execution job not found for the supplied identifier."
}
},
"description":"Envelope returned when fetching rule history by rule identifier."
},
"JobStatusEntryV2":{
"required":[
"jobId",
"jobStatus",
"ruleId"
],
"type":"object",
"properties":{
"ruleId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the rule. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"E4C2D1B7A8F9465FB1E2A3C4D5879E10"
},
"jobId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the rule execution job. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"91F4E249F44C4C14A372EE30CEA6B7A8"
},
"jobStatus":{
"maxLength":64,
"minLength":4,
"type":"string",
"description":"Execution outcome for an individual rule job. Allowed values: Running (job currently executing), Success (job completed without errors), Failed (job exited because of an error), Cancelled (job was cancelled before completion), Completed with errors (job finished but produced warnings), Pending (job waiting to start), Rule is not in publish state (rule not promoted to the target mode), Rule is invalid (rule failed validation), Rule is disabled (rule disabled for the selected mode), Rule doesn't exist (referenced rule is missing), Failed to cancel job (service could not cancel the job), Skipped because subject is locked (subject lock prevented execution).",
"example":"Success",
"enum":[
"Running",
"Success",
"Failed",
"Cancelled",
"Completed with errors",
"Pending",
"Rule is not in publish state",
"Rule is invalid",
"Rule is disabled",
"Rule doesn't exist",
"Failed to cancel job",
"Skipped because subject is locked"
]
},
"ruleName":{
"maxLength":256,
"minLength":1,
"type":"string",
"description":"Rule display name associated with the job execution.",
"example":"onesection - create query with form submit dates"
},
"jobStartDate":{
"maxLength":23,
"minLength":23,
"pattern":"^\\d{4}-\\d{2}-\\d{2} \\d{2}:\\d{2}:\\d{2}\\.\\d{3}$",
"type":"string",
"description":"Job start timestamp formatted as yyyy-MM-dd HH:mm:ss.SSS in the service timezone.",
"example":"2025-09-07 19:12:08.747"
},
"groupJobId":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Identifier for the batch job that orchestrated this individual execution. Accepts either a compact 32-character hexadecimal UUID or a hyphenated 36-character UUID.",
"example":"589F499D700340DE866C8EF3ACCE1547"
}
},
"description":"Single rule execution job status entry (version 2.0).",
"example":{
"ruleId":"DBF2C278385E4AF4BA4FBF2AA76D194F",
"jobId":"91F4E249F44C4C14A372EE30CEA6B7A8",
"jobStatus":"Success",
"ruleName":"onesection - create query with form submit dates",
"jobStartDate":"2025-09-07 19:12:08.747",
"groupJobId":"F8491962C1574F0A89195560670B59E8"
}
},
"JobStatusResponseV2":{
"required":[
"errorMessage"
],
"type":"object",
"properties":{
"jobStatus":{
"type":"array",
"description":"Array of job status entries returned by the rule execution service. Allowed job status values: Running, Success, Failed, Cancelled, Completed with errors, Pending, Rule is not in publish state, Rule is invalid, Rule is disabled, Rule doesn't exist, Failed to cancel job, Skipped because subject is locked.",
"example":[
{
"ruleId":"DBF2C278385E4AF4BA4FBF2AA76D194F",
"jobId":"91F4E249F44C4C14A372EE30CEA6B7A8",
"jobStatus":"Success",
"ruleName":"onesection - create query with form submit dates",
"jobStartDate":"2025-09-07 19:12:08.747",
"groupJobId":"F8491962C1574F0A89195560670B59E8"
}
],
"items":{
"$ref":"#/components/schemas/JobStatusEntryV2"
}
},
"errorMessage":{
"maxLength":512,
"minLength":1,
"type":"string",
"description":"Overall outcome for the job status request. Provide \"Success\" when all jobs were evaluated successfully; otherwise supply a concise explanation of the failure.",
"example":"Success"
}
},
"description":"Response payload returned by rule job status endpoints in version 2.0."
},
"RuleIdsRequestV2":{
"type":"object",
"properties":{
"ruleIds":{
"type":"array",
"description":"Ordered collection of rule identifiers to include. Provide between one and five hundred values.",
"example":[
"0E1A63683F884B13A3E7BEE9CA4FF1EA",
"DBF2C278385E4AF4BA4FBF2AA76D194F"
],
"items":{
"maxLength":36,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$|^[0-9A-Fa-f]{8}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{4}-[0-9A-Fa-f]{12}$",
"type":"string",
"description":"Rule UUID. Accepts either a compact 32-character hexadecimal value or a hyphenated 36-character UUID.",
"example":"E4C2D1B7A8F9465FB1E2A3C4D5879E10"
}
}
},
"description":"List of rule identifiers supplied to version 2.0 re-execution APIs."
},
"DataElementValidationDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element given in format of UUID.",
"example":"64C57ED1076F47078C8E5AD537244989"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"C5E90E4184BC4205978759A808245E98"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"9A201C440D40426080C825762206D64B"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"12197E724A1C47C8A740153E5948AB19"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"F7F805CA51B545BFB5808EF7952ED597"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":2
},
"repeatFormNumber":{
"type":"integer",
"description":"Form repeat number if applicable.",
"format":"int32",
"example":1
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"isSubjectLocked":{
"type":"boolean",
"description":"Whether the subject is locked for this record.",
"example":false
},
"isItemLocked":{
"type":"boolean",
"description":"Whether the item is locked for this record.",
"example":true
},
"isParentLocked":{
"type":"boolean",
"description":"Whether the parent is locked for this record.",
"example":false
},
"isItemFrozen":{
"type":"boolean",
"description":"Whether the item is frozen for this record.",
"example":true
}
},
"description":"Representing validation result/status for a specific data element instance, including lock and repeat status information."
},
"ErrorResponseData":{
"type":"object",
"properties":{
"errorCode":{
"type":"string"
},
"errorMessage":{
"type":"string"
},
"details":{
"type":"object"
}
}
},
"RestResponse":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"object"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"RestResponseListDataElementValidationDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementValidationDto"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElement":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the data element.",
"example":"B58C5C21BFC94E1384D0F4C6BA7566F3"
},
"transactionStart":{
"type":"string",
"description":"Date when the transaction for this element started.",
"example":"2023-01-20"
},
"transactionEnd":{
"type":"string",
"description":"Date when the transaction for this element ended.",
"example":"2023-01-21"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the study.",
"example":"Study Alpha"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABD123EFC6784123BBAA1122CCDDEE44"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BEEFAABBCCDDEEDDFF00112233445566"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"360E6122F84A43CAAF70E3BECC471A7C"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"4FB2D38F8F9644D2B3BE08B815A8FF1A"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Form repeat number if applicable.",
"format":"int64",
"example":0
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"itemId":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BEEFAABBCCDDEEDDFF00112233445566"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"E8EB947A8B684C8B8A30C6070A65BD76"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"D340A21830F6465C8466A2B42EF370D5"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Third-party system or vendor code, if imported.",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw string value for the data element (as entered/captured).",
"example":"102.1"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Unit of measurement for value field (e.g. mg, cm).",
"example":"mg"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"example":"C9E86AF896F04FBB82FB755666DA6B58"
},
"itemR":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"example result_R"
},
"itemF":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"example free-field"
},
"itemType":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Type/category of the item.",
"example":"NUMERIC"
},
"propertyId":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) of data capture properties",
"example":"FFBC9E118C4C48FDB77A50A1CDD28AA9"
},
"propertyVersionStart":{
"type":"string",
"description":"Start time (timestamp) for the property version.",
"format":"date-time",
"example":"2025-01-01T13:10:00Z"
},
"dataEventType":{
"type":"string",
"description":"Event occurs when a form is restored.",
"example":"FORM_RESTORED"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"D3C9A4B5E6F78123456789ABCDEF1234"
},
"lockedStatus":{
"type":"string",
"description":"Indicates if the field is locked.values applicable LOCKED, NEVER_LOCKED, UNLOCKED, NOT_APPLICABLE",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Date/time when lock was applied.",
"format":"date-time",
"example":"2025-05-20T10:30:00Z"
},
"visitStatus":{
"type":"string",
"description":"Visit status for this data element.",
"example":"INPROGRESS",
"enum":[
"NEW",
"COMPLETE",
"COMPLETE_ERR",
"INPROGRESS",
"INCOMPLETE",
"INCOMPLETE_ERR",
"SKIPPED",
"UNDO_SKIP",
"NOT_STARTED"
]
},
"visitStartDate":{
"type":"string",
"description":"Date when the visit started.",
"example":"2025-05-19"
},
"isSafetyTrigger":{
"type":"boolean",
"description":"Indicates if this triggers a safety-related workflow.",
"example":false
},
"isSafetyDefaultSelected":{
"type":"boolean",
"description":"Indicates if this safety field is default-selected.",
"example":true
},
"dataflagValue":{
"type":"string",
"description":"data flag applied, values which are applicable Not Done, Not Applicable, Unknown",
"example":"Not Done"
},
"documentId":{
"type":"string",
"description":"Unique identifier of the associated source document (hex UUID, 32-character uppercase), enabling traceability between the data element and its original supporting document or file.",
"example":"26C7C2DF6B2546E6BBA8331738FACD1E"
},
"validationRules":{
"type":"array",
"description":"Validation rules applied to this data element.",
"items":{
"$ref":"#/components/schemas/ValidationRuleDto"
}
}
},
"description":"Represents a data element as captured/stored for a subject during a study, including repeat and validation info."
},
"MultipleDataElementRequest":{
"required":[
"dataElements"
],
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"The list of data elements to validate.",
"items":{
"$ref":"#/components/schemas/DataElement"
}
}
},
"description":"Request DTO with a list of DataElement objects for multifield data validation."
},
"ValidationRuleDto":{
"type":"object",
"properties":{
"ruleId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) for the validation rule.",
"example":"45B982CDC4604AF5A354AAAF7BEEB93B"
},
"queryId":{
"type":"string",
"description":"Query identifier (UUID, 32-character uppercase hexadecimal string) generated by the validation rule.",
"example":"45B982CDC4604AF5A354AAAF7BEEB93B"
},
"queryStatus":{
"type":"string",
"description":"Status of the query associated with this rule and values can be Candidate, Answered, Closed, Opened, Deleted",
"example":"Opened"
}
},
"description":"Validation rule details associated with a specific data element."
},
"TwoSectionAndRepeatingFormValidationDto":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"64C57ED1076F47078C8E5AD537244989"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"64C57ED1076F47078C8E5AD537244989"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"64C57ED1076F47078C8E5AD537244989"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":1
},
"innerRepeatNum":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeatNum":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"isSubjectLocked":{
"type":"boolean",
"description":"Field representing the status of whether the Subject is locked or not.",
"example":true
},
"hasLockData":{
"type":"boolean",
"description":"Status showing subject has locked data",
"example":true
},
"hasFrozenData":{
"type":"boolean",
"description":"Status showing subject has frozen data",
"example":true
}
}
},
"VisitStartDateValidationDto":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"A1B2C3D4E5F60718293A4BCCFA7EE829"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B1ABA3F2E29F4EE193AB6A5DEEC1B5CA"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":5
},
"visitStartDateLocked":{
"type":"boolean",
"description":"Whether the visit start date is locked.",
"example":true
},
"visitLocked":{
"type":"boolean",
"description":"Whether the visit is locked.",
"example":false
}
},
"description":"Includes subjectId, eventId, eventInstanceNum, and boolean results indicating whether the visit and the visit start date are locked"
},
"RestResponseListVisitStartDateValidationDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitStartDateValidationDto"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"MultipleVisitRequest":{
"required":[
"visits"
],
"type":"object",
"properties":{
"visits":{
"type":"array",
"description":"The list of visit objects to validate.",
"items":{
"$ref":"#/components/schemas/VisitsDTO1"
}
}
},
"description":"Request DTO with a list of VisitsDTO objects for validating visit start dates across multiple visits."
},
"VisitsDTO1":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"D27DB9E0AFE349D7980683CF55A33883"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
}
},
"description":"Takes eventId and eventInstanceNum to uniquely reference a visit instance"
},
"CoreSignVerifyRequestDto":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Form repeat number if applicable.",
"format":"int64",
"example":0
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
}
},
"description":"DTO for a single data element to be signed/unverified as part of a bulk request."
},
"SignVerifyRequestDto":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"reason":{
"type":"string",
"description":"Reason for the operation, if supplied. Accepted values are Change for encoding, Incorrect Subject, Investigator Correction, Transcription Error, Other.",
"example":"Other"
},
"comment":{
"type":"string",
"description":"Any extra comment for the action when Other is selected in reason.",
"example":"The data required is missing."
},
"elements":{
"type":"array",
"description":"List of core sign/verify target elements.",
"items":{
"$ref":"#/components/schemas/CoreSignVerifyRequestDto"
}
}
},
"description":"Request for bulk unsign or unverify operations for a specific event/subject.",
"xml":{
"name":"signVerifyRequest"
}
},
"UnFreezeRequestDT02":{
"type":"object",
"properties":{
"reasonForChange":{
"type":"string",
"description":"A short description explaining the reason for the unfreeze action.",
"example":"Data Corrected"
},
"comment":{
"type":"string",
"description":"A comment explaining the unfreeze action.",
"example":"Requesting unfreeze due to updated laboratory data."
}
},
"description":"DTO for unfreezing a data element with reason and comment.",
"xml":{
"name":"unfreezeRequest"
}
},
"UnFreezeRequestVSD":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"comment":{
"type":"string",
"description":"A short comment explaining for the unfreeze action when Other is selected in reasonForChange",
"example":"comment"
},
"reasonForChange":{
"type":"string",
"description":"A short description explaining the reason for the unfreeze action. Accepted values are Change for encoding, Incorrect Subject, Investigator Correction, Transcription Error, Other.",
"example":"Other"
}
},
"description":"Superclass for unfreeze requests, contains the reason for unfreezing.",
"xml":{
"name":"UnFreezeRequestVSD"
}
},
"BulkActionDTO":{
"title":"BulkActionDTO",
"type":"object",
"properties":{
"filters":{
"$ref":"#/components/schemas/SubjectsVisitScheduleRequestV3"
},
"subjectIds":{
"type":"array",
"description":"List of Subject Ids. For visit lock/unlock in UUID format",
"format":"UUID",
"example":[
"6AF54DB79B764662B685D68C52AB0B84",
"6AF54DB79B764662B685D68C52AB0B84"
],
"items":{
"type":"string",
"description":"List of Subject Ids. For visit lock/unlock in UUID format",
"format":"uuid"
}
},
"visitIds":{
"type":"array",
"description":"List of visits mandatory for visit lock/unlock in UUID format",
"items":{
"$ref":"#/components/schemas/VisitsDTO1"
}
},
"reason":{
"type":"string",
"description":"reason for making current change",
"example":"other"
},
"comment":{
"type":"string",
"description":"comment for visit/subject unlock",
"example":"adding lists of other visits"
}
},
"description":"Information for bulk action"
},
"SubjectsVisitScheduleRequestV3":{
"type":"object",
"properties":{
"sites":{
"type":"array",
"description":"List of site identifiers to scope the search",
"example":[
"D3C9A4B5E6F78123456789ABCDEF1234",
"E1F2A3B4C5D6E7F89012ABCDEF345678"
],
"items":{
"type":"string",
"description":"List of site identifiers to scope the search",
"format":"uuid"
}
},
"limit":{
"type":"integer",
"description":"Maximum number of results to return",
"format":"int32",
"example":25
},
"offset":{
"type":"integer",
"description":"Offset for pagination",
"format":"int32",
"example":0
},
"order":{
"type":"string",
"description":"Sort order for results",
"example":"asc"
},
"reviewStatus":{
"type":"string",
"description":"Review status filter applied to subjects. Values can be noopenqueries, openqueries, verified, signed, locked, allvisitscomplete, readytosign, allvisitscomplete, readytoverify, all, signedandverified, frozen ",
"example":"all"
},
"subjectStates":{
"type":"array",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed",
"example":[
"Auto_Screen_Failed"
],
"items":{
"type":"string",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed",
"example":"[\"Auto_Screen_Failed\"]"
}
},
"exactSearchKeywords":{
"type":"array",
"description":"Keywords for exact match in subject search which will be applied on subject number",
"example":[
"1001",
"SMITH"
],
"items":{
"type":"string",
"description":"Keywords for exact match in subject search which will be applied on subject number",
"example":"[\"1001\",\"SMITH\"]"
}
},
"containsSearchKeywords":{
"type":"array",
"description":"Keywords for contains match in subject search which will be applied on subject number",
"example":[
"100",
"SMI"
],
"items":{
"type":"string",
"description":"Keywords for contains match in subject search which will be applied on subject number",
"example":"[\"100\",\"SMI\"]"
}
},
"nextVisitOnly":{
"type":"boolean",
"description":"When true, only the next scheduled visit is returned per subject",
"example":false
},
"notStarted":{
"type":"boolean",
"description":"When true, include only subjects that have not started",
"example":false
},
"safetyCaseStatus":{
"type":"string",
"description":"Indicates the safety case status filter. values can be SUBMITTED, CREATED, MODIFIED, SUBMIT_FAILED, CANCEL_FAILED, CANCELLED, DISMISSED, ACCEPTED, REJECTED, TRANSFER_FAILED, ALL.",
"example":"ALL"
},
"dmViewReviewStatus":{
"type":"array",
"description":"Review status for data management view.The acceptable values are: noopenqueries, openqueries, verified, signed, locked, allvisitscomplete, readytosign, allvisitscomplete, readytoverify.",
"example":[
"readytoverify"
],
"items":{
"type":"string",
"description":"Review status for data management view.The acceptable values are: noopenqueries, openqueries, verified, signed, locked, allvisitscomplete, readytosign, allvisitscomplete, readytoverify.",
"example":"[\"readytoverify\"]"
}
}
},
"description":"DTO for specifying filter and sorting options when scheduling visits for multiple subjects (bulk operations)."
},
"DataActionsDTO":{
"type":"object",
"properties":{
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"8877665544332211AABBCCDDEEFF0011"
},
"id":{
"type":"string",
"description":"Unique identifier for a data action given in UUID, 32-character uppercase hexadecimal string format.",
"example":"A1B23C45D67E89F123456789ABCDEF12"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T00:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-12-31T23:59:59Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"E1F2D3C4B5A697887766554433221100"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"format":"integer",
"example":2
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"format":"integer",
"example":3
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the data action.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments about the action.",
"example":"Lock applied due to protocol deviation"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"C9F84A1D5C7E42A8B9F56321A4B8D721"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"3EFD49D47C96428C9AAE2FDDE2A32D23"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"A1B23C45D67E89F123456789ABCDEF12"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":2
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"ABCDEFABCDEF1234567890ABCDEF1234"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Form repeat number if applicable.",
"format":"int64",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"action":{
"type":"string",
"description":"Action taken on the visit start date value.Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateAction":{
"type":"string",
"description":"Action performed on visit start date LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"UNLOCKED"
}
},
"description":"DTO representing details of a data action and locking operations."
},
"RestResponseListDataActionsDTO":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataActionsDTO"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"ItemsLockRequest":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"680F2514D67889ABCDEF112233ABCDEF"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"CA12B34DEA56B789C1789EFEDEE10988"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"12ABCD3421345678BACE1122CCFEDD11"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":2
}
},
"description":"Request element for locking/unlocking a specific item within a subject's visit."
},
"SubjectVisitsItemsLockRequest":{
"type":"object",
"properties":{
"visitItems":{
"type":"array",
"description":"List of ItemsLockRequest objects for each subject/visit/item to lock.",
"items":{
"$ref":"#/components/schemas/ItemsLockRequest"
}
}
},
"description":"Request payload for batch lock/unlock operations on subject visits/items."
},
"SubjectWithLockedDataDto":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of Unique Identifier(UUID, 32-character uppercase hexadecimal string) representing Subjects.",
"format":"uuid",
"example":[
"A1B23C45D67E89F123456789ABCDEF12",
"B2C34D56E78F90A123456789ABCDEF34"
],
"items":{
"type":"string",
"description":"List of Unique Identifier(UUID, 32-character uppercase hexadecimal string) representing Subjects.",
"format":"uuid"
}
}
},
"description":"DTO representing a response with a list of subject IDs who have locked data."
},
"RestResponseSubjectWithLockedDataDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectWithLockedDataDto"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"VisitLockDetails":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BA62DB18A9E347B899743D46853CEDCA"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"D3AE48BD29FC4E379BC94AB8265A72CF"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"lockStatus":{
"type":"string",
"description":"Lock status for this visit. applicable values are LOCKED, UNLOCKED",
"example":"LOCKED"
},
"lockStatusTime":{
"type":"string",
"description":"Timestamp when current lock status became effective.",
"format":"date-time",
"example":"2023-10-15T18:25:43Z"
},
"visitStartDateLockStatus":{
"type":"string",
"description":"Lock status for the visit start date. applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockStatusTime":{
"type":"string",
"description":"Timestamp when visitStartDateLockStatus was set.",
"format":"date-time",
"example":"2023-10-15T18:25:43Z"
}
},
"description":"DTO containing lock status details for a visit, including subject, event, lock statuses, and related timestamps."
},
"RestResponseVisitLockDetails":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/VisitLockDetails"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElementRequestDTO":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"AABBCCDDEEFF00112233445566778899"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BB112233445566778899AABBCCDDEEFF"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"EEFF00112233445566778899AABBCCDD"
}
},
"description":"DTO specifying a data elements (form, form section, item, or repeat) to be locked or unlocked in a visit."
},
"LockDTO":{
"type":"object",
"properties":{
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABD123EFC6784123BBAA1122CCDDEE44"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABD123EFC6784123BBAA1122CCDDEE44"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"BEEFAABBCCDDEEDDFF00112233445566"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"BEEFAABBCCDDEEDDFF00112233445566"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"lockVisitStartDate":{
"type":"string",
"description":"Start date for the locked visit.",
"example":"2023-01-01T09:00:00Z"
},
"elements":{
"type":"array",
"description":"List of data elements to lock.",
"items":{
"$ref":"#/components/schemas/DataElementRequestDTO"
}
}
},
"description":"DTO used to specify the parameters for locking visit elements for a subject/event/site."
},
"SubjectVisitsFormsItemsDTO":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"F5F6EA48B9D04C6F8C657CFA5A20EC53"
},
"events":{
"type":"array",
"description":"List of visit/form/item objects for the subject in UUID format.",
"items":{
"$ref":"#/components/schemas/VisitFormsItemsDTO"
}
}
},
"description":"DTO representing a subject and the list of events (visits/forms/items) to be locked."
},
"SubjectVisitsItemsResponseDTO":{
"type":"object",
"properties":{
"processedObjects":{
"type":"array",
"description":"List of successfully processed subject/visit/form/item objects.",
"items":{
"$ref":"#/components/schemas/SubjectVisitsFormsItemsDTO"
}
},
"failedObjects":{
"type":"array",
"description":"List of subject/visit/form/item objects which failed to process.",
"items":{
"$ref":"#/components/schemas/SubjectVisitsFormsItemsDTO"
}
},
"exceptions":{
"type":"array",
"description":"Exceptions or error messages for failed objects.",
"example":[
"Event not found for subject 18DFFBDF2523489AAF3DE9D6CA60B7F2"
],
"items":{
"type":"string",
"description":"Exceptions or error messages for failed objects.",
"example":"[\"Event not found for subject 18DFFBDF2523489AAF3DE9D6CA60B7F2\"]"
}
}
},
"description":"Response DTO for bulk lock operation, includes processed and failed objects"
},
"VisitFormsItemsDTO":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BCAF12ED87549BA59F7A43AB6A77C1E2"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"elements":{
"type":"array",
"description":"List of data element DTOs indicating forms/items under the visit.",
"items":{
"$ref":"#/components/schemas/DataElementRequestDTO"
}
}
},
"description":"DTO for event (visit) details including forms and items to be locked."
},
"ZKUnlockDto":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"b123fe17aac4410b9ab0137e6c88981a"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"91d1b34ed1904d8499844159776b2fd7"
},
"reason":{
"type":"string",
"description":"Reason for requesting this unlock.",
"example":"Other."
},
"comment":{
"type":"string",
"description":"Additional comment or context for the unlock request.",
"example":"Unlocking all visits except main subject lock due to CRA request."
}
},
"description":"Unlock DTO for unlocking all visits/items for a subject, except subject-level. All fields are optional."
},
"UnlockDTO":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"DDEEFF112233445566778899AABBCC00"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"CCBBAA99887766554433221100FFEEDD"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"0112233445566778899AABBCCDDEEFF0"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":2
},
"lockVisitStartDate":{
"type":"string",
"description":"Visit start date for the unlock operation.",
"example":"2023-12-01T12:00:00Z"
},
"elements":{
"type":"array",
"description":"List of Elements to unlock",
"items":{
"$ref":"#/components/schemas/UnlockElements"
}
},
"reason":{
"type":"string",
"description":"Reason information for why the unlock operation is being performed.",
"example":"Other"
},
"comment":{
"type":"string",
"description":"Additional comments about the unlock operation.",
"example":"Unlocked due to query resolution"
}
},
"description":"DTO representing unlock operation for elements/subjects/visits."
},
"UnlockElements":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"ABCDEFAB1234567890ABCDEFAB123456"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"7890ABCDEFAB1234DEFABC1234567890"
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"EFAB1234ABCDEF907890ABCDEFAB1234"
}
},
"description":"DTO describing a single data element to unlock, such as form, form section, item, or repeat."
},
"ReasonCommentRequest":{
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Incorrect entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Removing incorrect data captured by mistake"
}
},
"description":"Reason and comment to justify operation."
},
"SignConfigEligibilityResponseDTO":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the sign config eligibility record",
"example":"4F3A7FD6A91E4A5FAB1EA98387E82B6B"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"example":"2023-08-10T00:00:00.000Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-08-10T00:00:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"9AAECDD92E3F41C6AFD2B8FF1DD9CF22"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"format":"integer",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"format":"integer",
"example":3
},
"reason":{
"type":"string",
"description":"The reason for the current change.",
"example":"Other."
},
"comment":{
"type":"string",
"description":"Administrative comment regarding eligibility.",
"example":"Included after manual review."
},
"configId":{
"type":"string",
"description":"Signature configuration identifier (UUID, 32-character uppercase hexadecimal string).",
"example":"4E005942732C417D9B47C6ACBB3ACD65"
},
"requiredOn":{
"type":"string",
"description":"Indicates what element the eligibility is required on SUBJECT, FORM, CASEBOOK.",
"example":"FORM"
},
"affidavitCodeValue":{
"type":"string",
"description":"Code value for the affidavit if applicable.",
"example":"Electronic Signature Affidavit"
},
"requiredBy":{
"type":"array",
"description":"List of String of UUID(UUID, 32-character uppercase hexadecimal string) of user id roles or entities that require the eligibility.",
"example":[
"A1B23C45D67E89F123456789ABCDEF12",
"B2C34D56E78F90A123456789ABCDEF34"
],
"items":{
"type":"string",
"description":"List of String of UUID(UUID, 32-character uppercase hexadecimal string) of user id roles or entities that require the eligibility.",
"example":"[\"A1B23C45D67E89F123456789ABCDEF12\",\"B2C34D56E78F90A123456789ABCDEF34\"]"
}
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AABBCCDDEEFF00112233445566778899"
},
"subjectNumber":{
"type":"string",
"description":"Unique number representing subject within the study.",
"example":"SUBJ1067"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D27DB9E0AFE349D7980683CF55A33883"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"360E6122F84A43CAAF70E3BECC471A7C"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Form repeat number if applicable.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":2
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"4FB2D38F8F9644D2B3BE08B815A8FF1A"
},
"status":{
"type":"string",
"description":"Status associated with the eligibility and values can be readyToSign, signed",
"example":"readyToSign"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"actionStatus":{
"type":"string",
"description":"Current action status for the eligibility can view, sign.",
"example":"view"
},
"dueDays":{
"type":"integer",
"description":"Number of days the action is due.",
"format":"int32",
"example":3
},
"formTitle":{
"type":"string",
"description":"Title of the associated form.",
"example":"Informed Consent"
},
"visitTitle":{
"type":"string",
"description":"Title of the associated clinical visit.",
"example":"Visit 1"
}
},
"description":"containing detailed sign configuration eligibility information for a subject, form, and visit."
},
"SignInfoDTO":{
"type":"object",
"properties":{
"visits":{
"type":"array",
"description":"List of visits for eligibility.",
"items":{
"$ref":"#/components/schemas/VisitsDTO1"
}
}
},
"description":"DTO containing list of visits for bulk sign eligibility request."
},
"SignInfoRequestDTO":{
"type":"object",
"properties":{
"signInfoRequest":{
"$ref":"#/components/schemas/SignInfoDTO"
}
},
"description":"Request body DTO for retrieving sign eligibility details for multiple subjects and visits."
},
"DataElementDto13":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"sourceTimeStamp":{
"type":"string",
"description":"Source timestamp for this data element version.",
"format":"date-time",
"example":"2024-03-15T10:22:11Z"
}
},
"description":"Represents a data element that is eligible for the clear data operation at the requested scope"
},
"ClearDataCheckRequestDto":{
"required":[
"eventId",
"studyVersion",
"subjectId"
],
"type":"object",
"properties":{
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF12ABCDEF12ABCDEF12ABCDEF12"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"F1C29B36F5D64B1B95F4BDBBCEA41234"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"A1C29B36F5D64B1B95F4BDBBCEA4FF11"
},
"repeatSectionFormNumber":{
"type":"integer",
"description":"Repeat section form number, if applicable.",
"format":"int64",
"example":1
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":3
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"C1C29B36F5D64B1B95F4BDBBCEA48EEE"
}
},
"description":"For checking eligibility to clear data for a set of data elements.",
"example":{
"studyVersion":"2.0.0.38",
"subjectId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"eventId":"ABCDEF12ABCDEF12ABCDEF12ABCDEF12",
"eventInstanceNum":2,
"formId":"F1C29B36F5D64B1B95F4BDBBCEA41234",
"formSectionId":"A1C29B36F5D64B1B95F4BDBBCEA4FF11",
"repeatSectionFormNumber":1,
"repeatSequenceNumber":3,
"itemId":"C1C29B36F5D64B1B95F4BDBBCEA48EEE"
}
},
"SignVerifyFreezeDTOv20":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the Sign/Verify/Freeze record in UUID format",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-02T17:30:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2C3F40649C654D0F995A7FDBBCEA4FAB"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":100
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"reason to make this change",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments if provided",
"example":"Data discrepancy observed and clarified"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"C39E34A9152148E0BB831239BAA3E502"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"signed":{
"type":"string",
"description":"Signed status can be of SIGNED, UNSIGNED, NEVER_SIGNED, PARTIAL_SIGNED ",
"example":"2C3F40649C654D0F995A7FDBBCEA4FAB"
},
"verify":{
"type":"string",
"description":"Verify status can be UNVERIFIED, VERIFIED, NEVER_VERIFIED, VERIFY_REQUIRED",
"example":"VERIFIED"
},
"freeze":{
"type":"string",
"description":"Freeze status can be of FROZEN, UNFROZEN, NEVER_FROZEN",
"example":"FROZEN"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
}
},
"description":"DTO representing signature and freeze information for a data element in a study."
},
"SdvItemSelectionResponse":{
"type":"object",
"properties":{
"sdvSelectionNatureEnum":{
"type":"string",
"description":"Nature of SDV selection for the item result may containg OPTIONAL_CRITICAL, IRRELEVANT, OLD,OBLIGATORY, OPTIONAL, IRRELEVANT_OLD.",
"example":"OPTIONAL_CRITICAL"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
}
},
"description":"DTO representing selected SDV items for subject/event/form context."
},
"UnsignUnverifyResponse":{
"type":"object",
"properties":{
"subjects":{
"type":"string",
"description":"List of Unique Identifier(UUID, 32-character uppercase hexadecimal string) representing Subjects.",
"format":"UUID",
"example":"[\"2C3F40649C654D0F995A7FDBBCEA4FAB\"]"
}
}
},
"UnsignUnverifyRequest":{
"required":[
"subjects"
],
"type":"object",
"properties":{
"subjects":{
"uniqueItems":true,
"type":"array",
"description":"List of Unique Identifier(UUID, 32-character uppercase hexadecimal string) representing Subjects.",
"example":[
"6D5E607D3E644F1DB8FFC4BCCEA48FFE",
"2A2E107D3E644F1DB8FFC4BCCEA48ABC"
],
"items":{
"type":"string",
"description":"List of Unique Identifier(UUID, 32-character uppercase hexadecimal string) representing Subjects.",
"format":"uuid"
}
},
"reason":{
"type":"string",
"description":"Reason for the unsign/unverify action.",
"example":"Audit requirement for unsigning"
},
"comment":{
"type":"string",
"description":"Additional comments for the operation.",
"example":"Investigator request for subject data change"
}
},
"description":"DTO to request the unsign and/or unverify operations on one or more subjects.",
"example":{
"subjects":[
"6D5E607D3E644F1DB8FFC4BCCEA48FFE",
"2A2E107D3E644F1DB8FFC4BCCEA48ABC"
],
"reason":"Audit requirement for unsigning",
"comment":"Investigator request for subject data change"
}
},
"SignConfiguration":{
"required":[
"configName",
"requiredOn",
"targetSet"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the persisted signature configuration.",
"format":"UUID",
"example":"11223344556677889900AABBCCDDEEFF"
},
"configName":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Name/title for the signature configuration.",
"example":"Archive Visit Config"
},
"requiredOn":{
"maxLength":16,
"minLength":0,
"type":"string",
"description":"Level at which signature is required.",
"example":"FORM",
"enum":[
"CASEBOOK",
"VISIT",
"FORM"
]
},
"affidavitCodeValue":{
"type":"string",
"description":"Affidavit code value associated with the signature requirement.",
"example":"Electronic Signature Affidavit"
},
"requiredBy":{
"type":"string",
"description":"Delimited UUID string indicating users required to sign in (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"99887766554433221100AABBCCDDEEFF"
},
"targetSet":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Indicator if a target date/condition is set (Y or N).",
"example":"Y"
},
"targetDate":{
"type":"integer",
"description":"Target date for signature as integer.",
"format":"int64",
"example":3
},
"targetAfter":{
"type":"string",
"description":"Event or milestone after which target is to be achieved. values can be start, completion.",
"example":"start"
},
"emailReminder":{
"type":"string",
"description":"Indicates if email reminders are active ('Y' or 'N').",
"example":"Y"
},
"requiredOnForms":{
"type":"string",
"description":"Delimited string of form UUIDs to which config applies.",
"example":"AABBCCDD11223344556677889900EEFF"
},
"requiredOnVisits":{
"type":"string",
"description":"Delimited string of visit UUIDs (UUID, 32-character uppercase hexadecimal string) to which config applies.",
"format":"UUID",
"example":"FFEEDDCCBBAA99887766554433221100"
},
"triggerQuestion":{
"type":"string",
"description":"UUID (UUID, 32-character uppercase hexadecimal string) of the trigger question for conditional rules.",
"format":"UUID",
"example":"55AA44BB33CC22DD11EEFF0011223344"
},
"triggerAnswer":{
"type":"string",
"description":"String or delimited string of answers that act as trigger.",
"example":"No"
}
},
"description":"Entity model representing persisted signature configuration in the database. Properties include forms/visits, settings, lifecycle, and audit info."
},
"SignatureConfigurationDTO":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the signature configuration in UUID format.",
"format":"UUID",
"example":"AABBCCDDEEFF00112233445566778899"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T00:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-12-31T23:59:59Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"User ID(UUID, 32-character uppercase hexadecimal string) that performed the operation in UUID format.",
"example":"00112233445566778899AABBCCDDEEFF"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"format":"int32",
"example":1
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the configuration or operation.",
"example":"Other."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments about this signature configuration.",
"example":"Added new signature step for visit."
},
"configName":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"A user-friendly name for the signature configuration, used to distinguish it from other configurations.",
"example":"Final Visit Sign Config"
},
"requiredOn":{
"maxLength":16,
"minLength":0,
"type":"string",
"description":"Level at which signature is required.",
"example":"FORM",
"enum":[
"CASEBOOK",
"VISIT",
"FORM"
]
},
"affidavitCodeValue":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Affidavit code for the configuration.",
"example":"Electronic Signature Affidavit"
},
"requiredBy":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"List of user IDs (UUID, 32-character uppercase hexadecimal string) required to sign.",
"example":[
"DDEEFF00112233445566778899AABBCC"
],
"items":{
"type":"string",
"description":"List of user IDs (UUID, 32-character uppercase hexadecimal string) required to sign.",
"format":"uuid"
}
},
"targetSet":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Indicator if target is set ('Y' or 'N').",
"example":"Y"
},
"targetDate":{
"type":"integer",
"description":"Target date for signature as integer.",
"format":"int64",
"example":2
},
"targetAfter":{
"maxLength":16,
"minLength":0,
"type":"string",
"description":"Event after which the target is considered achieved.",
"example":"COMPLETION",
"enum":[
"COMPLETION",
"START"
]
},
"emailReminder":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Indicator to send email reminder ('Y' or 'N').",
"example":"N"
},
"requiredOnForms":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"List of form IDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"format":"UUID",
"example":[
"A1B2C3D4E5F607182736454647484950"
],
"items":{
"type":"string",
"description":"List of form IDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"format":"uuid"
}
},
"requiredOnVisits":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"List of visit IDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"format":"UUID",
"example":[
"5A6B7C8D9E0F10293847560123456789"
],
"items":{
"type":"string",
"description":"List of visit IDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"format":"uuid"
}
},
"triggerQuestion":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the trigger question for conditional rules.",
"example":"55AA44BB33CC22DD11EEFF0011223344"
}
},
"description":"Represents the configuration for electronic signatures for a study, including the required forms, visits, users, and rules."
},
"RestResponseListSignatureConfigurationDTO":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SignatureConfigurationDTO"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"RestResponseSignatureConfigurationDTO":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SignatureConfigurationDTO"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SignatureConfigurationReqDto":{
"type":"object",
"properties":{
"configName":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Name of the signature configuration.",
"example":"Final Visit Sign Config"
},
"requiredOn":{
"maxLength":16,
"minLength":0,
"type":"string",
"description":"Level at which signature is required.",
"example":"FORM",
"enum":[
"CASEBOOK",
"VISIT",
"FORM"
]
},
"affidavitCodeValue":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Affidavit code associated with this configuration.",
"example":"Electronic Signature Affidavit"
},
"requiredBy":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"List of user IDs(UUID, 32-character uppercase hexadecimal string) who are required to sign.",
"example":[
"DDEEFF00112233445566778899AABBCC"
],
"items":{
"type":"string",
"description":"List of user IDs(UUID, 32-character uppercase hexadecimal string) who are required to sign.",
"format":"uuid"
}
},
"targetSet":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Indicator if a target is set ('Y' or 'N').",
"example":"Y"
},
"targetDate":{
"type":"integer",
"description":"Target date for signature as integer.",
"format":"int64",
"example":3
},
"targetAfter":{
"maxLength":16,
"minLength":0,
"type":"string",
"description":"Event after which the target is achieved.",
"example":"COMPLETION",
"enum":[
"COMPLETION",
"START"
]
},
"emailReminder":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Indicator for sending email reminders ('Y' or 'N').",
"example":"N"
},
"requiredOnForms":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"List of form UUIDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"example":[
"A1B2C3D4E5F607182736454647484950"
],
"items":{
"type":"string",
"description":"List of form UUIDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"format":"uuid"
}
},
"requiredOnVisits":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"List of visit UUIDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"example":[
"5A6B7C8D9E0F10293847560123456789"
],
"items":{
"type":"string",
"description":"List of visit UUIDs(UUID, 32-character uppercase hexadecimal string) required to sign.",
"format":"uuid"
}
},
"triggerQuestion":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the trigger question for conditional signatures.",
"example":"66778899AABBCCDDEEFF001122334455"
},
"triggerAnswer":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"List of trigger answers used for conditional signatures.",
"example":[
"Yes"
],
"items":{
"type":"string",
"description":"List of trigger answers used for conditional signatures.",
"example":"[\"Yes\"]"
}
}
},
"description":"Request payload for saving a new signature configuration. Specifies forms, visits, users, triggers, and other settings for electronic signatures."
},
"SignatureConfigurationRequestDTO":{
"type":"object",
"properties":{
"signConfiguration":{
"$ref":"#/components/schemas/SignatureConfigurationDTO"
}
},
"description":"Request payload for updating an existing signature configuration. Contains a single SignatureConfigurationDTO object representing all configuration properties to update."
},
"SignEligibilitySummaryResponse":{
"type":"object",
"properties":{
"due":{
"type":"integer",
"description":"Number of signature evaluations that are due.",
"format":"int64",
"example":10
},
"overdue":{
"type":"integer",
"description":"Number of overdue signature evaluations.",
"format":"int64",
"example":5
}
},
"description":"Object representing summary of signature eligibility, including number of due and overdue items."
},
"ClearDataCheckResponse":{
"type":"object",
"properties":{
"itemEligible":{
"type":"boolean",
"description":"Whether the item is eligible for data clearance.",
"example":true
},
"validationAt":{
"type":"string",
"description":"Validation context or hierarchy where checked, for example ITEM, SUBJECT, VISIT.",
"example":"SUBJECT"
},
"itemEmpty":{
"type":"boolean",
"description":"Whether item is currently empty.",
"example":false
},
"itemReadOnly":{
"type":"boolean",
"description":"Is the item currently read-only?",
"example":false
},
"itemHidden":{
"type":"boolean",
"description":"Whether the item is hidden in the UI.",
"example":false
},
"itemLocked":{
"type":"boolean",
"description":"Whether the item is currently locked.",
"example":false
},
"itemFrozen":{
"type":"boolean",
"description":"Whether the item is frozen (cannot be changed).",
"example":false
},
"itemUnFrozen":{
"type":"boolean",
"description":"Whether the item was unfrozen since initial freeze.",
"example":true
},
"itemInfo":{
"$ref":"#/components/schemas/ItemInfo"
},
"childHidden":{
"type":"boolean",
"description":"Indicates if any child item is hidden.",
"example":false
},
"childReadOnly":{
"type":"boolean",
"description":"Indicates if any child item is read-only.",
"example":false
},
"childLocked":{
"type":"boolean",
"description":"Indicates if any child item is locked.",
"example":false
},
"childFrozen":{
"type":"boolean",
"description":"Indicates if any child item is frozen.",
"example":false
},
"childUnFrozen":{
"type":"boolean",
"description":"Indicates if a child was unfrozen.",
"example":true
},
"childInFutureVisit":{
"type":"boolean",
"description":"Whether any child is part of a visit not yet occurred.",
"example":false
},
"childInFutureForm":{
"type":"boolean",
"description":"Whether any child is part of a form not yet active.",
"example":false
},
"childVisits":{
"type":"array",
"description":"List of info for each child visit object.",
"items":{
"$ref":"#/components/schemas/ItemInfo"
}
},
"childForms":{
"type":"array",
"description":"List of info for each child form object.",
"items":{
"$ref":"#/components/schemas/ItemInfo"
}
},
"childSections":{
"type":"array",
"description":"List of info for child sections (if any).",
"items":{
"$ref":"#/components/schemas/ItemInfo"
}
},
"childQuestions":{
"type":"array",
"description":"List of info for any child question items.",
"items":{
"$ref":"#/components/schemas/ItemInfo"
}
},
"grandParent":{
"type":"boolean",
"description":"Whether this parent item is a grandparent in the hierarchy.",
"example":false
},
"formAssociated":{
"type":"boolean",
"description":"Whether the item is associated to a form.",
"example":true
}
},
"description":"Response to clear data eligibility check request, containing eligibility status and detailed item/child/descendant info."
},
"ItemInfo":{
"type":"object",
"properties":{
"type":{
"type":"string",
"description":"Type of the child object: VISIT, FORM, SECTION, or QUESTION.",
"example":"VISIT"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"formName":{
"type":"string",
"description":"Name of the form.",
"example":"Physical Exam"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"itemName":{
"type":"string",
"description":"Name of the child item or question.",
"example":"Is patient fasting?"
}
},
"description":"List of info for any child question items."
},
"ClearDataCheckRequestDto2":{
"required":[
"eventId",
"studyVersion",
"subjectId"
],
"type":"object",
"properties":{
"value":{
"maxItems":4000,
"minItems":0,
"type":"array",
"description":"A list of values to check for eligibility to clear.",
"example":[
"PASS",
"MISSING"
],
"items":{
"type":"string",
"description":"A list of values to check for eligibility to clear.",
"example":"[\"PASS\",\"MISSING\"]"
}
},
"scope":{
"type":"string",
"description":"scope type can ITEM/VSD",
"example":"ITEM"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF12ABCDEF12ABCDEF12ABCDEF12"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"F1C29B36F5D64B1B95F4BDBBCEA41234"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"A1C29B36F5D64B1B95F4BDBBCEA4FF11"
},
"repeatSectionFormNumber":{
"type":"integer",
"description":"Repeat section form number, if applicable.",
"format":"int64",
"example":1
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":3
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"C1C29B36F5D64B1B95F4BDBBCEA48EEE"
}
},
"description":"DTO for checking eligibility to clear data for a set of data elements.",
"example":"{\n \"studyVersion\": \"2.0.0.38\",\n \"subjectId\": \"1BC29B36F5D64B1B95F4BDBBCEA481BE\",\n \"eventId\": \"ABCDEF12ABCDEF12ABCDEF12ABCDEF12\",\n \"eventInstanceNum\": 2,\n \"formId\": \"F1C29B36F5D64B1B95F4BDBBCEA41234\",\n \"formSectionId\": \"A1C29B36F5D64B1B95F4BDBBCEA4FF11\",\n \"repeatSectionFormNumber\": 1,\n \"repeatSequenceNumber\": 3,\n \"itemId\": \"C1C29B36F5D64B1B95F4BDBBCEA48EEE\",\n \"value\": \"[ \"PASS\", \"MISSING\" ]\",\n \"scope\": \"ITEM\"\n}"
},
"UnSignUnVerifyRequestDto":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"reason":{
"type":"string",
"description":"Reason for the operation, if supplied. Accepted values are Change for encoding, Incorrect Subject, Investigator Correction, Transcription Error, Other.",
"example":"Other"
},
"comment":{
"type":"string",
"description":"Any extra comment for the action when Other is selected in reason.",
"example":"The data required is missing."
},
"elements":{
"type":"array",
"description":"List of core sign/verify target elements.",
"items":{
"$ref":"#/components/schemas/CoreSignVerifyRequestDto"
}
},
"unverifyVisitStartDate":{
"type":"boolean",
"description":"Parameter to determine whether we should unverify visit date. Allowed values: true/false",
"example":true
},
"unsignVisitStartDate":{
"type":"boolean",
"description":"Parameter to determine whether we should unverify visit date. Allowed values: true/false",
"example":false
},
"clearVisitStartDate":{
"type":"boolean",
"description":"Parameter to determine whether we should unverify/unsign visit date as clear operation. Allowed values: true/false",
"example":true
}
},
"xml":{
"name":"signVerifyRequest"
}
},
"DataActionsDTO2":{
"type":"object",
"properties":{
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"8877665544332211AABBCCDDEEFF0011"
},
"id":{
"type":"string",
"description":"Unique identifier for a data action given in UUID, 32-character uppercase hexadecimal string format.",
"example":"A1B23C45D67E89F123456789ABCDEF12"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T00:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-12-31T23:59:59Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"E1F2D3C4B5A697887766554433221100"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"format":"integer",
"example":2
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"format":"integer",
"example":3
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the data action.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments about the action.",
"example":"Lock applied due to protocol deviation"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"C9F84A1D5C7E42A8B9F56321A4B8D721"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"3EFD49D47C96428C9AAE2FDDE2A32D23"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"A1B23C45D67E89F123456789ABCDEF12"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":2
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"ABCDEFABCDEF1234567890ABCDEF1234"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Form repeat number if applicable.",
"format":"int64",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"action":{
"type":"string",
"description":"Action taken on the visit start date value.Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateAction":{
"type":"string",
"description":"Action performed on visit start date LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"UNLOCKED"
},
"subjectLockStatus":{
"type":"string",
"description":"Lock status of the subject for the action, can be of LOCKED, UNLOCKED.",
"example":"LOCKED"
}
},
"description":"DTO representing details of a data action in API v3, including lock status at subject level."
},
"RestResponseListDataActionsDTO2":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataActionsDTO2"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"FormItemSummaryDtoV1":{
"title":"FormItemSummaryDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Item Unique GUID",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form item reference name.",
"example":"NUMBER_01"
},
"questionType":{
"title":"FormItemType",
"type":"string",
"description":"Question type",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"questionLabel":{
"type":"string",
"description":"Form question label",
"example":"Age"
},
"subItemIds":{
"title":"Sub item ids",
"type":"string",
"description":"List of sub question ids",
"format":"uuid"
}
},
"description":"Reduced form item properties"
},
"FormSummaryDTOV1":{
"title":"FormSummaryDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"title":{
"type":"string",
"description":"Form title",
"example":"Demography"
},
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemSummaryDtoV1"
}
}
},
"description":"Reduced form properties"
},
"FileUploadRequest":{
"required":[
"fileName",
"mode",
"name"
],
"type":"object",
"properties":{
"name":{
"type":"string",
"description":"Random name for bucket where file uploaded",
"example":"1A73BC4FE4954AE4AC50DDF9729F80BE"
},
"mode":{
"type":"string",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"example":"test, active, or training"
},
"fileName":{
"type":"string",
"description":"File name",
"example":"File1001"
},
"contentType":{
"type":"string",
"description":"File content type.",
"example":"image/png"
}
},
"description":"Logo upload request details.",
"example":{
"name":"1A73BC4FE4954AE4AC50DDF9729F80BE",
"mode":"design",
"fileName":"study-logo.png",
"contentType":"image/png"
}
},
"FormChoiceItemDtov17":{
"title":"FormChoiceItemDto v17.0",
"required":[
"display",
"options",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Choice Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
},
{
"type":"object",
"properties":{
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov17"
}
},
"display":{
"pattern":"selectbox|checkbox|radioset|label",
"type":"string",
"description":"Form choice item display in UI - Selectbox.",
"example":"selectbox"
},
"columnLayout":{
"type":"string",
"description":"Coumn Layout codelist ID",
"example":"EBCF17C5F8D4460AA4A9673485C79CF0"
},
"columnLayoutLabel":{
"type":"string",
"description":"Coumn Layout Label in UI",
"example":"Single"
},
"options":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDtov17"
}
},
"clTitle":{
"type":"string",
"description":"Codelist title only for choice type formitem",
"example":"Gender"
},
"clDescription":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Codelist description only for choice type formitem",
"example":"Standard gender codelist"
},
"isCodeListReplaced":{
"type":"boolean",
"description":"Indicates if the choice option codelist is replaced",
"example":true
}
}
}
]
},
"FormCopySourceDtov17":{
"title":"FormCopySourceDto v17.0",
"type":"object",
"properties":{
"FormId":{
"type":"string",
"description":"Source Form GUID",
"format":"uuid"
},
"id":{
"type":"string",
"description":"Source Study GUID",
"format":"uuid"
},
"StudyTitle":{
"type":"string",
"description":"Source Study title",
"example":"Study-s1"
},
"versionstart":{
"type":"boolean",
"description":"is Rules Copied",
"example":false
}
},
"description":"Form Copy Source Information"
},
"FormDatetimeItemDtov17":{
"title":"FormDatetimeItemDto v17.0",
"required":[
"format",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form DateTime Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
},
{
"type":"object",
"properties":{
"format":{
"type":"string",
"description":"Date time format",
"example":"DD-MON-YYYY"
},
"allowPartialDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow partial date",
"format":"int32",
"example":1
},
"partialDate":{
"type":"string",
"description":"Partial date format",
"example":"Jan-1993"
},
"allowFutureDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow future date",
"format":"int32",
"example":1
}
}
}
]
},
"FormDtoWithStudyVersion":{
"required":[
"refname",
"title"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form title",
"example":"Demography"
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"repeat":{
"type":"boolean",
"description":"Form repeating?",
"example":false
},
"source":{
"$ref":"#/components/schemas/FormCopySourceDtov19"
},
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov19"
}
},
"versionStart":{
"type":"string",
"description":"The form's version date",
"format":"date-time"
},
"allowMultipleInstances":{
"type":"boolean",
"description":"Allow multiple instances",
"example":true
},
"dynamic":{
"type":"integer",
"description":"Count of forms items that point to this form for Show Form feature",
"format":"int32",
"example":4
},
"formType":{
"type":"string",
"description":"Form type",
"example":"STANDARD_FORM",
"enum":[
"STANDARD_FORM",
"LAB_FORM",
"TWO_SECTION_FORM",
"DRUG_RECONCILIATION_FORM",
"STANDARD_FORM, LAB_FORM, TWO_SECTION_FORM"
]
},
"hasRevision":{
"type":"boolean",
"description":"Indicate whether any revisions from a newer study version have been applied",
"example":true
},
"linkFrom":{
"type":"array",
"description":"linked from forms",
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov19"
}
},
"showFrom":{
"type":"array",
"description":"show dynamic parent from forms of same visit",
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov19"
}
},
"assignedVisits":{
"type":"array",
"description":"branch cycle information describing the visits on which the forms are displayed",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov19"
}
},
"includeInSafetyCaseData":{
"type":"boolean",
"description":"Is form associated to Safety Case Forms",
"example":true
},
"formCategory":{
"type":"string",
"description":"Form category",
"example":"DCS"
},
"formSubcategory":{
"type":"array",
"description":"Form subcategory list",
"items":{
"type":"string",
"description":"Form subcategory list"
}
},
"logoFileName":{
"type":"string",
"description":"Logo File Name"
},
"logoFileUploadRequest":{
"$ref":"#/components/schemas/FileUploadRequest"
},
"studyVersion":{
"type":"string",
"description":"Study version of the study in which form belongs",
"example":"1.0.0.1"
},
"baseStudyVersion":{
"type":"string",
"description":"Base Study version of the study from which the form is requested.",
"example":"1.0.0.1"
}
}
},
"FormExistingDataItemDtoV17":{
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form existing data item Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
},
{
"type":"object",
"properties":{
"codeName":{
"type":"string",
"description":"Codelist name for existing data, must be a value from ExistingDataLabels codelist",
"example":"EDLSite"
},
"codeValue":{
"type":"string",
"description":"Codelist value specifying existing data, must be a value from codelist defined in codeName",
"example":"SiteName"
}
}
}
]
},
"FormInstructionalTextItemDtov17":{
"title":"FormInstructionalTextItem v17.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Instructional information about the form or question",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
},
{
"type":"object",
"properties":{
"instructionalText":{
"type":"string",
"description":"Instructional information about the form or question",
"example":"Complete all parts of the form"
}
}
}
]
},
"FormItemAdvancedPropDtov17":{
"title":"From Item Advanced Property v17.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov17"
}
}
},
"description":"Form Item Advanced Property"
},
"FormItemAdvancedPropRuleDtov17":{
"title":"From Item Advanced Property Rule v17.0",
"type":"object",
"properties":{
"name":{
"type":"string",
"description":"name",
"example":"RolloverQuestionAnswer"
},
"value":{
"type":"string",
"description":"For RolloverQuestion property it is an ECDV_CODELISTITEM.CODELISTITEM_ID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"For RolloverQuestion property it is an ECDV_CODELISTITEM.VALUE",
"example":"Yes"
}
},
"description":"Form Item Advanced Property Rule"
},
"FormItemAdvancedPropWithParentDtov17":{
"title":"From Item Advanced Property With Parent v17.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"parent object ID",
"format":"uuid"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov17"
}
},
"parentObjectLabel":{
"type":"string",
"description":"parent object name",
"example":"Form 1"
},
"parentObjectLevel":{
"type":"string",
"description":"type of parent object",
"example":"FORM"
}
},
"description":"Form Item Advanced Property with Parent Info"
},
"FormItemDtov17":{
"title":"FormItemDto v17.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"properties":{
"questionType":{
"title":"FormItemType",
"type":"string",
"description":"Question type",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"id":{
"type":"string",
"description":"Form Item Unique GUID",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formTitle":{
"type":"string",
"description":"Form title",
"example":"Demography"
},
"questionLabel":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form question label",
"example":"Age"
},
"questionHint":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Form question hint",
"example":"What is your age?"
},
"randomizationTag":{
"type":"boolean",
"description":"Flag that indicates whether this form item should be used for randomization stratification or not.",
"example":true
},
"isStrataFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization stratum or not.",
"example":false
},
"isCohortFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization cohort or not.",
"example":false
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form item reference name.",
"example":"NUMBER_01"
},
"applyChangeToVersion":{
"type":"string",
"description":"For IPR apply change to version",
"example":"1.0.0.1"
},
"required":{
"type":"boolean",
"description":"Whether this form item is requiered or not.",
"example":true
},
"dynamic":{
"type":"integer",
"description":"How many leading questions in this form have to be answered by user correctly before Item is included into the form.",
"format":"int32",
"example":1
},
"hidden":{
"type":"boolean",
"description":"Is form item hidden?",
"example":false
},
"readOnly":{
"type":"boolean",
"description":"Is form item read only?",
"example":false
},
"ruleSet":{
"type":"string",
"description":"A JSON-formatted set of rules to do validation of the answers.",
"example":"{'logicalOperator':'NONE','rules':[],'numberIndex':1}"
},
"sdvRequired":{
"type":"string",
"description":"Source Data Verification Type",
"example":"NEVER(0),ALWAYS(1),CRITICAL(2)",
"enum":[
"NOTSET",
"NEVER",
"ALWAYS",
"CRITICAL"
]
},
"sequence":{
"type":"integer",
"description":"Item position in the form.",
"format":"int32",
"example":1
},
"groupSequence":{
"type":"integer",
"description":"Group sequence.",
"format":"int32"
},
"smartItemId":{
"type":"string",
"description":"Smart item Unique GUID",
"format":"uuid"
},
"formula":{
"type":"string",
"description":"Smart item formula.",
"example":"[{'ruleName':'AGE','ruleExpression':'AgeInYears(AGE_DOB_01, visitDate)'}]"
},
"smartObject":{
"type":"string",
"description":"Smart object.",
"example":"AGE"
},
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov17"
}
},
"sasVariable":{
"type":"string",
"description":"Form Item SASVariable",
"example":"AE"
},
"sasLabel":{
"type":"string",
"description":"Form Item sasLabel",
"example":"Adverse Event"
},
"labNormalsTag":{
"type":"string",
"description":"Lab Normals Tag used in dialog tagging",
"example":"LabTest, LabUnit, LabLowRange, LabHighRange, LabStandardResult"
},
"clLabNormalsTag":{
"type":"string",
"description":"Code list Lab Normals Tag used in the code list dialog tagging",
"example":"LabTest, LabUnit, LabGender, LabRace, LabStandardResult"
},
"dataClassificationIds":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov17"
}
},
"dataClassificationLevel":{
"type":"string",
"description":"Data classification level if applicable",
"example":"edit, view"
}
},
"description":"Form Item Information",
"discriminator":{
"propertyName":"questionType",
"mapping":{
"datetime":"#/components/schemas/FormDatetimeItemDtov17",
"numeric":"#/components/schemas/FormNumberItemDtov17",
"measurement":"#/components/schemas/FormNumberItemDtov17",
"text":"#/components/schemas/FormTextItemDtov17",
"choice":"#/components/schemas/FormChoiceItemDtov17",
"questionGroup":"#/components/schemas/FormQuestionGroupItemDtov17",
"table":"#/components/schemas/FormTableItemDtov17",
"section":"#/components/schemas/FormSectionalItemDtov17",
"label":"#/components/schemas/FormInstructionalTextItemDtov17",
"existingData":"#/components/schemas/FormExistingDataItemDtoV17"
}
},
"oneOf":[
{
"$ref":"#/components/schemas/FormNumberItemDtov17"
},
{
"$ref":"#/components/schemas/FormChoiceItemDtov17"
},
{
"$ref":"#/components/schemas/FormTextItemDtov17"
},
{
"$ref":"#/components/schemas/FormDatetimeItemDtov17"
},
{
"$ref":"#/components/schemas/FormQuestionGroupItemDtov17"
},
{
"$ref":"#/components/schemas/FormTableItemDtov17"
},
{
"$ref":"#/components/schemas/FormSectionalItemDtov17"
},
{
"$ref":"#/components/schemas/FormLabelItemDto"
},
{
"$ref":"#/components/schemas/FormInstructionalTextItemDtov17"
},
{
"$ref":"#/components/schemas/FormExistingDataItemDtoV17"
}
]
},
"FormLabelItemDto":{
"required":[
"display",
"options",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov21"
}
},
"display":{
"pattern":"selectbox|checkbox|radioset|label",
"type":"string",
"description":"Form choice item display in UI - Selectbox.",
"example":"selectbox"
},
"columnLayout":{
"type":"string",
"description":"Coumn Layout codelist ID",
"example":"EBCF17C5F8D4460AA4A9673485C79CF0"
},
"columnLayoutLabel":{
"type":"string",
"description":"Coumn Layout Label in UI",
"example":"Single"
},
"options":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDtov21"
}
},
"clTitle":{
"type":"string",
"description":"Codelist title only for choice type formitem",
"example":"Gender"
},
"clDescription":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Codelist description only for choice type formitem",
"example":"Standard gender codelist"
},
"isCodeListReplaced":{
"type":"boolean",
"description":"Indicates if the choice option codelist is replaced",
"example":true
},
"codelistType":{
"type":"string",
"description":"Form items field to indicate dynamic or static variant of the codelist mapped to item. ",
"enum":[
"STATIC, DYNAMIC"
]
},
"codelistId":{
"type":"string",
"description":"ID of the codelist used in the question ",
"format":"uuid"
},
"codelistLang":{
"type":"string",
"description":"Language of the codelist used in the question ",
"example":"en-US"
}
}
}
]
},
"FormLinkFromDtov17":{
"title":"FormLinkFromDto v17.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"items":{
"type":"array",
"description":"Form items",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov17"
}
},
"parentAssignedVisits":{
"type":"array",
"description":"Parent Assigned Visits",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov17"
}
}
},
"description":"Linked From Form Details"
},
"FormNumberItemDtov17":{
"title":"FormNumberItemDto v17.0",
"required":[
"precision",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Number Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
},
{
"type":"object",
"properties":{
"precision":{
"minimum":0,
"type":"integer",
"description":"Number value precision",
"format":"int32",
"example":1
},
"units":{
"type":"string",
"description":"Units of measure",
"example":"kg"
}
}
}
]
},
"FormOptionDtov17":{
"title":"FormOptionDto v17.0",
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox label for a one specific choice.",
"example":"Female"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox value for a one specific choice.",
"example":"1"
},
"clCode":{
"type":"string",
"description":"Codelist code for a one specific choice.",
"example":"1"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description for a one specific choice.",
"example":"1"
},
"clValue":{
"type":"string",
"description":"Codelist value for a one specific choice.",
"example":"1"
}
},
"description":"Form choice item option details"
},
"FormQuestionGroupItemDtov17":{
"title":"FormQuestionGroupItemDto v17.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Question Group Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
}
]
},
"FormSectionalItemDtov17":{
"title":"FormSectionalItemDto v17.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Section Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
}
]
},
"FormTableItemDtov17":{
"title":"FormTableItemDto v17.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form table Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
},
{
"type":"object",
"properties":{
"allowAdditionalRows":{
"type":"boolean"
}
}
}
]
},
"FormTextItemDtov17":{
"title":"FormTextItemDto v17.0",
"required":[
"maxlength",
"multiline",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form text Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov17"
},
{
"type":"object",
"properties":{
"maxlength":{
"maximum":4000,
"minimum":0,
"type":"integer",
"description":"Form text item max length",
"format":"int32",
"example":4000
},
"multiline":{
"type":"boolean",
"description":"Is form text item multiline",
"example":false
}
}
}
]
},
"E2BR3ItemAdvancedPropDtov1":{
"title":"E2BR3ItemAdvancedPropDto v1.0",
"type":"object",
"properties":{
"mandatory":{
"type":"boolean"
},
"order":{
"type":"string"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/E2BR3ItemAdvancedPropDtov1"
}
},
"id":{
"type":"string",
"description":"Advanced property id",
"format":"uuid"
},
"type":{
"type":"string",
"description":"Advanced property type, mapped to the ECD_EXTENDED_PROPERTIES.RESPONSE_MAP_JSON column 'valueType' field",
"example":"Dropdown"
},
"name":{
"type":"string",
"description":"Advanced property name, mapped to the ECD_EXTENDED_PROPERTIES.PROPERTY_NAME column",
"example":"RolloverQuestion"
},
"value":{
"type":"string",
"description":"Advanced property value of studyId",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Advanced property label in UI, i.e. studyName",
"example":"Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtoV7"
}
},
"parentObjectId":{
"type":"string",
"format":"uuid"
},
"parentObjectLevel":{
"type":"string"
},
"parentObjectLabel":{
"type":"string"
}
},
"description":"E2B3 Mapping Details Information"
},
"FormItemAdvancedPropRuleDtoV7":{
"title":"From Item Advanced Property Rule v7.0",
"type":"object",
"properties":{
"name":{
"type":"string",
"description":"name",
"example":"Answer for Rollover"
},
"value":{
"type":"string",
"description":"For RolloverQuestion property it is an ECD_CODELISTITEM.CODELISTITEM_ID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"For RolloverQuestion property it is an ECD_CODELISTITEM.OBJECT_DESCRIPTION",
"example":"Yes"
}
},
"description":"Form Item Advanced Property Rule"
},
"EHRCategoryItemDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"categoryId":{
"type":"string",
"format":"uuid"
},
"categoryCode":{
"type":"string"
},
"categoryLabel":{
"type":"string"
},
"code":{
"type":"string"
},
"label":{
"type":"string"
},
"clCodeName":{
"type":"string"
},
"clCodeLabel":{
"type":"string"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/EHRCategoryItemDto"
}
},
"attributes":{
"type":"array",
"items":{
"$ref":"#/components/schemas/EHRCategoryItemDto"
}
}
}
},
"LabNormalFormDtoV1":{
"title":"LabNormalFormDto v1.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"items":{
"title":"LabNormalItemDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Item Id",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"format":{
"type":"string",
"description":"Date Format",
"example":"dd-MMM-yyyy"
},
"labNormalsTag":{
"type":"string",
"description":"labNormalsTag",
"example":"Race"
},
"options":{
"title":"FormOptionDto v17.0",
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox label for a one specific choice.",
"example":"Female"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox value for a one specific choice.",
"example":"1"
},
"clCode":{
"type":"string",
"description":"Codelist code for a one specific choice.",
"example":"1"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description for a one specific choice.",
"example":"1"
},
"clValue":{
"type":"string",
"description":"Codelist value for a one specific choice.",
"example":"1"
}
},
"description":"Form choice item option details"
}
},
"description":"Item tagged with labNormalTag Details"
}
},
"description":"LabNormal Form Detail Information"
},
"LabNormalFormItemsDtoV1":{
"title":"LabNormalFormItemsDto v1.0",
"type":"object",
"properties":{
"studyVersion":{
"type":"string",
"description":"Study Version",
"example":"1.0.0.1"
},
"forms":{
"title":"LabNormalFormDto v1.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"items":{
"title":"LabNormalItemDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Item Id",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"format":{
"type":"string",
"description":"Date Format",
"example":"dd-MMM-yyyy"
},
"labNormalsTag":{
"type":"string",
"description":"labNormalsTag",
"example":"Race"
},
"options":{
"title":"FormOptionDto v17.0",
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox label for a one specific choice.",
"example":"Female"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox value for a one specific choice.",
"example":"1"
},
"clCode":{
"type":"string",
"description":"Codelist code for a one specific choice.",
"example":"1"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description for a one specific choice.",
"example":"1"
},
"clValue":{
"type":"string",
"description":"Codelist value for a one specific choice.",
"example":"1"
}
},
"description":"Form choice item option details"
}
},
"description":"Item tagged with labNormalTag Details"
}
},
"description":"LabNormal Form Detail Information"
}
},
"description":"LabNormal Form Items Detail Information"
},
"LabNormalItemDtoV1":{
"title":"LabNormalItemDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Item Id",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"format":{
"type":"string",
"description":"Date Format",
"example":"dd-MMM-yyyy"
},
"labNormalsTag":{
"type":"string",
"description":"labNormalsTag",
"example":"Race"
},
"options":{
"title":"FormOptionDto v17.0",
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox label for a one specific choice.",
"example":"Female"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox value for a one specific choice.",
"example":"1"
},
"clCode":{
"type":"string",
"description":"Codelist code for a one specific choice.",
"example":"1"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description for a one specific choice.",
"example":"1"
},
"clValue":{
"type":"string",
"description":"Codelist value for a one specific choice.",
"example":"1"
}
},
"description":"Form choice item option details"
}
},
"description":"Item tagged with labNormalTag Details"
},
"StudyVersionFormDtoV1":{
"required":[
"formId",
"studyId",
"version"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"description":"Study GUID",
"format":"uuid"
},
"version":{
"type":"string",
"description":"version",
"example":"1.3.0.6"
},
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
}
}
},
"FormItemSummaryInfoDtov1":{
"title":"FormItemSummaryInfoDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Item UUID",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form item reference name.",
"example":"NUMBER_01"
},
"studyVersion":{
"type":"string",
"description":"Study version",
"example":"1.0.0.1"
},
"questionType":{
"title":"FormItemType",
"type":"string",
"description":"Question type",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"questionLabel":{
"type":"string",
"description":"Form question label",
"example":"Age"
},
"subItemIds":{
"title":"Sub item ids",
"type":"string",
"description":"List of sub question ids",
"format":"uuid"
},
"precision":{
"type":"integer",
"description":"Number value precision",
"format":"int32",
"example":1
},
"units":{
"type":"string",
"description":"Units of measure",
"example":"kg"
},
"readOnly":{
"type":"boolean",
"description":"Is form item read only?",
"example":false
}
},
"description":"Reduced form item properties"
},
"FormSummaryInfov1":{
"title":"FormSummaryInfoDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"title":{
"type":"string",
"description":"Form title",
"example":"Demography"
},
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemSummaryInfoDtov1"
}
}
},
"description":"Reduced form properties"
},
"FormChoiceItemDtov18":{
"title":"FormChoiceItemDto v18.0",
"required":[
"display",
"options",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Choice Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
},
{
"type":"object",
"properties":{
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov18"
}
},
"display":{
"pattern":"selectbox|checkbox|radioset|label",
"type":"string",
"description":"Form choice item display in UI - Selectbox.",
"example":"selectbox"
},
"columnLayout":{
"type":"string",
"description":"Coumn Layout codelist ID",
"example":"EBCF17C5F8D4460AA4A9673485C79CF0"
},
"columnLayoutLabel":{
"type":"string",
"description":"Coumn Layout Label in UI",
"example":"Single"
},
"options":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDtov18"
}
},
"clTitle":{
"type":"string",
"description":"Codelist title only for choice type formitem",
"example":"Gender"
},
"clDescription":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Codelist description only for choice type formitem",
"example":"Standard gender codelist"
},
"isCodeListReplaced":{
"type":"boolean",
"description":"Indicates if the choice option codelist is replaced",
"example":true
}
}
}
]
},
"FormCopySourceDtov18":{
"title":"FormCopySourceDto v18.0",
"type":"object",
"properties":{
"FormId":{
"type":"string",
"description":"Source Form GUID",
"format":"uuid"
},
"id":{
"type":"string",
"description":"Source Study GUID",
"format":"uuid"
},
"StudyTitle":{
"type":"string",
"description":"Source Study title",
"example":"Study-s1"
},
"versionstart":{
"type":"boolean",
"description":"is Rules Copied",
"example":false
}
},
"description":"Form Copy Source Information"
},
"FormDatetimeItemDtov18":{
"title":"FormDatetimeItemDto v18.0",
"required":[
"format",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form DateTime Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
},
{
"type":"object",
"properties":{
"format":{
"type":"string",
"description":"Date time format",
"example":"DD-MON-YYYY"
},
"allowPartialDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow partial date",
"format":"int32",
"example":1
},
"partialDate":{
"type":"string",
"description":"Partial date format",
"example":"Jan-1993"
},
"allowFutureDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow future date",
"format":"int32",
"example":1
}
}
}
]
},
"FormDtov18":{
"title":"FormDto v18.0",
"required":[
"refname",
"title"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form title",
"example":"Demography"
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"repeat":{
"type":"boolean",
"description":"Form repeating?",
"example":false
},
"source":{
"$ref":"#/components/schemas/FormCopySourceDtov18"
},
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov18"
}
},
"versionStart":{
"type":"string",
"description":"The form's version date",
"format":"date-time"
},
"allowMultipleInstances":{
"type":"boolean",
"description":"Allow multiple instances",
"example":true
},
"dynamic":{
"type":"integer",
"description":"Count of forms items that point to this form for Show Form feature",
"format":"int32",
"example":4
},
"formType":{
"type":"string",
"description":"Form type",
"example":"STANDARD_FORM",
"enum":[
"STANDARD_FORM",
"LAB_FORM",
"TWO_SECTION_FORM",
"DRUG_RECONCILIATION_FORM",
"STANDARD_FORM, LAB_FORM, TWO_SECTION_FORM"
]
},
"hasRevision":{
"type":"boolean",
"description":"Indicate whether any revisions from a newer study version have been applied",
"example":true
},
"linkFrom":{
"type":"array",
"description":"linked from forms",
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov18"
}
},
"showFrom":{
"type":"array",
"description":"show dynamic parent from forms of same visit",
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov18"
}
},
"assignedVisits":{
"type":"array",
"description":"branch cycle information describing the visits on which the forms are displayed",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov18"
}
},
"includeInSafetyCaseData":{
"type":"boolean",
"description":"Is form associated to Safety Case Forms",
"example":true
},
"formCategory":{
"type":"string",
"description":"Form category",
"example":"DCS"
},
"formSubcategory":{
"type":"array",
"description":"Form subcategory list",
"items":{
"type":"string",
"description":"Form subcategory list"
}
},
"logoFileName":{
"type":"string",
"description":"Logo File Name"
},
"logoFileUploadRequest":{
"$ref":"#/components/schemas/FileUploadRequest"
}
},
"description":"Form Info"
},
"FormExistingDataItemDtoV18":{
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form existing data item Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
},
{
"type":"object",
"properties":{
"codeName":{
"type":"string",
"description":"Codelist name for existing data, must be a value from ExistingDataLabels codelist",
"example":"EDLSite"
},
"codeValue":{
"type":"string",
"description":"Codelist value specifying existing data, must be a value from codelist defined in codeName",
"example":"SiteName"
}
}
}
]
},
"FormInstructionalTextItemDtov18":{
"title":"FormInstructionalTextItem v18.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Instructional information about the form or question",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
},
{
"type":"object",
"properties":{
"instructionalText":{
"type":"string",
"description":"Instructional information about the form or question",
"example":"Complete all parts of the form"
}
}
}
]
},
"FormItemAdvancedPropDtov18":{
"title":"From Item Advanced Property v18.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov18"
}
}
},
"description":"Form Item Advanced Property"
},
"FormItemAdvancedPropRuleDtov18":{
"title":"From Item Advanced Property Rule v18.0",
"type":"object",
"properties":{
"name":{
"type":"string",
"description":"name",
"example":"RolloverQuestionAnswer"
},
"value":{
"type":"string",
"description":"For RolloverQuestion property it is an ECDV_CODELISTITEM.CODELISTITEM_ID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"For RolloverQuestion property it is an ECDV_CODELISTITEM.VALUE",
"example":"Yes"
}
},
"description":"Form Item Advanced Property Rule"
},
"FormItemAdvancedPropWithParentDtov18":{
"title":"From Item Advanced Property With Parent v18.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"parent object ID",
"format":"uuid"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov18"
}
},
"parentObjectLabel":{
"type":"string",
"description":"parent object name",
"example":"Form 1"
},
"parentObjectLevel":{
"type":"string",
"description":"type of parent object",
"example":"FORM"
}
},
"description":"Form Item Advanced Property with Parent Info"
},
"FormItemDtov18":{
"title":"FormItemDto v18.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"properties":{
"questionType":{
"title":"FormItemType",
"type":"string",
"description":"Question type",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"id":{
"type":"string",
"description":"Form Item Unique GUID",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formTitle":{
"type":"string",
"description":"Form title",
"example":"Demography"
},
"questionLabel":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form question label",
"example":"Age"
},
"questionHint":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Form question hint",
"example":"What is your age?"
},
"randomizationTag":{
"type":"boolean",
"description":"Flag that indicates whether this form item should be used for randomization stratification or not.",
"example":true
},
"isStrataFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization stratum or not.",
"example":false
},
"isCohortFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization cohort or not.",
"example":false
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form item reference name.",
"example":"NUMBER_01"
},
"applyChangeToVersion":{
"type":"string",
"description":"For IPR apply change to version",
"example":"1.0.0.1"
},
"required":{
"type":"boolean",
"description":"Whether this form item is requiered or not.",
"example":true
},
"dynamic":{
"type":"integer",
"description":"How many leading questions in this form have to be answered by user correctly before Item is included into the form.",
"format":"int32",
"example":1
},
"hidden":{
"type":"boolean",
"description":"Is form item hidden?",
"example":false
},
"readOnly":{
"type":"boolean",
"description":"Is form item read only?",
"example":false
},
"ruleSet":{
"type":"string",
"description":"A JSON-formatted set of rules to do validation of the answers.",
"example":"{'logicalOperator':'NONE','rules':[],'numberIndex':1}"
},
"sdvRequired":{
"type":"string",
"description":"Source Data Verification Type",
"example":"NEVER(0),ALWAYS(1),CRITICAL(2)",
"enum":[
"NOTSET",
"NEVER",
"ALWAYS",
"CRITICAL"
]
},
"sequence":{
"type":"integer",
"description":"Item position in the form.",
"format":"int32",
"example":1
},
"groupSequence":{
"type":"integer",
"description":"Group sequence.",
"format":"int32"
},
"smartItemId":{
"type":"string",
"description":"Smart item Unique GUID",
"format":"uuid"
},
"formula":{
"type":"string",
"description":"Smart item formula.",
"example":"[{'ruleName':'AGE','ruleExpression':'AgeInYears(AGE_DOB_01, visitDate)'}]"
},
"smartObject":{
"type":"string",
"description":"Smart object.",
"example":"AGE"
},
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov18"
}
},
"sasVariable":{
"type":"string",
"description":"Form Item SASVariable",
"example":"AE"
},
"sasLabel":{
"type":"string",
"description":"Form Item sasLabel",
"example":"Adverse Event"
},
"labNormalsTag":{
"type":"string",
"description":"Lab Normals Tag used in dialog tagging",
"example":"LabTest, LabUnit, LabLowRange, LabHighRange, LabStandardResult"
},
"clLabNormalsTag":{
"type":"string",
"description":"Code list Lab Normals Tag used in the code list dialog tagging",
"example":"LabTest, LabUnit, LabGender, LabRace, LabStandardResult"
},
"dataClassificationIds":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov18"
}
},
"dataClassificationLevel":{
"type":"string",
"description":"Data classification level if applicable",
"example":"edit, view"
}
},
"description":"Form Item Information",
"discriminator":{
"propertyName":"questionType",
"mapping":{
"datetime":"#/components/schemas/FormDatetimeItemDtov18",
"numeric":"#/components/schemas/FormNumberItemDtov18",
"measurement":"#/components/schemas/FormNumberItemDtov18",
"text":"#/components/schemas/FormTextItemDtov18",
"choice":"#/components/schemas/FormChoiceItemDtov18",
"questionGroup":"#/components/schemas/FormQuestionGroupItemDtov18",
"table":"#/components/schemas/FormTableItemDtov18",
"section":"#/components/schemas/FormSectionalItemDtov18",
"label":"#/components/schemas/FormInstructionalTextItemDtov18",
"existingData":"#/components/schemas/FormExistingDataItemDtoV18"
}
},
"oneOf":[
{
"$ref":"#/components/schemas/FormNumberItemDtov18"
},
{
"$ref":"#/components/schemas/FormChoiceItemDtov18"
},
{
"$ref":"#/components/schemas/FormTextItemDtov18"
},
{
"$ref":"#/components/schemas/FormDatetimeItemDtov18"
},
{
"$ref":"#/components/schemas/FormQuestionGroupItemDtov18"
},
{
"$ref":"#/components/schemas/FormTableItemDtov18"
},
{
"$ref":"#/components/schemas/FormSectionalItemDtov18"
},
{
"$ref":"#/components/schemas/FormLabelItemDto"
},
{
"$ref":"#/components/schemas/FormInstructionalTextItemDtov18"
},
{
"$ref":"#/components/schemas/FormExistingDataItemDtoV18"
}
]
},
"FormLinkFromDtov18":{
"title":"FormLinkFromDto v18.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"items":{
"type":"array",
"description":"Form items",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov18"
}
},
"parentAssignedVisits":{
"type":"array",
"description":"Parent Assigned Visits",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov18"
}
}
},
"description":"Linked From Form Details"
},
"FormNumberItemDtov18":{
"title":"FormNumberItemDto v18.0",
"required":[
"precision",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Number Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
},
{
"type":"object",
"properties":{
"precision":{
"minimum":0,
"type":"integer",
"description":"Number value precision",
"format":"int32",
"example":1
},
"units":{
"type":"string",
"description":"Units of measure",
"example":"kg"
}
}
}
]
},
"FormOptionDtov18":{
"title":"FormOptionDto v18.0",
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox label for a one specific choice.",
"example":"Female"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox value for a one specific choice.",
"example":"1"
},
"clCode":{
"type":"string",
"description":"Codelist code for a one specific choice.",
"example":"1"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description for a one specific choice.",
"example":"1"
},
"clValue":{
"type":"string",
"description":"Codelist value for a one specific choice.",
"example":"1"
}
},
"description":"Form choice item option details"
},
"FormQuestionGroupItemDtov18":{
"title":"FormQuestionGroupItemDto v18.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Question Group Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
}
]
},
"FormSectionalItemDtov18":{
"title":"FormSectionalItemDto v18.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Section Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
}
]
},
"FormTableItemDtov18":{
"title":"FormTableItemDto v18.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form table Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
},
{
"type":"object",
"properties":{
"allowAdditionalRows":{
"type":"boolean"
}
}
}
]
},
"FormTextItemDtov18":{
"title":"FormTextItemDto v18.0",
"required":[
"maxlength",
"multiline",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form text Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov18"
},
{
"type":"object",
"properties":{
"maxlength":{
"maximum":4000,
"minimum":0,
"type":"integer",
"description":"Form text item max length",
"format":"int32",
"example":4000
},
"multiline":{
"type":"boolean",
"description":"Is form text item multiline",
"example":false
}
}
}
]
},
"StratumItemDtoV1":{
"title":"StratumItemDto v1.0",
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Stratum Item Id",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"itemRefName":{
"type":"string",
"description":"Item Ref Code",
"example":"TEXT"
},
"sasVariable":{
"type":"string",
"description":"SAS Variable",
"example":"Text"
}
},
"description":"Stratum Item Detail Information"
},
"StratumVisitDtoV1":{
"title":"StratumVisitDto v1.0",
"type":"object",
"properties":{
"visitId":{
"type":"string",
"description":"Visit Id",
"format":"uuid"
},
"items":{
"title":"StratumItemDto v1.0",
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Stratum Item Id",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"itemRefName":{
"type":"string",
"description":"Item Ref Code",
"example":"TEXT"
},
"sasVariable":{
"type":"string",
"description":"SAS Variable",
"example":"Text"
}
},
"description":"Stratum Item Detail Information"
}
},
"description":"Stratum Visit Detail Information"
},
"StratumVisitItemsDtoV1":{
"title":"StratumVisitItemsDto v1.0",
"type":"object",
"properties":{
"studyVersion":{
"type":"string",
"description":"Study Version",
"example":"1.0.0.1"
},
"strata":{
"title":"StratumVisitDto v1.0",
"type":"object",
"properties":{
"visitId":{
"type":"string",
"description":"Visit Id",
"format":"uuid"
},
"items":{
"title":"StratumItemDto v1.0",
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Stratum Item Id",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form Id",
"format":"uuid"
},
"itemRefName":{
"type":"string",
"description":"Item Ref Code",
"example":"TEXT"
},
"sasVariable":{
"type":"string",
"description":"SAS Variable",
"example":"Text"
}
},
"description":"Stratum Item Detail Information"
}
},
"description":"Stratum Visit Detail Information"
}
},
"description":"Stratum Visit Items Detail Information"
},
"StudyVersionVisitDtoV9":{
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"version":{
"type":"string",
"description":"version",
"example":"1.3.0.6"
},
"studyTitle":{
"type":"string",
"description":"Study name",
"example":"Study 03"
},
"versionStatus":{
"type":"string",
"description":"Study version status",
"example":"Active, not recruiting"
},
"versionPreviousStatus":{
"type":"string",
"description":"Previous study status",
"example":"TESTING",
"enum":[
"DRAFT",
"TESTING",
"APPROVED",
"ARCHIVED"
]
},
"visitId":{
"type":"string",
"description":"Visit GUID",
"format":"uuid"
}
}
},
"FormItemAdvancedPropDtoV7":{
"title":"From Item Advanced Property v7.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Advanced property id",
"format":"uuid"
},
"type":{
"type":"string",
"description":"Advanced property type, mapped to the ECD_EXTENDED_PROPERTIES.RESPONSE_MAP_JSON column 'valueType' field",
"example":"Dropdown"
},
"name":{
"type":"string",
"description":"Advanced property name, mapped to the ECD_EXTENDED_PROPERTIES.PROPERTY_NAME column",
"example":"RolloverQuestion"
},
"value":{
"type":"string",
"description":"Advanced property value of studyId",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Advanced property label in UI, i.e. studyName",
"example":"Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtoV7"
}
},
"parentObjectId":{
"type":"string",
"format":"uuid"
},
"parentObjectLevel":{
"type":"string"
},
"parentObjectLabel":{
"type":"string"
}
},
"description":"Form Item Advanced Property"
},
"FormItemWithActionsDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"actions":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtoV7"
}
}
}
},
"FormWithItemsActionsDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemWithActionsDto"
}
}
}
},
"StudyVisitsWithFormItemActionsDto":{
"type":"object",
"properties":{
"studyVersion":{
"type":"string"
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsWithFormItemActionsDto"
}
}
}
},
"VisitsWithFormItemActionsDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"forms":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormWithItemsActionsDto"
}
}
}
},
"FormsEhrMappingDtoV1":{
"title":"FormsEhrMappingDto v1.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"ItemsEhrMappingDto":{
"title":"ItemsEhrMappingDto v1.0",
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Item GUID",
"format":"uuid"
},
"FormItemAdvancedPropDto":{
"title":"From Item Advanced Property v17.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov17"
}
}
},
"description":"Form Item Advanced Property"
}
},
"description":"Information about EhrMappings of form item"
}
},
"description":"Information about EhrMappings of items of the form"
},
"ItemsEhrMappingDtoV1":{
"title":"ItemsEhrMappingDto v1.0",
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Item GUID",
"format":"uuid"
},
"FormItemAdvancedPropDto":{
"title":"From Item Advanced Property v17.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov17"
}
}
},
"description":"Form Item Advanced Property"
}
},
"description":"Information about EhrMappings of form item"
},
"VisitFormsEhrMappingDtoV1":{
"title":"VisitFormsEhrMappingDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Visit GUID",
"format":"uuid"
},
"FormsEhrMappingDto":{
"title":"FormsEhrMappingDto v1.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"ItemsEhrMappingDto":{
"title":"ItemsEhrMappingDto v1.0",
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Item GUID",
"format":"uuid"
},
"FormItemAdvancedPropDto":{
"title":"From Item Advanced Property v17.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov17"
}
}
},
"description":"Form Item Advanced Property"
}
},
"description":"Information about EhrMappings of form item"
}
},
"description":"Information about EhrMappings of items of the form"
}
},
"description":"Information about EhrMappings of items of the forms associated with a visit"
},
"VisitsFormsEhrMappingDtoV1":{
"title":"VisitsFormsEhrMappingDto v1.0",
"type":"object",
"properties":{
"studyVersion":{
"title":"String",
"type":"string",
"description":"study version."
},
"VisitFormsEhrMappingDto":{
"title":"VisitFormsEhrMappingDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Visit GUID",
"format":"uuid"
},
"FormsEhrMappingDto":{
"title":"FormsEhrMappingDto v1.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"ItemsEhrMappingDto":{
"title":"ItemsEhrMappingDto v1.0",
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Item GUID",
"format":"uuid"
},
"FormItemAdvancedPropDto":{
"title":"From Item Advanced Property v17.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov17"
}
}
},
"description":"Form Item Advanced Property"
}
},
"description":"Information about EhrMappings of form item"
}
},
"description":"Information about EhrMappings of items of the form"
}
},
"description":"Information about EhrMappings of items of the forms associated with a visit"
}
},
"description":"Information about EhrMappings of items of the forms associated with visits of requested study version"
},
"FormItemSummaryDTOV2":{
"title":"FormItemSummaryDto v2.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Item Unique GUID",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form item reference name.",
"example":"NUMBER_01"
},
"questionType":{
"title":"FormItemType",
"type":"string",
"description":"Question type",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"questionLabel":{
"type":"string",
"description":"Form question label",
"example":"Age"
},
"subItemIds":{
"title":"Sub item ids",
"type":"string",
"description":"List of sub question ids",
"format":"uuid"
}
},
"description":"Reduced form item properties"
},
"FormSummaryFlatDtoV2":{
"title":"FormSummaryDto v2.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"refname":{
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"title":{
"type":"string",
"description":"Form title",
"example":"Demography"
},
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemSummaryDTOV2"
}
}
},
"description":"Reduced form properties"
},
"VisitSummaryWithFormIdsDto":{
"required":[
"branchCycleCount",
"branchStartCycle",
"isDispensed",
"sdvRequired",
"shortName",
"studyVersion",
"title"
],
"type":"object",
"properties":{
"visitSeq":{
"type":"integer",
"format":"int32"
},
"branchTier":{
"type":"integer",
"format":"int32"
},
"branchIndex":{
"type":"integer",
"format":"int32"
},
"id":{
"type":"string",
"format":"uuid"
},
"title":{
"type":"string"
},
"shortName":{
"type":"string"
},
"fullName":{
"type":"string"
},
"eventType":{
"type":"string"
},
"branchId":{
"type":"string",
"format":"uuid"
},
"branchTitle":{
"type":"string"
},
"branchShortName":{
"type":"string"
},
"branchIsCycle":{
"type":"boolean"
},
"branchStartCycle":{
"type":"integer",
"format":"int32"
},
"branchCycleCount":{
"type":"number"
},
"isDispensed":{
"type":"boolean"
},
"studyVersion":{
"type":"string"
},
"sdvRequired":{
"type":"string",
"enum":[
"NOTSET",
"NEVER",
"ALWAYS",
"CRITICAL"
]
},
"formIds":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
}
}
},
"VisitsFormsSummaryDto":{
"type":"object",
"properties":{
"studyVersion":{
"type":"string"
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitSummaryWithFormIdsDto"
}
},
"forms":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormSummaryFlatDtoV2"
}
}
}
},
"FormChoiceItemDtov19":{
"title":"FormChoiceItemDto v19.0",
"required":[
"display",
"options",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Choice Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
},
{
"type":"object",
"properties":{
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov19"
}
},
"display":{
"pattern":"selectbox|checkbox|radioset|label",
"type":"string",
"description":"Form choice item display in UI - Selectbox.",
"example":"selectbox"
},
"columnLayout":{
"type":"string",
"description":"Coumn Layout codelist ID",
"example":"EBCF17C5F8D4460AA4A9673485C79CF0"
},
"columnLayoutLabel":{
"type":"string",
"description":"Coumn Layout Label in UI",
"example":"Single"
},
"options":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDtov19"
}
},
"clTitle":{
"type":"string",
"description":"Codelist title only for choice type formitem",
"example":"Gender"
},
"clDescription":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Codelist description only for choice type formitem",
"example":"Standard gender codelist"
},
"isCodeListReplaced":{
"type":"boolean",
"description":"Indicates if the choice option codelist is replaced",
"example":true
}
}
}
]
},
"FormCopySourceDtov19":{
"title":"FormCopySourceDto v19.0",
"type":"object",
"properties":{
"FormId":{
"type":"string",
"description":"Source Form GUID",
"format":"uuid"
},
"id":{
"type":"string",
"description":"Source Study GUID",
"format":"uuid"
},
"StudyTitle":{
"type":"string",
"description":"Source Study title",
"example":"Study-s1"
},
"versionstart":{
"type":"boolean",
"description":"is Rules Copied",
"example":false
}
},
"description":"Form Copy Source Information"
},
"FormDatetimeItemDtov19":{
"title":"FormDatetimeItemDto v19.0",
"required":[
"format",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form DateTime Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
},
{
"type":"object",
"properties":{
"format":{
"type":"string",
"description":"Date time format",
"example":"DD-MON-YYYY"
},
"allowPartialDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow partial date",
"format":"int32",
"example":1
},
"partialDate":{
"type":"string",
"description":"Partial date format",
"example":"Jan-1993"
},
"allowFutureDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow future date",
"format":"int32",
"example":1
}
}
}
]
},
"FormDtov19":{
"title":"FormDto v19.0",
"required":[
"refname",
"title"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form title",
"example":"Demography"
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"repeat":{
"type":"boolean",
"description":"Form repeating?",
"example":false
},
"source":{
"$ref":"#/components/schemas/FormCopySourceDtov19"
},
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov19"
}
},
"versionStart":{
"type":"string",
"description":"The form's version date",
"format":"date-time"
},
"allowMultipleInstances":{
"type":"boolean",
"description":"Allow multiple instances",
"example":true
},
"dynamic":{
"type":"integer",
"description":"Count of forms items that point to this form for Show Form feature",
"format":"int32",
"example":4
},
"formType":{
"type":"string",
"description":"Form type",
"example":"STANDARD_FORM",
"enum":[
"STANDARD_FORM",
"LAB_FORM",
"TWO_SECTION_FORM",
"DRUG_RECONCILIATION_FORM",
"STANDARD_FORM, LAB_FORM, TWO_SECTION_FORM"
]
},
"hasRevision":{
"type":"boolean",
"description":"Indicate whether any revisions from a newer study version have been applied",
"example":true
},
"linkFrom":{
"type":"array",
"description":"linked from forms",
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov19"
}
},
"showFrom":{
"type":"array",
"description":"show dynamic parent from forms of same visit",
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov19"
}
},
"assignedVisits":{
"type":"array",
"description":"branch cycle information describing the visits on which the forms are displayed",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov19"
}
},
"includeInSafetyCaseData":{
"type":"boolean",
"description":"Is form associated to Safety Case Forms",
"example":true
},
"formCategory":{
"type":"string",
"description":"Form category",
"example":"DCS"
},
"formSubcategory":{
"type":"array",
"description":"Form subcategory list",
"items":{
"type":"string",
"description":"Form subcategory list"
}
},
"logoFileName":{
"type":"string",
"description":"Logo File Name"
},
"logoFileUploadRequest":{
"$ref":"#/components/schemas/FileUploadRequest"
}
},
"description":"Form Info"
},
"FormExistingDataItemDtov19":{
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form existing data item Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
},
{
"type":"object",
"properties":{
"codeName":{
"type":"string",
"description":"Codelist name for existing data, must be a value from ExistingDataLabels codelist",
"example":"EDLSite"
},
"codeValue":{
"type":"string",
"description":"Codelist value specifying existing data, must be a value from codelist defined in codeName",
"example":"SiteName"
}
}
}
]
},
"FormFileUploadItemDto":{
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
}
]
},
"FormInstructionalTextItemDtov19":{
"title":"FormInstructionalTextItem v19.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Instructional information about the form or question",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
},
{
"type":"object",
"properties":{
"instructionalText":{
"type":"string",
"description":"Instructional information about the form or question",
"example":"Complete all parts of the form"
}
}
}
]
},
"FormItemAdvancedPropDtov19":{
"title":"From Item Advanced Property v19.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov19"
}
}
},
"description":"Form Item Advanced Property"
},
"FormItemAdvancedPropRuleDtov19":{
"title":"From Item Advanced Property Rule v19.0",
"type":"object",
"properties":{
"name":{
"type":"string",
"description":"name",
"example":"RolloverQuestionAnswer"
},
"value":{
"type":"string",
"description":"For RolloverQuestion property it is an ECDV_CODELISTITEM.CODELISTITEM_ID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"For RolloverQuestion property it is an ECDV_CODELISTITEM.VALUE",
"example":"Yes"
}
},
"description":"Form Item Advanced Property Rule"
},
"FormItemAdvancedPropWithParentDtov19":{
"title":"From Item Advanced Property With Parent v19.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended Property ID",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"parent object ID",
"format":"uuid"
},
"rules":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov19"
}
},
"parentObjectLabel":{
"type":"string",
"description":"parent object name",
"example":"Form 1"
},
"parentObjectLevel":{
"type":"string",
"description":"type of parent object",
"example":"FORM"
}
},
"description":"Form Item Advanced Property with Parent Info"
},
"FormItemDtov19":{
"title":"FormItemDto v19.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"properties":{
"questionType":{
"title":"FormItemType",
"type":"string",
"description":"Question type",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"id":{
"type":"string",
"description":"Form Item Unique GUID",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formTitle":{
"type":"string",
"description":"Form title",
"example":"Demography"
},
"questionLabel":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form question label",
"example":"Age"
},
"questionHint":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Form question hint",
"example":"What is your age?"
},
"randomizationTag":{
"type":"boolean",
"description":"Flag that indicates whether this form item should be used for randomization stratification or not.",
"example":true
},
"isStrataFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization stratum or not.",
"example":false
},
"isCohortFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization cohort or not.",
"example":false
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form item reference name.",
"example":"NUMBER_01"
},
"applyChangeToVersion":{
"type":"string",
"description":"For IPR apply change to version",
"example":"1.0.0.1"
},
"required":{
"type":"boolean",
"description":"Whether this form item is requiered or not.",
"example":true
},
"dynamic":{
"type":"integer",
"description":"How many leading questions in this form have to be answered by user correctly before Item is included into the form.",
"format":"int32",
"example":1
},
"hidden":{
"type":"boolean",
"description":"Is form item hidden?",
"example":false
},
"readOnly":{
"type":"boolean",
"description":"Is form item read only?",
"example":false
},
"ruleSet":{
"type":"string",
"description":"A JSON-formatted set of rules to do validation of the answers.",
"example":"{'logicalOperator':'NONE','rules':[],'numberIndex':1}"
},
"sdvRequired":{
"type":"string",
"description":"Source Data Verification Type",
"example":"NEVER(0),ALWAYS(1),CRITICAL(2)",
"enum":[
"NOTSET",
"NEVER",
"ALWAYS",
"CRITICAL"
]
},
"sequence":{
"type":"integer",
"description":"Item position in the form.",
"format":"int32",
"example":1
},
"groupSequence":{
"type":"integer",
"description":"Group sequence.",
"format":"int32"
},
"smartItemId":{
"type":"string",
"description":"Smart item Unique GUID",
"format":"uuid"
},
"formula":{
"type":"string",
"description":"Smart item formula.",
"example":"[{'ruleName':'AGE','ruleExpression':'AgeInYears(AGE_DOB_01, visitDate)'}]"
},
"smartObject":{
"type":"string",
"description":"Smart object.",
"example":"AGE"
},
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov19"
}
},
"sasVariable":{
"type":"string",
"description":"Form Item SASVariable",
"example":"AE"
},
"sasLabel":{
"type":"string",
"description":"Form Item sasLabel",
"example":"Adverse Event"
},
"labNormalsTag":{
"type":"string",
"description":"Lab Normals Tag used in dialog tagging",
"example":"LabTest, LabUnit, LabLowRange, LabHighRange, LabStandardResult"
},
"clLabNormalsTag":{
"type":"string",
"description":"Code list Lab Normals Tag used in the code list dialog tagging",
"example":"LabTest, LabUnit, LabGender, LabRace, LabStandardResult"
},
"dataClassificationIds":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov19"
}
},
"requiredScreening":{
"type":"boolean",
"description":"Form items tagged as screening will are used as the minimum data collected on a Screening Event.",
"example":false
},
"requiredRandomization":{
"type":"boolean",
"description":"Form items tagged as randomization will are used as the minimum data collected on a Randomization Event.",
"example":false
},
"requiredDispensation":{
"type":"boolean",
"description":"Form items tagged as dispensation will are used as the minimum data collected on a Dispensation Event.",
"example":false
},
"requiredForCaseCreate":{
"type":"boolean",
"description":"Form items tagged as required for case create are mandatory as the minimum data collected on a Safety Case collection.",
"example":false
},
"triggerFollowupCase":{
"type":"boolean",
"description":"Form items tagged as trigger followup case are having safety rules enabled for safety rules creation.",
"example":false
},
"dataClassificationLevel":{
"type":"string",
"description":"Data classification level if applicable",
"example":"edit, view"
},
"e2br3Mapping":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov19"
}
}
},
"description":"Form Item Information",
"discriminator":{
"propertyName":"questionType",
"mapping":{
"datetime":"#/components/schemas/FormDatetimeItemDtov19",
"numeric":"#/components/schemas/FormNumberItemDtov19",
"measurement":"#/components/schemas/FormNumberItemDtov19",
"text":"#/components/schemas/FormTextItemDtov19",
"choice":"#/components/schemas/FormChoiceItemDtov19",
"questionGroup":"#/components/schemas/FormQuestionGroupItemDtov19",
"table":"#/components/schemas/FormTableItemDtov19",
"section":"#/components/schemas/FormSectionalItemDtov19",
"label":"#/components/schemas/FormInstructionalTextItemDtov19",
"existingData":"#/components/schemas/FormExistingDataItemDtov19",
"fileUpload":"#/components/schemas/FormFileUploadItemDto"
}
},
"oneOf":[
{
"$ref":"#/components/schemas/FormNumberItemDtov19"
},
{
"$ref":"#/components/schemas/FormChoiceItemDtov19"
},
{
"$ref":"#/components/schemas/FormTextItemDtov19"
},
{
"$ref":"#/components/schemas/FormDatetimeItemDtov19"
},
{
"$ref":"#/components/schemas/FormQuestionGroupItemDtov19"
},
{
"$ref":"#/components/schemas/FormTableItemDtov19"
},
{
"$ref":"#/components/schemas/FormSectionalItemDtov19"
},
{
"$ref":"#/components/schemas/FormLabelItemDto"
},
{
"$ref":"#/components/schemas/FormInstructionalTextItemDtov19"
},
{
"$ref":"#/components/schemas/FormExistingDataItemDtov19"
},
{
"$ref":"#/components/schemas/FormFileUploadItemDto"
}
]
},
"FormLinkFromDtov19":{
"title":"FormLinkFromDto v19.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"items":{
"type":"array",
"description":"Form items",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov19"
}
},
"parentAssignedVisits":{
"type":"array",
"description":"Parent Assigned Visits",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov19"
}
}
},
"description":"Linked From Form Details"
},
"FormNumberItemDtov19":{
"title":"FormNumberItemDto v19.0",
"required":[
"precision",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Number Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
},
{
"type":"object",
"properties":{
"precision":{
"minimum":0,
"type":"integer",
"description":"Number value precision",
"format":"int32",
"example":1
},
"units":{
"type":"string",
"description":"Units of measure",
"example":"kg"
}
}
}
]
},
"FormOptionDtov19":{
"title":"FormOptionDto v19.0",
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox label for a one specific choice.",
"example":"Female"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox value for a one specific choice.",
"example":"1"
},
"clCode":{
"type":"string",
"description":"Codelist code for a one specific choice.",
"example":"1"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description for a one specific choice.",
"example":"1"
},
"clValue":{
"type":"string",
"description":"Codelist value for a one specific choice.",
"example":"1"
},
"clItemId":{
"type":"string",
"description":"Codelist item id for a one specific choice.",
"format":"uuid"
},
"hidden":{
"type":"boolean",
"description":"Is form item option hidden?",
"example":false
},
"optionSeq":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice sequence value for a one specific choice.",
"example":"1"
}
},
"description":"Form choice item option details"
},
"FormQuestionGroupItemDtov19":{
"title":"FormQuestionGroupItemDto v19.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Question Group Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
}
]
},
"FormSectionalItemDtov19":{
"title":"FormSectionalItemDto v19.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Section Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
}
]
},
"FormTableItemDtov19":{
"title":"FormTableItemDto v19.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form table Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
},
{
"type":"object",
"properties":{
"allowAdditionalRows":{
"type":"boolean"
}
}
}
]
},
"FormTextItemDtov19":{
"title":"FormTextItemDto v19.0",
"required":[
"maxlength",
"multiline",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form text Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov19"
},
{
"type":"object",
"properties":{
"maxlength":{
"maximum":4000,
"minimum":0,
"type":"integer",
"description":"Form text item max length",
"format":"int32",
"example":4000
},
"multiline":{
"type":"boolean",
"description":"Is form text item multiline",
"example":false
}
}
}
]
},
"FormChoiceItemDtov21":{
"title":"FormChoiceItemDto v21.0",
"required":[
"display",
"options",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Choice Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov21"
}
},
"display":{
"pattern":"selectbox|checkbox|radioset|label",
"type":"string",
"description":"Form choice item display in UI - Selectbox.",
"example":"selectbox"
},
"columnLayout":{
"type":"string",
"description":"Coumn Layout codelist ID",
"example":"EBCF17C5F8D4460AA4A9673485C79CF0"
},
"columnLayoutLabel":{
"type":"string",
"description":"Coumn Layout Label in UI",
"example":"Single"
},
"options":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormOptionDtov21"
}
},
"clTitle":{
"type":"string",
"description":"Codelist title only for choice type formitem",
"example":"Gender"
},
"clDescription":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Codelist description only for choice type formitem",
"example":"Standard gender codelist"
},
"isCodeListReplaced":{
"type":"boolean",
"description":"Indicates if the choice option codelist is replaced",
"example":true
},
"codelistType":{
"type":"string",
"description":"Form items field to indicate dynamic or static variant of the codelist mapped to item. ",
"enum":[
"STATIC, DYNAMIC"
]
},
"codelistId":{
"type":"string",
"description":"ID of the codelist used in the question ",
"format":"uuid"
},
"codelistLang":{
"type":"string",
"description":"Language of the codelist used in the question ",
"example":"en-US"
}
}
}
]
},
"FormCopySourceDtov21":{
"title":"FormCopySourceDto v21.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Source form ID (UUID).",
"format":"uuid"
},
"studyId":{
"type":"string",
"description":"Source study ID (UUID).",
"format":"uuid"
},
"studyTitle":{
"type":"string",
"description":"Source study title.",
"example":"Study-s1"
},
"versionStart":{
"type":"string",
"description":"Source version start timestamp.",
"format":"date-time",
"example":"2025-04-30T09:24:15Z"
},
"rules":{
"type":"boolean",
"description":"Indicates whether rules were copied from the source form.",
"example":false
}
},
"description":"Form Copy Source Information",
"example":{
"studyId":"B1B8327AFAA6412287106192AB5984EF",
"studyTitle":"Study-s1",
"formId":"B1B8327AFAA6412287106192AB5984EA",
"versionStart":"2025-04-30T09:24:15Z",
"rules":false
}
},
"FormDatetimeItemDtov21":{
"title":"FormDatetimeItemDto v21.0",
"required":[
"format",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form DateTime Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"format":{
"type":"string",
"description":"Date time format",
"example":"DD-MON-YYYY"
},
"allowPartialDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow partial date",
"format":"int32",
"example":1
},
"partialDate":{
"type":"string",
"description":"Partial date format",
"example":"Jan-1993"
},
"allowFutureDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Allow future date",
"format":"int32",
"example":1
}
}
}
]
},
"FormDtov21":{
"title":"FormDto v21.0",
"required":[
"refname",
"title"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Form ID (UUID).",
"format":"uuid"
},
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form title",
"example":"Demography"
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form refname",
"example":"FORM_01"
},
"repeat":{
"type":"boolean",
"description":"Form repeating?",
"example":false
},
"source":{
"$ref":"#/components/schemas/FormCopySourceDtov21"
},
"items":{
"type":"array",
"description":"Form item definitions.",
"example":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"formId":"B1B8327AFAA6412287106192AB5984EA",
"questionType":"numeric",
"questionLabel":"Age",
"refname":"AGE_01",
"required":true,
"sdvRequired":"NEVER"
}
],
"items":{
"$ref":"#/components/schemas/FormItemDtov21"
}
},
"versionStart":{
"type":"string",
"description":"The form version start timestamp.",
"format":"date-time",
"example":"2025-04-30T09:24:15Z"
},
"allowMultipleInstances":{
"type":"boolean",
"description":"Allow multiple instances",
"example":true
},
"dynamic":{
"type":"integer",
"description":"Count of forms items that point to this form for Show Form feature",
"format":"int32",
"example":4
},
"formType":{
"type":"string",
"description":"Form type",
"example":"STANDARD_FORM",
"enum":[
"STANDARD_FORM",
"LAB_FORM",
"TWO_SECTION_FORM",
"DRUG_RECONCILIATION_FORM",
"STANDARD_FORM, LAB_FORM, TWO_SECTION_FORM"
]
},
"hasRevision":{
"type":"boolean",
"description":"Indicate whether any revisions from a newer study version have been applied",
"example":true
},
"linkFrom":{
"type":"array",
"description":"Forms linked to this form.",
"example":[
{
"formId":"B1B8327AFAA6412287106192AB5984EF",
"items":[
"B1B8327AFAA6412287106192AB5984EA"
]
}
],
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov21"
}
},
"showFrom":{
"type":"array",
"description":"Dynamic parent dependencies from forms on the same visit.",
"example":[
{
"formId":"B1B8327AFAA6412287106192AB5984EF",
"items":[
{
"id":"B1B8327AFAA6412287106192AB5984EA",
"label":"PARENT_ITEM"
}
],
"parentAssignedVisits":[
{
"id":"B1B8327AFAA6412287106192AB5984EB",
"label":"VISIT_1"
}
]
}
],
"items":{
"$ref":"#/components/schemas/FormLinkFromDtov21"
}
},
"assignedVisits":{
"type":"array",
"description":"Branch-cycle details describing visits where this form is displayed.",
"example":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"label":"VISIT_1"
}
],
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov21"
}
},
"includeInSafetyCaseData":{
"type":"boolean",
"description":"Is form associated to Safety Case Forms",
"example":true
},
"formCategory":{
"type":"string",
"description":"Form category",
"example":"DCS"
},
"formSubcategory":{
"type":"array",
"description":"Form subcategory list.",
"example":[
"SCREENING",
"BASELINE"
],
"items":{
"type":"string",
"description":"Form subcategory list.",
"example":"[\"SCREENING\",\"BASELINE\"]"
}
},
"logoFileName":{
"type":"string",
"description":"Logo file name.",
"example":"study-logo.png"
},
"logoFileUploadRequest":{
"$ref":"#/components/schemas/FileUploadRequest"
}
},
"description":"Form Info"
},
"FormExistingDataItemDtov21":{
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form existing data item Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"codeName":{
"type":"string",
"description":"Codelist name for existing data, must be a value from ExistingDataLabels codelist",
"example":"EDLSite"
},
"codeValue":{
"type":"string",
"description":"Codelist value specifying existing data, must be a value from codelist defined in codeName",
"example":"SiteName"
}
}
}
]
},
"FormFileUploadItemDtov21":{
"title":"FormFileUploadItemDto v21.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form File Upload Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
}
]
},
"FormInstructionalTextItemDtov21":{
"title":"FormInstructionalTextItemDto v21.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Instructional Text Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"instructionalText":{
"type":"string",
"description":"Instructional text content",
"example":"Please fill this form carefully"
}
}
}
]
},
"FormItemAdvancedPropDtov21":{
"title":"FormItemAdvancedPropDto v21.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended property ID (UUID).",
"format":"uuid"
},
"type":{
"type":"string",
"description":"Advanced property type.",
"example":"RolloverQuestion"
},
"name":{
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"description":"Advanced property rules list.",
"example":[
{
"name":"RolloverQuestionAnswer",
"value":"B1B8327AFAA6412287106192AB5984EF",
"label":"Yes"
}
],
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov21"
}
}
},
"description":"Form Item Advanced Property"
},
"FormItemAdvancedPropRuleDtov21":{
"title":"FormItemAdvancedPropRuleDto v21.0",
"type":"object",
"properties":{
"name":{
"type":"string",
"description":"Rule name.",
"example":"RolloverQuestionAnswer"
},
"value":{
"type":"string",
"description":"Rule value.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rule label.",
"example":"Yes"
}
},
"description":"Form Item Advanced Property Rule"
},
"FormItemAdvancedPropWithParentDtov21":{
"title":"From Item Advanced Property With Parent v21.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Extended property ID (UUID).",
"format":"uuid"
},
"type":{
"type":"string",
"description":"Advanced property type.",
"example":"RolloverQuestion"
},
"name":{
"type":"string",
"description":"Advanced property name",
"example":"RolloverQuestionStudyId"
},
"value":{
"type":"string",
"description":"Advanced property value. For example, rollover study UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Rollover study name",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"description":"Advanced property rules list.",
"example":[
{
"name":"RolloverQuestionAnswer",
"value":"B1B8327AFAA6412287106192AB5984EF",
"label":"Yes"
}
],
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropRuleDtov21"
}
},
"parentObjectId":{
"type":"string",
"description":"Parent object ID (UUID).",
"format":"uuid"
},
"parentObjectLabel":{
"type":"string",
"description":"parent object name",
"example":"Form 1"
},
"parentObjectLevel":{
"type":"string",
"description":"type of parent object",
"example":"FORM"
}
},
"description":"Form Item Advanced Property with Parent Info"
},
"FormItemDtov21":{
"title":"FormItemDto v21.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"properties":{
"questionType":{
"title":"FormItemType",
"type":"string",
"description":"Question type",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"id":{
"type":"string",
"description":"Form item ID (UUID).",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form ID (UUID).",
"format":"uuid"
},
"visitIds":{
"type":"array",
"description":"Visits associated",
"format":"List",
"example":"[B1B8327AFAA6412287106192AB5984EF, B1B8327AFAA6412287106192AB5984EA]",
"items":{
"type":"string",
"description":"Visits associated",
"format":"uuid"
}
},
"formTitle":{
"type":"string",
"description":"Form title",
"example":"Demography"
},
"questionLabel":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form question label",
"example":"Age"
},
"questionHint":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Form question hint",
"example":"What is your age?"
},
"randomizationTag":{
"type":"boolean",
"description":"Flag that indicates whether this form item should be used for randomization stratification or not.",
"example":true
},
"isStrataFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization stratum or not.",
"example":false
},
"isCohortFactor":{
"type":"boolean",
"description":"Flag that indicates whether this form item is used as a factor for randomization cohort or not.",
"example":false
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form item reference name.",
"example":"NUMBER_01"
},
"applyChangeToVersion":{
"type":"string",
"description":"For IPR apply change to version",
"example":"1.0.0.1"
},
"required":{
"type":"boolean",
"description":"Whether this form item is requiered or not.",
"example":true
},
"dynamic":{
"type":"integer",
"description":"How many leading questions in this form have to be answered by user correctly before Item is included into the form.",
"format":"int32",
"example":1
},
"hidden":{
"type":"boolean",
"description":"Is form item hidden?",
"example":false
},
"readOnly":{
"type":"boolean",
"description":"Is form item read only?",
"example":false
},
"ruleSet":{
"type":"string",
"description":"A JSON-formatted set of rules to do validation of the answers.",
"example":"{'logicalOperator':'NONE','rules':[],'numberIndex':1}"
},
"sdvRequired":{
"type":"string",
"description":"Source Data Verification Type",
"example":"NEVER(0),ALWAYS(1),CRITICAL(2)",
"enum":[
"NOTSET",
"NEVER",
"ALWAYS",
"CRITICAL"
]
},
"sequence":{
"type":"integer",
"description":"Item position in the form.",
"format":"int32",
"example":1
},
"groupSequence":{
"type":"integer",
"description":"Group sequence.",
"format":"int32",
"example":3
},
"smartItemId":{
"type":"string",
"description":"Smart item ID (UUID).",
"format":"uuid"
},
"formula":{
"type":"string",
"description":"Smart item formula.",
"example":"[{'ruleName':'AGE','ruleExpression':'AgeInYears(AGE_DOB_01, visitDate)'}]"
},
"smartObject":{
"type":"string",
"description":"Smart object.",
"example":"AGE"
},
"advancedProps":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov21"
}
},
"sasVariable":{
"type":"string",
"description":"Form Item SASVariable",
"example":"AE"
},
"sasLabel":{
"type":"string",
"description":"Form Item sasLabel",
"example":"Adverse Event"
},
"labNormalsTag":{
"type":"string",
"description":"Lab Normals Tag used in dialog tagging",
"example":"LabTest, LabUnit, LabLowRange, LabHighRange, LabStandardResult"
},
"clLabNormalsTag":{
"type":"string",
"description":"Code list Lab Normals Tag used in the code list dialog tagging",
"example":"LabTest, LabUnit, LabGender, LabRace, LabStandardResult"
},
"dataClassificationIds":{
"type":"array",
"description":"Data classification entries.",
"example":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"type":"DATA_CLASSIFICATION",
"name":"CLASSIFICATION_ID",
"value":"B1B8327AFAA6412287106192AB5984EF",
"label":"Confidential"
}
],
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov21"
}
},
"requiredScreening":{
"type":"boolean",
"description":"Form items tagged as screening will are used as the minimum data collected on a Screening Event.",
"example":false
},
"requiredRandomization":{
"type":"boolean",
"description":"Form items tagged as randomization will are used as the minimum data collected on a Randomization Event.",
"example":false
},
"requiredDispensation":{
"type":"boolean",
"description":"Form items tagged as dispensation will are used as the minimum data collected on a Dispensation Event.",
"example":false
},
"requiredForCaseCreate":{
"type":"boolean",
"description":"Form items tagged as required for case create are mandatory as the minimum data collected on a Safety Case collection.",
"example":false
},
"triggerFollowupCase":{
"type":"boolean",
"description":"Form items tagged as trigger followup case are having safety rules enabled for safety rules creation.",
"example":false
},
"dataClassificationLevel":{
"type":"string",
"description":"Data classification level if applicable",
"example":"edit, view"
},
"e2br3Mapping":{
"type":"array",
"description":"E2B R3 mapping entries.",
"example":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"type":"E2BR3",
"name":"E2B_FIELD",
"value":"PATIENT_AGE",
"label":"Patient Age"
}
],
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropDtov21"
}
}
},
"description":"Form Item Information",
"discriminator":{
"propertyName":"questionType",
"mapping":{
"datetime":"#/components/schemas/FormDatetimeItemDtov21",
"numeric":"#/components/schemas/FormNumberItemDtov21",
"measurement":"#/components/schemas/FormNumberItemDtov21",
"text":"#/components/schemas/FormTextItemDtov21",
"choice":"#/components/schemas/FormChoiceItemDtov21",
"questionGroup":"#/components/schemas/FormQuestionGroupItemDtov21",
"table":"#/components/schemas/FormTableItemDtov21",
"section":"#/components/schemas/FormSectionalItemDtov21",
"label":"#/components/schemas/FormInstructionalTextItemDtov21",
"existingData":"#/components/schemas/FormExistingDataItemDtov21",
"fileUpload":"#/components/schemas/FormFileUploadItemDtov21"
}
},
"oneOf":[
{
"$ref":"#/components/schemas/FormNumberItemDtov21"
},
{
"$ref":"#/components/schemas/FormChoiceItemDtov21"
},
{
"$ref":"#/components/schemas/FormTextItemDtov21"
},
{
"$ref":"#/components/schemas/FormDatetimeItemDtov21"
},
{
"$ref":"#/components/schemas/FormQuestionGroupItemDtov21"
},
{
"$ref":"#/components/schemas/FormTableItemDtov21"
},
{
"$ref":"#/components/schemas/FormSectionalItemDtov21"
},
{
"$ref":"#/components/schemas/FormLabelItemDto"
},
{
"$ref":"#/components/schemas/FormInstructionalTextItemDtov21"
},
{
"$ref":"#/components/schemas/FormExistingDataItemDtov21"
},
{
"$ref":"#/components/schemas/FormFileUploadItemDtov21"
}
]
},
"FormLinkFromDtov21":{
"title":"FormLinkFromDto v21.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form ID (UUID).",
"format":"uuid"
},
"items":{
"type":"array",
"description":"Linked parent item details.",
"example":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"label":"PARENT_ITEM"
}
],
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov21"
}
},
"parentAssignedVisits":{
"type":"array",
"description":"Parent assigned visit details.",
"example":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"label":"VISIT_1"
}
],
"items":{
"$ref":"#/components/schemas/FormItemAdvancedPropWithParentDtov21"
}
}
},
"description":"Linked From Form Details",
"example":[
{
"formId":"B1B8327AFAA6412287106192AB5984EF",
"items":[
{
"id":"B1B8327AFAA6412287106192AB5984EA",
"label":"PARENT_ITEM"
}
],
"parentAssignedVisits":[
{
"id":"B1B8327AFAA6412287106192AB5984EB",
"label":"VISIT_1"
}
]
}
]
},
"FormNumberItemDtov21":{
"title":"FormNumberItemDto v21.0",
"required":[
"precision",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Number Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"precision":{
"minimum":0,
"type":"integer",
"description":"Number value precision",
"format":"int32",
"example":1
},
"units":{
"type":"string",
"description":"Units of measure",
"example":"kg"
}
}
}
]
},
"FormOptionDtov21":{
"title":"FormOptionDto v21.0",
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox label for a one specific choice.",
"example":"Female"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice selectbox value for a one specific choice.",
"example":"1"
},
"clCode":{
"type":"string",
"description":"Codelist code for a one specific choice.",
"example":"1"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description for a one specific choice.",
"example":"1"
},
"clValue":{
"type":"string",
"description":"Codelist value for a one specific choice.",
"example":"1"
},
"clItemId":{
"type":"string",
"description":"Codelist item id for a one specific choice.",
"format":"uuid"
},
"hidden":{
"type":"boolean",
"description":"Is form item option hidden?",
"example":false
},
"optionSeq":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Form choice sequence value for a one specific choice.",
"example":"1"
}
},
"description":"Form choice item option details"
},
"FormQuestionGroupItemDtov21":{
"title":"FormQuestionGroupItemDto v21.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Question Group Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormItemDtov21"
}
}
}
}
]
},
"FormSectionalItemDtov21":{
"title":"FormSectionalItemDto v21.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Sectional Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
}
]
},
"FormTableItemDtov21":{
"title":"FormTableItemDto v21.0",
"required":[
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form Table Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"allowAdditionalRows":{
"type":"boolean"
}
}
}
]
},
"FormTextItemDtov21":{
"title":"FormTextItemDto v21.0",
"required":[
"maxlength",
"multiline",
"questionLabel",
"questionType",
"refname",
"required",
"sdvRequired"
],
"type":"object",
"description":"Form text Item Details Information",
"allOf":[
{
"$ref":"#/components/schemas/FormItemDtov21"
},
{
"type":"object",
"properties":{
"maxlength":{
"maximum":4000,
"minimum":0,
"type":"integer",
"description":"Form text item max length",
"format":"int32",
"example":4000
},
"multiline":{
"type":"boolean",
"description":"Is form text item multiline",
"example":false
}
}
}
]
},
"LockObjectDetailsDtoV4":{
"title":"LockObjectDetailsDto v4.0",
"type":"object",
"properties":{
"visitObjects":{
"type":"object",
"additionalProperties":{
"type":"object",
"additionalProperties":{
"$ref":"#/components/schemas/LockObjectVersionDetailsDtoV4"
},
"description":"Locked visit object details."
},
"description":"Locked visit object details."
}
},
"description":"Information about all the locked objects."
},
"LockObjectVersionDetailsDtoV4":{
"title":"LockObjectVersionDetailsDtoV4",
"type":"object",
"properties":{
"visitDetails":{
"$ref":"#/components/schemas/VisitDtoV9"
}
},
"description":"Information about all the locked objects in a version"
},
"VisitDtoV9":{
"title":"VisitDto v9.0",
"required":[
"repeatNumber",
"repeatVisit",
"requiredVisit",
"shortName",
"title"
],
"type":"object",
"properties":{
"branchTitle":{
"type":"string",
"description":"Visit Branch title",
"example":"Branch 2"
},
"fullName":{
"type":"string",
"description":"Concatenation of Visit Title and Branch title with hypen",
"example":"B1C01 - V01"
},
"id":{
"type":"string",
"description":"Visit GUID",
"format":"uuid"
},
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Visit title",
"example":"Week 2"
},
"repeatVisit":{
"type":"boolean",
"description":"Yes - if Visit Design is repeating.",
"example":false
},
"repeatNumber":{
"type":"integer",
"description":"Times to repeat Visit Design.",
"format":"int32",
"example":5
},
"requiredVisit":{
"type":"boolean",
"description":"Yes - if Visit Design is required.",
"example":false
},
"randomization":{
"type":"string",
"description":"Randomization GUID",
"format":"uuid"
},
"lastRequired":{
"type":"boolean",
"description":"Yes - if Visit is last required.",
"example":false
},
"eventType":{
"type":"string",
"description":"Visit event type",
"example":"ScreeningVisit"
},
"shortName":{
"maxLength":16,
"minLength":1,
"pattern":"[a-zA-Z0-9]+",
"type":"string",
"description":"Visit short name",
"example":"Week1"
},
"visitDescription":{
"type":"string",
"description":"Visit description",
"example":"Regular 2 week visit"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date time",
"format":"date-time",
"example":"2019-01-25T07:42:00.204Z"
},
"studyVersion":{
"type":"string",
"description":"Study version",
"example":"1.0.0.1"
},
"studyVersionStatus":{
"type":"string",
"description":"Study version status",
"example":"TESTING"
},
"startVisitId":{
"type":"string",
"description":"Start visit ID",
"format":"uuid"
},
"endVisitId":{
"type":"string",
"description":"End visit ID",
"format":"uuid"
},
"branchId":{
"type":"string",
"description":"Branch Id",
"format":"uuid"
},
"timeLine":{
"type":"integer",
"description":"show in timeline. allows the designer to set when a visit can be shown to a user.",
"format":"int32",
"example":1
}
},
"description":"Visit design."
},
"LockObjectDtoV4":{
"title":"LockObjectDto V4.0",
"required":[
"objectId",
"objectLockVersion",
"objectType"
],
"type":"object",
"properties":{
"objectId":{
"type":"string",
"description":"Object ID",
"format":"uuid"
},
"objectType":{
"title":"ObjectType",
"type":"string",
"description":"Object type",
"example":"form",
"enum":[
"form",
"visit"
]
},
"parentObjectId":{
"type":"string",
"description":"Parent Object ID",
"format":"uuid"
},
"objectLockVersion":{
"title":"ObjectLockVersion",
"type":"string",
"description":"Object lock version",
"example":"1.0.0.1"
},
"objectLockDate":{
"type":"string",
"description":"Object Lock Date",
"format":"date-time"
}
},
"description":"Lock Object details"
},
"LockObjectDtoV5":{
"required":[
"objectId",
"objectLockVersion",
"objectType"
],
"type":"object",
"properties":{
"objectId":{
"type":"string",
"description":"Object ID",
"format":"uuid"
},
"objectType":{
"title":"ObjectType",
"type":"string",
"description":"Object type",
"example":"form",
"enum":[
"form",
"visit"
]
},
"parentObjectId":{
"type":"string",
"description":"Parent Object ID",
"format":"uuid"
},
"objectLockVersion":{
"title":"ObjectLockVersion",
"type":"string",
"description":"Object lock version",
"example":"1.0.0.1"
},
"objectLockDate":{
"type":"string",
"description":"Object Lock Date",
"format":"date-time"
}
}
},
"LibraryHistoryDtoV1":{
"title":"LibraryHistoryDtoV1.0",
"type":"object",
"properties":{
"libraryId":{
"title":"Library ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the library object.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"lastModifiedDate":{
"title":"Last modified date",
"type":"string",
"description":"Date and time when the resource was last modified.",
"format":"date-time",
"example":"2022-08-30T07:59:46.901Z"
},
"libraryVersion":{
"title":"Library version",
"type":"string",
"description":"Version identifier of the library.",
"example":"1.0"
},
"status":{
"title":"Status",
"type":"string",
"description":"Status of the resource.",
"example":"DRAFT"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Unique user identifier (UUID) representing the investigator or system user who modified or interacted with the subject record",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"userName":{
"title":"User name",
"type":"string",
"description":"Name of the user that performed the modification.",
"example":"John Doe"
}
},
"description":"Information about the history of library modifications."
},
"LibraryKitsDtoV1":{
"title":"LibraryKitsDtoV1.0",
"type":"object",
"properties":{
"trialSupplyType":{
"title":"Trial supply type",
"type":"string",
"description":"Trial supply type of the kit.",
"example":"BOTTLE"
},
"storageSetting":{
"title":"Storage setting",
"type":"string",
"description":"Storage setting of the kit.",
"example":"REFRIGERATED",
"enum":[
"AMBIENT",
"REFRIGERATED",
"FROZEN"
]
},
"libraryKitId":{
"title":"Library kit ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the library kit.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"poolingId":{
"title":"Pooling ID",
"type":"string",
"description":"Pooling identifier for the kit.",
"format":"string",
"example":"BPAF"
},
"kitDescription":{
"title":"Kit description",
"type":"string",
"description":"Description of the kit.",
"format":"string",
"example":"Placebo"
},
"unitsPerKit":{
"title":"Units per kit",
"type":"number",
"description":"Number of units per kit.",
"format":"double",
"example":5
},
"status":{
"title":"Status",
"type":"string",
"description":"Status of the resource.",
"example":"DRAFT",
"enum":[
"DRAFT",
"APPROVED",
"ARCHIVED",
"PUBLISHED"
]
}
},
"description":"Information about library kits."
},
"LibraryDtoV1":{
"title":"LibraryDtoV1.0",
"type":"object",
"properties":{
"libraryId":{
"title":"Library ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the library object.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"objectId":{
"title":"Object ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the underlying object (for example, forms or rules).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"objectType":{
"title":"Object type",
"type":"string",
"description":"Type of the underlying object.",
"example":"FORM"
},
"objectGroup":{
"title":"Object group",
"type":"string",
"description":"Object group or title.",
"example":"Demography"
},
"libraryVersion":{
"title":"Library version",
"type":"string",
"description":"Version identifier of the library.",
"example":"1.0"
},
"status":{
"title":"Status",
"type":"string",
"description":"Status of the resource.",
"example":"DRAFT"
},
"description":{
"title":"Description",
"type":"string",
"description":"Description of the library object.",
"example":"Advanced demography form"
},
"tags":{
"title":"Tags",
"type":"string",
"description":"Comma-separated tags associated with the library object.",
"example":"LIB"
},
"studyId":{
"title":"Study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"studyVersion":{
"title":"Study version",
"type":"string",
"description":"String representing the version of the study configuration or protocol. Helps track changes in form or study design.",
"example":"1.0.0.1"
}
},
"description":"Information about a library object."
},
"LibraryCopyObjectDtoV1":{
"title":"LibraryCopyObjectDtoV1.0",
"type":"object",
"properties":{
"objectId":{
"title":"Object ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the underlying object (for example, forms or rules).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"studyId":{
"title":"Study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"studyVersion":{
"title":"Study version",
"type":"string",
"description":"String representing the version of the study configuration or protocol. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"studyType":{
"title":"Study type",
"type":"string",
"description":"Type of the study.",
"example":"LIBRARY"
},
"sourceObjectId":{
"title":"Source object ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the source object used for copy.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"sourceStudyVersion":{
"title":"Source study version",
"type":"string",
"description":"Version identifier of the source study used for copy.",
"example":"1.0.0.1"
},
"sourceStudyId":{
"title":"Source study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the source study used for copy.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"sourceStudyType":{
"title":"Source study type",
"type":"string",
"description":"Type of the source study used for copy.",
"example":"LIBRARY"
},
"objectType":{
"title":"Object type",
"type":"string",
"description":"Type of the underlying object.",
"example":"FORM"
},
"objectGroup":{
"title":"Object group",
"type":"string",
"description":"Object group or title.",
"example":"Demography"
}
},
"description":"Information about a library object copy request."
},
"LibraryUsesDtoV1":{
"title":"LibraryUsesDtoV1.0",
"type":"object",
"properties":{
"libraryId":{
"title":"Library ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the library object.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"objectId":{
"title":"Object ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the underlying object (for example, forms or rules).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"objectType":{
"title":"Object type",
"type":"string",
"description":"Type of the underlying object.",
"example":"FORM"
},
"studyType":{
"title":"Study type",
"type":"string",
"description":"Type of the study.",
"example":"LIBRARY"
},
"studyId":{
"title":"Study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"studyVersion":{
"title":"Study version",
"type":"string",
"description":"String representing the version of the study configuration or protocol. Helps track changes in form or study design.",
"example":"1.0.0.1"
}
},
"description":"Information about how a library object is used in studies."
},
"LibraryCopyObjectDtoV2":{
"title":"LibraryCopyObjectDtoV2.0",
"type":"object",
"properties":{
"associatedForm":{
"type":"boolean"
},
"objectId":{
"title":"Object ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the underlying object (for example, forms or rules).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"studyId":{
"title":"Study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"studyVersion":{
"title":"Study version",
"type":"string",
"description":"String representing the version of the study configuration or protocol. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"studyType":{
"title":"Study type",
"type":"string",
"description":"Type of the study.",
"example":"LIBRARY"
},
"sourceObjectId":{
"title":"Source object ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the source object used for copy.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"sourceStudyVersion":{
"title":"Source study version",
"type":"string",
"description":"Version identifier of the source study used for copy.",
"example":"1.0.0.1"
},
"sourceStudyId":{
"title":"Source study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the source study used for copy.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"sourceStudyType":{
"title":"Source study type",
"type":"string",
"description":"Type of the source study used for copy.",
"example":"LIBRARY"
},
"objectType":{
"title":"Object type",
"type":"string",
"description":"Type of the underlying object.",
"example":"FORM"
},
"objectGroup":{
"title":"Object group",
"type":"string",
"description":"Object group or title.",
"example":"Demography"
},
"isAssociatedForm":{
"title":"Is associated form",
"type":"boolean",
"description":"Indicates whether the form is associated.",
"example":true
}
},
"description":"Information about a library object copy request."
},
"LibraryUsesDtoV2":{
"title":"LibraryUsesDtoV2.0",
"type":"object",
"properties":{
"libraryId":{
"title":"Library ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the library object.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"objectId":{
"title":"Object ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the underlying object (for example, forms or rules).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"objectType":{
"title":"Object type",
"type":"string",
"description":"Type of the underlying object.",
"example":"FORM"
},
"studyType":{
"title":"Study type",
"type":"string",
"description":"Type of the study.",
"example":"LIBRARY"
},
"studyId":{
"title":"Study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"studyVersion":{
"title":"Study version",
"type":"string",
"description":"String representing the version of the study configuration or protocol. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"versionStart":{
"title":"Version start",
"type":"string",
"description":"Uses version start timestamp.",
"format":"date-time",
"example":"2023-08-30T07:59:46.901Z"
},
"relationType":{
"title":"Relation type",
"type":"string",
"description":"Relationship type describing how the library object is used.",
"example":"LIBRARY_ROOT",
"enum":[
"LIBRARY_ROOT, IMPORT_FROM_LIBRARY, IMPORT_FROM_LIBRARY_MODIFIED"
]
},
"librarySourceStudyId":{
"title":"Library source study ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of source study where the library was created.",
"example":"B1B8327AFAA6412287106192AB5984EF"
}
},
"description":"Information about how a library object is used in studies."
},
"Error details DTO":{
"type":"object",
"properties":{
"errorCode":{
"type":"string",
"description":"Machine-readable error code that identifies the failure.",
"readOnly":true,
"example":"QRY-5000"
},
"errorMessage":{
"type":"string",
"description":"Human-readable explanation describing why the request failed.",
"readOnly":true,
"example":"Unexpected server error."
},
"details":{
"$ref":"#/components/schemas/QueryRestErrorDetail"
}
},
"description":"Standard structure used to describe errors returned by Query APIs.",
"example":{
"errorCode":"QRY-5000",
"errorMessage":"Unexpected server error.",
"details":{
"requestId":"3b3b8f31-87a3-4dd2-8b9d-21d0c93ef27a",
"supportCode":"QRY-5000",
"hint":"Retry request after verifying the study mode."
}
}
},
"QueryRestErrorDetail":{
"type":"object",
"properties":{
"requestId":{
"type":"string",
"description":"Unique identifier that can be supplied to Oracle Support when troubleshooting.",
"example":"3b3b8f31-87a3-4dd2-8b9d-21d0c93ef27a"
},
"supportCode":{
"type":"string",
"description":"Support or incident code associated with the error source.",
"example":"QRY-5000"
},
"hint":{
"type":"string",
"description":"Client-facing guidance that clarifies how to resolve or retry the request.",
"example":"Retry request after verifying the study mode."
}
},
"description":"Context object returned when additional error metadata is available.",
"readOnly":true,
"example":{
"requestId":"3b3b8f31-87a3-4dd2-8b9d-21d0c93ef27a",
"supportCode":"QRY-5000",
"hint":"Retry request"
}
},
"StudyOpenQueryCountDTO":{
"title":"StudyOpenQueryCountDTO v1.0",
"type":"object",
"properties":{
"opened":{
"type":"integer",
"description":"Number of queries currently in the Open state. Negative values are not allowed.",
"format":"int32",
"example":2
},
"answered":{
"type":"integer",
"description":"Number of queries currently in the Answered state. Negative values are not allowed.",
"format":"int32",
"example":0
},
"closed":{
"type":"integer",
"description":"Number of queries currently in the Closed state. Negative values are not allowed.",
"format":"int32",
"example":1
}
},
"description":"Payload containing open, answered, and closed query totals for a single study.",
"example":{
"opened":3,
"answered":1,
"closed":2
}
},
"StudyOpenQueryCountRespDTO":{
"title":"StudyOpenQueryCountRespDTO v1.0",
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Overall execution status. Value is success when result is populated and failed when errorData is returned.",
"readOnly":true,
"example":"success",
"enum":[
"success",
"failed"
]
},
"result":{
"$ref":"#/components/schemas/StudyOpenQueryCountDTO"
},
"errorData":{
"$ref":"#/components/schemas/Error details DTO"
},
"version":{
"type":"string",
"description":"Semantic version of the response envelope.",
"readOnly":true,
"example":"1"
}
},
"description":"Envelope that returns open, answered, and closed query totals for a study."
},
"StudyQueryCountDTO":{
"title":"StudyQueryCountDTO v1.0",
"type":"object",
"properties":{
"candidate":{
"type":"integer",
"description":"Number of queries currently in the Candidate state. Negative values are not allowed.",
"format":"int32",
"example":1
},
"opened":{
"type":"integer",
"description":"Number of queries currently in the Open state. Negative values are not allowed.",
"format":"int32",
"example":2
},
"answered":{
"type":"integer",
"description":"Number of queries currently in the Answered state. Negative values are not allowed.",
"format":"int32",
"example":0
},
"deleted":{
"type":"integer",
"description":"Number of queries currently in the Deleted state. Negative values are not allowed.",
"format":"int32",
"example":4
},
"closed":{
"type":"integer",
"description":"Number of queries currently in the Closed state. Negative values are not allowed.",
"format":"int32",
"example":1
}
},
"description":"Payload containing lifecycle totals for queries within a study.",
"example":{
"candidate":1,
"opened":3,
"answered":2,
"deleted":0,
"closed":4
}
},
"StudyQueryCountRespDTO":{
"title":"StudyQueryCountRespDTO v1.0",
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Overall execution status. Value is success when result is populated and failed when errorData is returned.",
"readOnly":true,
"example":"success",
"enum":[
"success",
"failed"
]
},
"result":{
"$ref":"#/components/schemas/StudyQueryCountDTO"
},
"errorData":{
"$ref":"#/components/schemas/Error details DTO"
},
"version":{
"type":"string",
"description":"Semantic version of the response envelope.",
"readOnly":true,
"example":"1"
}
},
"description":"Envelope that returns lifecycle totals for queries within a study."
},
"Response DTO":{
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Overall execution status. Value is success when result is populated and failed when errorData is returned.",
"readOnly":true,
"example":"success",
"enum":[
"success",
"failed"
]
},
"result":{
"type":"object",
"description":"Result payload returned when status equals success.",
"example":{
"opened":3,
"answered":1,
"closed":2
}
},
"errorData":{
"$ref":"#/components/schemas/Error details DTO"
},
"version":{
"type":"string",
"description":"Semantic version of the response envelope.",
"readOnly":true,
"example":"1"
}
},
"description":"Base envelope returned by Query APIs. Use the status field to determine whether result or errorData is populated.",
"example":"{\\n \\\"status\\\": \\\"success\\\",\\n \\\"result\\\": {\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"state\\\": \\\"Answered\\\"\\n },\\n \\\"errorData\\\": null,\\n \\\"version\\\": \\\"1\\\"\\n}"
},
"PaginationParamDTO":{
"type":"object",
"properties":{
"orderasc":{
"type":"boolean"
},
"limit":{
"type":"integer",
"format":"int32"
},
"offset":{
"type":"integer",
"format":"int32"
}
}
},
"QueryManagementRequestDTO":{
"type":"object",
"properties":{
"paginationParam":{
"$ref":"#/components/schemas/PaginationParamDTO"
},
"lastUpdated":{
"type":"string"
},
"queryType":{
"type":"string"
},
"assignedRoleId":{
"type":"string"
},
"subjectIdList":{
"type":"array",
"items":{
"type":"string"
}
},
"siteIdList":{
"type":"array",
"items":{
"type":"string"
}
},
"searchStr":{
"type":"string"
},
"queryGridView":{
"type":"string"
},
"queryCreatedBy":{
"type":"string"
},
"queryByID":{
"type":"string"
},
"queryByAge":{
"type":"string"
},
"queryClosedBy":{
"type":"string"
},
"creatorStudyRoleId":{
"type":"string"
},
"closedStudyRoleId":{
"type":"string"
},
"formIdList":{
"type":"array",
"items":{
"type":"string"
}
},
"visitIdList":{
"type":"array",
"items":{
"type":"string"
}
},
"queryState":{
"type":"array",
"items":{
"type":"string"
}
},
"currentRecord":{
"type":"string"
},
"ruleTypeId":{
"type":"string"
},
"isToDo":{
"type":"boolean"
}
},
"description":"Compared to v1.0, this v2.0 request adds role-based filters, rule type selection, and pagination guards so query management lists can be retrieved with a single call.",
"example":"{\\n \\\"paginationParam\\\": {\\n \\\"offset\\\": 0,\\n \\\"limit\\\": 25,\\n \\\"orderasc\\\": false\\n },\\n \\\"queryState\\\": [\\\"Answered\\\", \\\"Candidate\\\", \\\"Opened\\\"],\\n \\\"currentRecord\\\": \\\"1\\\",\\n \\\"subjectIdList\\\": [\\\"C7A97B54EB144646A5E9322A81C42C2F\\\", \\\"762744769B0E4E40B6A74691179BC578\\\"],\\n \\\"siteIdList\\\": [\\\"CB9BBB0767114F599FE75616223D6665\\\"],\\n \\\"queryByAge\\\": \\\"-7\\\",\\n \\\"queryType\\\": \\\"All\\\",\\n \\\"formIdList\\\": [],\\n \\\"visitIdList\\\": []\\n}"
},
"Query DTO":{
"required":[
"studyRoles"
],
"type":"object",
"properties":{
"studyRoles":{
"type":"array",
"description":"List of study role identifiers to assign. Provide between 1 and 50 values.",
"example":[
"6AF54DB79B764662B685D68C52AB0B84",
"9F8435D105BD49CC9A31DF94A2AF1F01"
],
"items":{
"type":"string",
"description":"List of study role identifiers to assign. Provide between 1 and 50 values.",
"format":"uuid"
}
}
},
"description":"Request for assignupdate Query API",
"example":"{\\n \\\"studyRoles\\\": [\\\"6AF54DB79B764662B685D68C52AB0B84\\\", \\\"9F8435D105BD49CC9A31DF94A2AF1F01\\\"]\\n}"
},
"Field":{
"required":[
"fieldName",
"fieldType",
"fieldValueList"
],
"type":"object",
"properties":{
"fieldName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Field name to evaluate. Examples include STUDYID, SITEID, ruleState, and dateRange.",
"example":"ruleState"
},
"fieldType":{
"maxLength":16,
"minLength":4,
"type":"string",
"description":"Field value classification. Use list for enumerations, date for calendar values, date-time for timestamps, number for numeric filters, string for textual filters, or boolean for true/false.",
"example":"list",
"enum":[
"list",
"date",
"date-time",
"number",
"string",
"boolean"
]
},
"fieldSequence":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"Sequence/order of the field. Provide a non-negative integer.",
"format":"int32",
"example":1
},
"fieldValueList":{
"type":"array",
"description":"List of values for the Field. Provide GUIDs for identifier filters or literal values for textual filters.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"maxLength":256,
"minLength":1,
"type":"string",
"example":"publish"
}
}
},
"description":"Generic representation of a report filter. Each entry specifies the field to evaluate, its data type, and the values to use when filtering.",
"example":{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved"
]
}
},
"SearchSpecs":{
"title":"SearchSpecs",
"type":"object",
"properties":{
"limit":{
"maximum":5000,
"minimum":1,
"type":"integer",
"description":"Maximum number of records to display per page. Provide a value between 1 and 5000 inclusive. Negative numbers are not accepted.",
"format":"int32",
"example":50
},
"offset":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter. Provide a zero or positive value.",
"format":"int32",
"example":5
},
"fieldSpecsList":{
"type":"array",
"description":"Field Specification List. Each element describes a single filter applied to the report.",
"example":[
{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved"
]
}
],
"items":{
"$ref":"#/components/schemas/Field"
}
}
},
"description":"Request body passing search specs like limit, offset and list of fields"
},
"QueryDetailsParamDTO":{
"type":"object",
"properties":{
"paginationParam":{
"$ref":"#/components/schemas/PaginationParamDTO"
},
"subjectId":{
"type":"string"
},
"siteId":{
"type":"string"
},
"visitId":{
"type":"string"
},
"eventId":{
"type":"string"
},
"formId":{
"type":"string"
},
"dataElementId":{
"type":"string"
},
"states":{
"uniqueItems":true,
"type":"array",
"items":{
"type":"string"
}
},
"eventInstanceNumber":{
"type":"string"
},
"formInstanceNumber":{
"type":"string"
},
"itemId":{
"type":"string"
},
"currentRecord":{
"type":"string"
},
"repeatFormNumber":{
"type":"integer",
"description":"Repeat form sequence number. Negative values are rejected.",
"format":"int64",
"example":1
},
"propertyType":{
"type":"string"
},
"propertyName":{
"maxLength":256,
"minLength":1,
"type":"string"
},
"studyRoles":{
"type":"array",
"description":"List of study role identifiers applied to the query.",
"items":{
"type":"string",
"format":"uuid"
}
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy identifier. Negative values are rejected.",
"format":"int64",
"example":123456789
}
}
},
"QueryDTOv9Response":{
"title":"QueryDTO Version 9",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query unique identifier. Value must be a 32 to 36 character hexadecimal GUID.",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments captured during open, candidate, or close operations.",
"example":"Query comment example here.."
},
"state":{
"type":"string",
"description":"Query state. Allowed values: Candidate (new discrepancy awaiting triage), Opened (active discrepancy requiring action), Answered (site responded awaiting review), Closed (resolved discrepancy), Deleted (removed during workflow).",
"example":"Opened",
"enum":[
"Candidate",
"Opened",
"Answered",
"Closed",
"Deleted"
]
},
"subjectId":{
"type":"string",
"description":"Subject unique GUID.",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element unique GUID.",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element version start timestamp in ISO-8601 format.",
"format":"date-time",
"example":"2026-01-15T10:05:30Z"
},
"formId":{
"type":"string",
"description":"Form unique GUID.",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating form. Negative values are rejected.",
"format":"int64",
"example":0
},
"siteId":{
"type":"string",
"description":"Site unique GUID.",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event unique GUID.",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating event. Negative values are rejected.",
"format":"int64",
"example":0
},
"studyRoles":{
"type":"array",
"description":"Study role assignments returned after update.",
"items":{
"$ref":"#/components/schemas/QueryStudyRoleDTOv6"
}
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy identifier sourced from Data Capture. Negative values are rejected.",
"format":"int64",
"example":123456789
},
"repeatFormNumber":{
"type":"integer",
"description":"Repeat form sequence number. Negative values are rejected.",
"format":"int64",
"example":1
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object version. Negative values are rejected.",
"format":"int64",
"example":0
},
"itemId":{
"type":"string",
"description":"Item unique GUID.",
"format":"uuid"
},
"propertyName":{
"type":"string",
"description":"Property name associated with the query when Data Capture properties are involved. Example: visit.",
"example":"visit"
},
"propertyType":{
"type":"string",
"description":"Property type classification. Allowed values: visit (query anchored to visit details), visitStartDate (query anchored to the visit start date).",
"example":"visit",
"enum":[
"visit",
"visitStartDate"
]
},
"ruleId":{
"type":"string",
"description":"Rule unique GUID for queries created by rule.",
"format":"uuid"
},
"isQueryCreator":{
"type":"boolean",
"description":"Indicates if the authenticated user created the query (true or false).",
"example":true
}
},
"description":"Information returned from updating/inserting query",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 6,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"discrepancyId\\\": 123456789,\\n \\\"repeatFormNumber\\\": 1,\\n \\\"propertyName\\\": \\\"visit\\\",\\n \\\"propertyType\\\": \\\"visitStartDate\\\",\\n \\\"ruleId\\\": \\\"0E1F4EDBB97943F0B2DE8C6C5AA31234\\\",\\n \\\"isQueryCreator\\\": true,\\n \\\"studyRoles\\\": [{\\\"studyRoleId\\\": \\\"6AF54DB79B764662B685D68C52AB0B84\\\", \\\"studyRoleName\\\": \\\"CRA\\\"}]\\n}"
},
"QueryStudyRoleDTOv6":{
"type":"object",
"properties":{
"studyRoleId":{
"type":"string",
"description":"Study role of the user performing the query operation",
"format":"uuid"
},
"studyRoleName":{
"type":"string",
"description":"Study role name of the user performing the query operation",
"example":"CRA"
}
}
},
"QueryAssignUpdateRequest":{
"required":[
"studyRoles"
],
"type":"object",
"properties":{
"studyRoles":{
"type":"array",
"description":"List of study role identifiers to assign.",
"example":[
"6AF54DB79B764662B685D68C52AB0B84"
],
"items":{
"type":"string",
"format":"uuid"
}
},
"comment":{
"type":"string",
"description":"Review comment recorded during assignment.",
"example":"Reassigning to CRA for follow-up."
}
},
"description":"Request payload for query assign update v10 API."
},
"QueryDTOv9":{
"title":"QueryDTO Version 9",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query unique identifier. Value must be a 32 to 36 character hexadecimal GUID.",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments captured during open, candidate, or close operations.",
"example":"Query comment example here.."
},
"subjectId":{
"type":"string",
"description":"Subject unique GUID.",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element unique GUID.",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element version start timestamp in ISO-8601 format.",
"format":"date-time",
"example":"2026-01-15T10:05:30Z"
},
"formId":{
"type":"string",
"description":"Form unique GUID.",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating form. Negative values are rejected.",
"format":"int64",
"example":0
},
"siteId":{
"type":"string",
"description":"Site unique GUID.",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event unique GUID.",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating event. Negative values are rejected.",
"format":"int64",
"example":0
},
"studyRoles":{
"type":"array",
"description":"List of study role identifiers assigned to the query.",
"example":[
"6AF54DB79B764662B685D68C52AB0B84",
"6AF54DB79B764662B685D68C52AB0B84"
],
"items":{
"type":"string",
"format":"uuid"
}
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy identifier sourced from Data Capture. Negative values are rejected.",
"format":"int64",
"example":123456789
},
"repeatFormNumber":{
"type":"integer",
"description":"Repeat form sequence number. Negative values are rejected.",
"format":"int64",
"example":1
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object version. Negative values are rejected.",
"format":"int64",
"example":0
},
"itemId":{
"type":"string",
"description":"Item unique GUID.",
"format":"uuid"
},
"propertyName":{
"type":"string",
"description":"Property name associated with the query when Data Capture properties are involved. Example: visit.",
"example":"visit"
},
"propertyType":{
"type":"string",
"description":"Property type classification. Allowed values: visit (query anchored to visit details), visitStartDate (query anchored to the visit start date).",
"example":"visit",
"enum":[
"visit",
"visitStartDate"
]
},
"userDisplayName":{
"type":"string",
"description":"First and last name of the query creator or last modifier.",
"example":"John Doe"
}
},
"description":"Information for creating/editing query",
"example":"{\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"studyRoles\\\": [\\\"6AF54DB79B764662B685D68C52AB0B84\\\"],\\n \\\"discrepancyId\\\": 123456789,\\n \\\"propertyName\\\": \\\"visit\\\",\\n \\\"propertyType\\\": \\\"visitStartDate\\\",\\n \\\"userDisplayName\\\": \\\"Jane QueryAuthor\\\"\\n}"
},
"QueryCountResults":{
"title":"QueryCountResults v2.0",
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Operation status. Allowed values: success, failed.",
"example":"success"
},
"version":{
"type":"string",
"description":"Schema version of the response wrapper.",
"example":"2"
},
"errorData":{
"type":"string",
"description":"Optional error payload when status is failed.",
"example":"null"
},
"result":{
"type":"array",
"description":"Query count detail rows",
"items":{
"$ref":"#/components/schemas/QueryCountResults Entry"
}
}
},
"description":"Query Count result payload",
"example":{
"status":"success",
"version":"2",
"errorData":null,
"result":[
{
"subjectName":"TestSite1184",
"subjectId":"762744769B0E4E40B6A74691179BC578",
"eventId":"3B95322B15144E4397B30305EB33E871",
"eventInstanceNumber":null,
"candidate":0,
"opened":1,
"answered":0,
"deleted":0,
"closed":0,
"totalQueries":1
}
]
}
},
"QueryCountResults Entry":{
"title":"QueryCountResults Entry v2.0",
"type":"object",
"properties":{
"subjectName":{
"type":"string",
"description":"Subject display name",
"example":"TestSite1184"
},
"subjectId":{
"type":"string",
"description":"Subject unique identifier",
"example":"762744769B0E4E40B6A74691179BC578"
},
"eventId":{
"type":"string",
"description":"Event unique identifier",
"example":"3B95322B15144E4397B30305EB33E871"
},
"eventInstanceNumber":{
"type":"integer",
"description":"Event instance (repeat) number",
"format":"int32",
"example":1
},
"answered":{
"type":"integer",
"description":"Answered query count for the subject/event combination",
"format":"int32",
"example":0
},
"candidate":{
"type":"integer",
"description":"Candidate query count for the subject/event combination",
"format":"int32",
"example":0
},
"opened":{
"type":"integer",
"description":"Open query count for the subject/event combination",
"format":"int32",
"example":1
},
"deleted":{
"type":"integer",
"description":"Deleted query count for the subject/event combination",
"format":"int32",
"example":0
},
"closed":{
"type":"integer",
"description":"Closed query count for the subject/event combination",
"format":"int32",
"example":0
},
"totalQueries":{
"type":"integer",
"description":"Total queries for the provided state filters",
"format":"int32",
"example":1
}
},
"description":"Query Count result payload entry",
"example":{
"subjectName":"TestSite1184",
"subjectId":"762744769B0E4E40B6A74691179BC578",
"eventId":"3B95322B15144E4397B30305EB33E871",
"eventInstanceNumber":null,
"candidate":0,
"opened":1,
"answered":0,
"deleted":0,
"closed":0,
"totalQueries":1
}
},
"OpenQueryCountPostDTO":{
"title":"OpenQueryCountPostDTO v2.0",
"required":[
"subjects"
],
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subject identifiers to evaluate.",
"example":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
],
"items":{
"type":"string",
"description":"List of subject identifiers to evaluate.",
"format":"uuid"
}
}
},
"description":"Open query count request payload."
},
"QueryCountPostDTO":{
"title":"QueryCountPostDTO v2.0",
"required":[
"states",
"subjects"
],
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subject identifiers to evaluate.",
"example":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
],
"items":{
"type":"string",
"description":"List of subject identifiers to evaluate.",
"format":"uuid"
}
},
"states":{
"uniqueItems":true,
"type":"array",
"description":"List of query states to include in the count. Allowed values: Candidate, Opened, Answered, Deleted, Closed.",
"example":[
"Opened",
"Answered",
"Candidate"
],
"items":{
"type":"string",
"description":"List of query states to include in the count. Allowed values: Candidate, Opened, Answered, Deleted, Closed.",
"example":"[\"Opened\",\"Answered\",\"Candidate\"]"
}
}
},
"description":"Query count request payload."
},
"QueryDTOv2":{
"title":"QueryDTO Version 2",
"required":[
"dataElementId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query unique GUID generated by the service.",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments.",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state. Candidate = query created but not yet opened; Opened = action required; Answered = awaiting review; Deleted = removed from workflow; Closed = finalised.",
"example":"Opened",
"enum":[
"Candidate",
"Opened",
"Answered",
"Deleted",
"Closed"
]
},
"subjectId":{
"type":"string",
"description":"Subject unique GUID.",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element unique GUID.",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element version start timestamp.",
"format":"date-time",
"example":"2026-01-15T10:05:30Z"
},
"formId":{
"type":"string",
"description":"Form unique GUID.",
"format":"uuid"
},
"siteId":{
"type":"string",
"description":"Site unique GUID.",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event unique GUID.",
"format":"uuid"
},
"eventInstanceNumber":{
"minimum":0,
"exclusiveMinimum":false,
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating event. Negative values are rejected.",
"format":"bigdecimal",
"example":0
}
},
"description":"Information for creating/editing query",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0\\n}"
},
"QueryDTOv3":{
"title":"QueryDTO Version 3",
"required":[
"dataElementId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state",
"example":"Opened"
},
"subjectId":{
"type":"string",
"description":"Subject Unique GUID",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element Unique GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element Version Start",
"format":"date-time"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"siteId":{
"type":"string",
"description":"Site Unique GUID",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event Unique GUID",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating event",
"example":0
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating form",
"example":0
}
},
"description":"Information for creating/editing query",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0\\n}"
},
"QueryTabDTOV3":{
"title":"QueryTabDTO Version 3",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"Timestamp when this version of the query became active.",
"format":"date-time",
"example":"2024-04-02T17:33:03.958Z"
},
"versionEnd":{
"type":"string",
"description":"Timestamp when this version of the query ended. Null indicates the version is current.",
"format":"date-time",
"example":"2024-04-02T17:35:13.333Z"
},
"ruleId":{
"type":"string",
"description":"Rule unique GUID.",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments supplied by the responder.",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state. Candidate = query created but not yet opened; Opened = action required; Answered = awaiting review; Deleted = removed from workflow; Closed = finalised.",
"example":"Opened",
"enum":[
"Candidate",
"Opened",
"Answered",
"Deleted",
"Closed"
]
},
"subjectId":{
"type":"string",
"description":"Subject unique GUID.",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element unique GUID.",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element version start date-time.",
"format":"date-time",
"example":"2024-04-02T17:33:03.958Z"
},
"formId":{
"type":"string",
"description":"Form unique GUID.",
"format":"uuid"
},
"siteId":{
"type":"string",
"description":"Site unique GUID.",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event unique GUID.",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating form. Negative values are rejected.",
"format":"bigdecimal",
"example":0
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object version number. Negative values are rejected.",
"format":"bigdecimal",
"example":0
},
"itemId":{
"type":"string",
"description":"Item unique GUID.",
"format":"uuid"
},
"operationType":{
"type":"string",
"description":"Operation type applied to the record. CREATED = new record inserted; UPDATED = record changed; REMOVED = record deleted or inactivated.",
"example":"CREATED",
"enum":[
"CREATED",
"UPDATED",
"REMOVED"
]
},
"reason":{
"type":"string",
"description":"Reason provided for the last operation.",
"example":"Study roles assignment change"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating event. Negative values are rejected.",
"format":"bigdecimal",
"example":0
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number used when the record was stored. Negative values are rejected.",
"format":"bigdecimal",
"example":1
},
"subjectNumber":{
"type":"string",
"description":"Study subject number.",
"example":"site12"
},
"comment":{
"type":"string",
"description":"Additional comment about the operation.",
"example":"site12"
},
"userId":{
"type":"string",
"description":"User unique GUID.",
"format":"uuid"
},
"branchId":{
"type":"string",
"description":"Branch unique GUID.",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"description":"Study role unique GUID.",
"format":"uuid"
},
"creatorStudyRoleId":{
"type":"string",
"description":"Creator study role unique GUID.",
"format":"uuid"
},
"repeatFormNumber":{
"type":"integer",
"description":"Repeat form number. Negative values are rejected.",
"format":"int64",
"example":0
},
"discrepancyId":{
"type":"integer",
"description":"Unique discrepancy identifier. Negative values are rejected.",
"format":"int64",
"example":123456789
},
"propertyType":{
"type":"string",
"description":"Property Type of Query",
"example":"visit"
},
"propertyName":{
"type":"string",
"description":"Property Name of Query",
"example":"visitStartDate"
},
"userName":{
"type":"string",
"description":"User Name for the Query operation",
"example":"system"
}
},
"description":"Table of query information"
},
"QueryDTOv4":{
"title":"QueryDTO Version 4",
"required":[
"dataElementId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID generated by the service.",
"format":"uuid"
},
"queryComment":{
"type":"string",
"description":"Query comments provided when updating the query.",
"example":"Reopening query after data correction."
},
"state":{
"type":"string",
"description":"Query state. Candidate = query created but not yet opened; Opened = action required; Answered = awaiting review; Closed = resolved; Deleted = removed from workflow.",
"example":"Opened",
"enum":[
"Candidate",
"Opened",
"Answered",
"Closed",
"Deleted"
]
},
"subjectId":{
"type":"string",
"description":"Subject Unique GUID",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element Unique GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element version start timestamp in ISO-8601 format.",
"format":"date-time",
"example":"2026-01-15T10:05:30Z"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"siteId":{
"type":"string",
"description":"Site Unique GUID",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event Unique GUID",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating event. Negative values are rejected.",
"format":"bigdecimal",
"example":0
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating form. Negative values are rejected.",
"format":"bigdecimal",
"example":0
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the object version number used for optimistic locking. Negative values are rejected.",
"format":"bigdecimal",
"example":1
}
},
"description":"Information for creating/editing query",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 1\\n}"
},
"QueryDTOv5":{
"title":"QueryDTO Version 5",
"required":[
"dataElementId",
"eventId",
"formId",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query unique identifier generated by the service.",
"format":"uuid"
},
"queryComment":{
"type":"string",
"description":"Query comment captured when creating or updating the query.",
"example":"Query reopened after visit start date correction."
},
"state":{
"type":"string",
"description":"Query state. Candidate = query created but not yet opened; Opened = active action required; Answered = site responded; Closed = sponsor closed; Deleted = removed from workflow.",
"example":"Opened",
"enum":[
"Candidate",
"Opened",
"Answered",
"Closed",
"Deleted"
]
},
"subjectId":{
"type":"string",
"description":"Subject unique identifier associated with the query.",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element unique identifier.",
"format":"uuid"
},
"dataElementVersionStart":{
"type":"string",
"description":"Timestamp when the referenced data element version started (ISO-8601).",
"format":"date-time",
"example":"2026-01-15T10:05:30Z"
},
"formId":{
"type":"string",
"description":"Form unique identifier.",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Repeat sequence number (0, 1, 2, ...) of the form. Negative values are rejected.",
"format":"int64",
"example":0
},
"siteId":{
"type":"string",
"description":"Site unique identifier that owns the subject.",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event unique identifier for the visit.",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Repeat sequence number (0, 1, 2, ...) of the visit. Negative values are rejected.",
"format":"int64",
"example":0
},
"objectVersionNumber":{
"type":"number",
"description":"Optimistic locking number (0, 1, 2, ...) maintained by the service. Negative values are rejected.",
"format":"int64",
"example":2
},
"itemId":{
"type":"string",
"description":"Item unique identifier referenced by the query.",
"format":"uuid"
},
"propertyType":{
"type":"string",
"description":"Property classification associated with the query. visit = visit-level property metadata returned by validation rules.",
"example":"visit",
"enum":[
"visit"
]
},
"propertyName":{
"type":"string",
"description":"Specific property name derived from the propertyType. visitStartDate = captured visit start date discrepancy.",
"example":"visitStartDate"
}
},
"description":"Information for creating or updating a manual query in v5.0. Compared to v4.0, this schema preserves propertyType/propertyName metadata produced by validation rules.",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 2,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"propertyType\\\": \\\"visit\\\",\\n \\\"propertyName\\\": \\\"visitStartDate\\\"\\n}"
},
"CommentDetailsDTO":{
"type":"object",
"properties":{
"state":{
"type":"string",
"description":"Query state for the comment entry. Candidate = query created but not yet opened; Opened = action required; Answered = awaiting review; Closed = resolved; Deleted = removed from workflow.",
"example":"Opened",
"enum":[
"Candidate",
"Opened",
"Answered",
"Closed",
"Deleted"
]
},
"queryComment":{
"type":"string",
"description":"Comment text recorded for the query state transition.",
"example":"Query remains open pending site response."
},
"versionStart":{
"type":"string",
"description":"Timestamp when the comment became effective.",
"format":"date-time",
"example":"2024-03-14T09:15:30Z"
},
"value":{
"type":"string",
"description":"Optional value associated with the comment.",
"example":"Visit data validated."
},
"userInfo":{
"$ref":"#/components/schemas/DisplayUserDto"
}
},
"description":"A list of comments associated with the query"
},
"DisplayUserDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the user.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"Alice"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Brown"
},
"userName":{
"type":"string",
"description":"User's login name.",
"example":"alicebrown"
},
"emailAddress":{
"type":"string",
"description":"User's email address.",
"example":"alice.brown@email.com"
}
},
"description":"User details including name, username, and email address."
},
"QueryDetailsDTOV6Resp":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"subjectName":{
"type":"string"
},
"visitName":{
"type":"string"
},
"formName":{
"type":"string"
},
"formId":{
"type":"string",
"format":"uuid"
},
"subjectId":{
"type":"string",
"format":"uuid"
},
"visitId":{
"type":"string",
"format":"uuid"
},
"ruleId":{
"type":"string",
"format":"uuid"
},
"studyVersion":{
"type":"string"
},
"itemId":{
"type":"string",
"format":"uuid"
},
"itemName":{
"type":"string"
},
"comments":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CommentDetailsDTO"
}
},
"eventInstanceNumber":{
"type":"integer",
"format":"int32"
},
"formInstanceNumber":{
"type":"integer",
"format":"int32"
},
"studyRoles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/QueryStudyRoleDTOv6"
}
},
"queryModAllowedByUser":{
"type":"boolean"
},
"userCanCloseQuery":{
"type":"boolean"
}
}
},
"QueryDTOv6":{
"title":"QueryDTO Version 6",
"required":[
"eventId",
"formId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state",
"example":"Opened"
},
"subjectId":{
"type":"string",
"description":"Subject Unique GUID",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element Unique GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element Version Start",
"format":"date-time"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating form",
"example":0
},
"siteId":{
"type":"string",
"description":"Site Unique GUID",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event Unique GUID",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating event",
"example":0
},
"studyRoles":{
"type":"array",
"description":"List of study roles ids",
"example":[
"6AF54DB79B764662B685D68C52AB0B84",
"6AF54DB79B764662B685D68C52AB0B84"
],
"items":{
"type":"string",
"description":"List of study roles ids",
"format":"uuid"
}
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object Version Number",
"example":0
},
"itemId":{
"type":"string",
"description":"Item Unique GUID",
"format":"uuid"
}
},
"description":"Information for creating/editing query",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 3,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"studyRoles\\\": [\\\"6AF54DB79B764662B685D68C52AB0B84\\\"]\\n}"
},
"QueryDTOv7":{
"title":"QueryDTO Version 7",
"required":[
"eventId",
"formId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state",
"example":"Opened"
},
"subjectId":{
"type":"string",
"description":"Subject Unique GUID",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element Unique GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element Version Start",
"format":"date-time"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating form",
"example":0
},
"siteId":{
"type":"string",
"description":"Site Unique GUID",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event Unique GUID",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating event",
"example":0
},
"studyRoles":{
"type":"array",
"description":"List of study roles ids",
"example":[
"6AF54DB79B764662B685D68C52AB0B84",
"6AF54DB79B764662B685D68C52AB0B84"
],
"items":{
"type":"string",
"description":"List of study roles ids",
"format":"uuid"
}
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy Id",
"format":"int64",
"example":123456789
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object Version Number",
"example":0
},
"itemId":{
"type":"string",
"description":"Item Unique GUID",
"format":"uuid"
}
},
"description":"Information for creating/editing query",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 4,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"studyRoles\\\": [\\\"6AF54DB79B764662B685D68C52AB0B84\\\"],\\n \\\"discrepancyId\\\": 123456789\\n}"
},
"QueryDTOv6Resp":{
"required":[
"eventId",
"formId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state",
"example":"Opened"
},
"subjectId":{
"type":"string",
"description":"Subject Unique GUID",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element Unique GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element Version Start",
"format":"date-time"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating form",
"example":0
},
"siteId":{
"type":"string",
"description":"Site Unique GUID",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event Unique GUID",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating event",
"example":0
},
"studyRoles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/QueryStudyRoleDTOv6"
}
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object Version Number",
"example":0
},
"itemId":{
"type":"string",
"description":"Item Unique GUID",
"format":"uuid"
},
"creatorStudyRoleId":{
"type":"string",
"format":"uuid"
},
"isQueryCreator":{
"type":"boolean"
}
},
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 3,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"studyRoles\\\": [{\\\"studyRoleId\\\": \\\"6AF54DB79B764662B685D68C52AB0B84\\\", \\\"studyRoleName\\\": \\\"CRA\\\"}],\\n \\\"creatorStudyRoleId\\\": \\\"9F8435D105BD49CC9A31DF94A2AF1F01\\\",\\n \\\"isQueryCreator\\\": true\\n}"
},
"QueryDetailsDTOv7Resp":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"subjectName":{
"type":"string"
},
"visitName":{
"type":"string"
},
"formName":{
"type":"string"
},
"formId":{
"type":"string",
"format":"uuid"
},
"subjectId":{
"type":"string",
"format":"uuid"
},
"visitId":{
"type":"string",
"format":"uuid"
},
"ruleId":{
"type":"string",
"format":"uuid"
},
"studyVersion":{
"type":"string"
},
"itemId":{
"type":"string",
"format":"uuid"
},
"itemName":{
"type":"string"
},
"comments":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CommentDetailsDTO"
}
},
"eventInstanceNumber":{
"type":"integer",
"format":"int32"
},
"formInstanceNumber":{
"type":"integer",
"format":"int32"
},
"studyRoles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/QueryStudyRoleDTOv6"
}
},
"queryModAllowedByUser":{
"type":"boolean"
},
"userCanCloseQuery":{
"type":"boolean"
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy Id",
"format":"int64",
"example":123456789
},
"objectVersionNumber":{
"type":"number"
},
"userCanAnswerQuery":{
"type":"boolean"
}
}
},
"QueryDTOv7Resp":{
"required":[
"eventId",
"formId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state",
"example":"Opened"
},
"subjectId":{
"type":"string",
"description":"Subject Unique GUID",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element Unique GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element Version Start",
"format":"date-time"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating form",
"example":0
},
"siteId":{
"type":"string",
"description":"Site Unique GUID",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event Unique GUID",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating event",
"example":0
},
"studyRoles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/QueryStudyRoleDTOv6"
}
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy Id",
"format":"int64",
"example":123456789
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object Version Number",
"example":0
},
"itemId":{
"type":"string",
"description":"Item Unique GUID",
"format":"uuid"
},
"creatorStudyRoleId":{
"type":"string",
"format":"uuid"
},
"isQueryCreator":{
"type":"boolean"
}
},
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 4,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"studyRoles\\\": [{\\\"studyRoleId\\\": \\\"6AF54DB79B764662B685D68C52AB0B84\\\", \\\"studyRoleName\\\": \\\"CRA\\\"}],\\n \\\"discrepancyId\\\": 123456789\\n}"
},
"QueryDetailsDTOv8Resp":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"subjectName":{
"type":"string"
},
"visitName":{
"type":"string"
},
"formName":{
"type":"string"
},
"formId":{
"type":"string",
"format":"uuid"
},
"subjectId":{
"type":"string",
"format":"uuid"
},
"visitId":{
"type":"string",
"format":"uuid"
},
"ruleId":{
"type":"string",
"format":"uuid"
},
"studyVersion":{
"type":"string"
},
"itemId":{
"type":"string",
"format":"uuid"
},
"itemName":{
"type":"string"
},
"comments":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CommentDetailsDTO"
}
},
"eventInstanceNumber":{
"type":"integer",
"format":"int32"
},
"formInstanceNumber":{
"type":"integer",
"format":"int32"
},
"studyRoles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/QueryStudyRoleDTOv6"
}
},
"queryModAllowedByUser":{
"type":"boolean"
},
"userCanCloseQuery":{
"type":"boolean"
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy Id",
"format":"int64",
"example":123456789
},
"objectVersionNumber":{
"type":"number"
},
"userCanAnswerQuery":{
"type":"boolean"
},
"repeatFormNumber":{
"type":"integer"
}
}
},
"QueryDTOv8":{
"title":"QueryDTO Version 8",
"required":[
"eventId",
"formId",
"queryComment",
"subjectId"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query Unique GUID",
"format":"uuid"
},
"queryComment":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Query comments",
"example":"Comment"
},
"state":{
"type":"string",
"description":"Query state",
"example":"Opened"
},
"subjectId":{
"type":"string",
"description":"Subject Unique GUID",
"format":"uuid"
},
"dataElementId":{
"type":"string",
"description":"Data element Unique GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Data element Version Start",
"format":"date-time"
},
"formId":{
"type":"string",
"description":"Form Unique GUID",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating form",
"example":0
},
"siteId":{
"type":"string",
"description":"Site Unique GUID",
"format":"uuid"
},
"eventId":{
"type":"string",
"description":"Event Unique GUID",
"format":"uuid"
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of repeating event",
"example":0
},
"studyRoles":{
"type":"array",
"description":"List of study roles ids",
"example":[
"6AF54DB79B764662B685D68C52AB0B84",
"6AF54DB79B764662B685D68C52AB0B84"
],
"items":{
"type":"string",
"description":"List of study roles ids",
"format":"uuid"
}
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy Id",
"format":"int64",
"example":123456789
},
"repeatFormNumber":{
"type":"integer",
"description":"Repeat Form Number"
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object Version Number",
"example":0
},
"itemId":{
"type":"string",
"description":"Item Unique GUID",
"format":"uuid"
}
},
"description":"Information for creating/editing query",
"example":"{\\n \\\"id\\\": \\\"AE33A9096BF548BBB29A96E399E9FBBB\\\",\\n \\\"queryComment\\\": \\\"Visit date clarification required.\\\",\\n \\\"state\\\": \\\"Opened\\\",\\n \\\"subjectId\\\": \\\"762744769B0E4E40B6A74691179BC578\\\",\\n \\\"dataElementId\\\": \\\"583A45DD0A1C46F88D7842D76CAF9A59\\\",\\n \\\"dataElementVersionStart\\\": \\\"2026-01-15T10:05:30Z\\\",\\n \\\"formId\\\": \\\"680E0FB01F1B4CCB990C333563FAEE80\\\",\\n \\\"siteId\\\": \\\"CB9BBB0767114F599FE75616223D6665\\\",\\n \\\"eventId\\\": \\\"3B95322B15144E4397B30305EB33E871\\\",\\n \\\"eventInstanceNumber\\\": 0,\\n \\\"formInstanceNumber\\\": 0,\\n \\\"objectVersionNumber\\\": 5,\\n \\\"itemId\\\": \\\"42738D18833E45C29D9CDEABBB2247FE\\\",\\n \\\"studyRoles\\\": [\\\"6AF54DB79B764662B685D68C52AB0B84\\\"],\\n \\\"discrepancyId\\\": 123456789,\\n \\\"repeatFormNumber\\\": 1\\n}"
},
"QueryDetailsDTOv9Resp":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Query unique identifier. Value must be a 32 to 36 character hexadecimal GUID.",
"format":"uuid"
},
"subjectId":{
"type":"string",
"description":"Subject unique GUID.",
"format":"uuid"
},
"formId":{
"type":"string",
"description":"Form unique GUID.",
"format":"uuid"
},
"formInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating form. Negative values are rejected.",
"format":"int64",
"example":0
},
"eventInstanceNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of the repeating event. Negative values are rejected.",
"format":"int64",
"example":0
},
"studyRoles":{
"type":"array",
"description":"Study role assignments returned after update.",
"items":{
"$ref":"#/components/schemas/QueryStudyRoleDTOv6"
}
},
"discrepancyId":{
"type":"integer",
"description":"Discrepancy identifier sourced from Data Capture. Negative values are rejected.",
"format":"int64",
"example":123456789
},
"repeatFormNumber":{
"type":"integer",
"description":"Repeat form sequence number. Negative values are rejected.",
"format":"int64",
"example":1
},
"objectVersionNumber":{
"type":"number",
"description":"Sequence number (0, 1, 2, ...) of object version. Negative values are rejected.",
"format":"int64",
"example":0
},
"itemId":{
"type":"string",
"description":"Item unique GUID.",
"format":"uuid"
},
"propertyName":{
"type":"string",
"description":"The name of the property associated with the query",
"example":"visitStartDatev"
},
"propertyType":{
"type":"string",
"description":"The type of property associated with the query",
"example":"visit"
},
"ruleId":{
"type":"string",
"description":"The ID of the rule associated with the query",
"format":"uuid"
},
"isQueryCreator":{
"type":"boolean",
"description":"Indicates if the authenticated user created the query (true or false).",
"example":true
},
"subjectName":{
"type":"string",
"description":"The name of the subject associated with the query",
"example":"John Doe"
},
"visitName":{
"type":"string",
"description":"The name of the visit associated with the query",
"example":"Visit 1"
},
"formName":{
"type":"string",
"description":"The name of the form associated with the query",
"example":"Form 1"
},
"visitId":{
"type":"string",
"description":"The ID of the visit associated with the query",
"format":"uuid",
"example":"123e4567-e89b-12d3-a456-426655440000"
},
"studyVersion":{
"type":"string",
"description":"The version of the study associated with the query",
"example":"1.0"
},
"itemName":{
"type":"string",
"description":"The name of the item associated with the query",
"example":"Item 1"
},
"comments":{
"type":"array",
"description":"A list of comments associated with the query",
"items":{
"$ref":"#/components/schemas/CommentDetailsDTO"
}
},
"queryModAllowedByUser":{
"type":"boolean",
"description":"Indicates whether the user is allowed to modify the query",
"example":true
},
"userCanCloseQuery":{
"type":"boolean",
"description":"Indicates whether the user can close the query",
"example":true
},
"userCanAnswerQuery":{
"type":"boolean",
"description":"Indicates whether the user can answer the query",
"example":true
}
}
},
"RTIntDetailsDto":{
"type":"object",
"properties":{
"jobId":{
"type":"string",
"description":"Identifier of the job responsible for processing the data sent to Digital Gateway through the web service request"
},
"inputId":{
"type":"string",
"description":"Identifier for the record in the database corresponding to the data being sent, this will be used for tracking purposes only"
},
"realTimeId":{
"type":"string",
"description":"Configuration identifier of the integration in Digital Gateway responsible for processing the data sent through the web service request",
"example":"IbIvrsIntegration"
},
"message":{
"type":"string"
}
}
},
"DGErrorResponseData":{
"type":"object",
"properties":{
"errorCode":{
"type":"string"
},
"errorMessage":{
"type":"string"
},
"details":{
"type":"object"
},
"remediation":{
"type":"string"
},
"studyTitle":{
"type":"string"
},
"siteId":{
"type":"string",
"format":"uuid"
},
"siteName":{
"type":"string"
},
"correlationId":{
"type":"string"
},
"correlationName":{
"type":"string"
}
}
},
"IbIntInputDataDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"inputData":{
"type":"string"
},
"timeQualifier":{
"type":"string",
"format":"date-time"
},
"studyName":{
"type":"string"
},
"integrationType":{
"type":"string"
},
"classifier":{
"type":"string"
},
"inputQualifier":{
"type":"string"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"ibIntegrationType":{
"type":"string",
"description":"Integration types supported by Digital Gateway Builder for real-time integration",
"example":"IbIvrsIntegration",
"enum":[
"IbIvrsIntegration"
]
},
"vendorName":{
"type":"string",
"description":"Name of the Vendor calling this webservice. This value must match with the vendor name used for the integration configured in Digital Gateway"
},
"studyMode":{
"type":"string",
"description":"Mode of the study for which the integration is configured in Digital Gateway"
},
"secretKey":{
"type":"string",
"description":"Name of the secret key configured in the secret store"
},
"userName":{
"type":"string",
"description":"Username corresponding to the secret key"
},
"namespace":{
"type":"string"
}
}
},
"AuthResponse":{
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Indicates request success (\"success\") or failure (\"failure\").",
"format":"none",
"example":"success"
},
"result":{
"type":"object",
"description":"Result data of the API response; actual type depends on the API",
"example":null
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
},
"version":{
"type":"integer",
"description":"Version of the response schema.",
"format":"int32",
"example":1
}
},
"description":"Generic API response wrapper containing result, error data, response version and status."
},
"ModeRightsDto":{
"type":"object",
"properties":{
"mode":{
"type":"string",
"description":"Name of the mode.",
"example":"Test"
},
"rights":{
"uniqueItems":true,
"type":"array",
"description":"Set of authorization rights for the user in this mode.",
"example":[
"CodeListGet",
"StudyDesignReportPost"
],
"items":{
"type":"string",
"description":"Set of authorization rights for the user in this mode.",
"example":"[\"CodeListGet\",\"StudyDesignReportPost\"]"
}
}
},
"description":"Represents a set of rights for a user in a specific study mode.",
"example":{
"mode":"test",
"rights":[
"UpdateRecipe",
"CodeListGet"
]
}
},
"StudyModeRightsDto":{
"type":"object",
"properties":{
"studyid":{
"type":"string",
"description":"Unique study identifier",
"example":"A1B2C3D4E5F67890123456789ABCDEF0"
},
"modeRights":{
"type":"object",
"properties":{
"mode":{
"type":"string",
"description":"Name of the mode.",
"example":"Test"
},
"rights":{
"uniqueItems":true,
"type":"array",
"description":"Set of authorization rights for the user in this mode.",
"example":[
"CodeListGet",
"StudyDesignReportPost"
],
"items":{
"type":"string",
"description":"Set of authorization rights for the user in this mode.",
"example":"[\"CodeListGet\",\"StudyDesignReportPost\"]"
}
}
},
"description":"Represents a set of rights for a user in a specific study mode.",
"example":{
"mode":"test",
"rights":[
"UpdateRecipe",
"CodeListGet"
]
}
}
},
"description":"Represents rights available for a user per study and per mode. Contains the study ID and a list of rights for each available mode for the study."
},
"DepotsListDto":{
"type":"object",
"properties":{
"allDepots":{
"type":"boolean",
"description":"Indicates if the user has access to all depots in the study.",
"example":true
},
"associatedDepots":{
"type":"array",
"description":"A list of UUIDs identifying depots assigned to the user.",
"example":[
"6E697AEB85A24A22B38C70495A0A5C48",
"6E697AEB85A24A22B38C70495A0A5C49"
],
"items":{
"type":"string",
"description":"A list of UUIDs identifying depots assigned to the user.",
"format":"uuid"
}
}
},
"description":"DTO containing the set of depot UUIDs assigned to the user in a study/mode context."
},
"SitesListDto":{
"title":"SitesListDto",
"type":"object",
"properties":{
"allSites":{
"type":"boolean",
"description":"Indicates if the user has access to all sites in the study.",
"example":false
},
"associatedSites":{
"type":"array",
"description":"A list of UUIDs identifying sites assigned to the user.",
"example":[
"6E697AEB85A24A22B38C70495A0A5C48",
"4E9523BF795D4FE4AB9BF1EF8A340FAB"
],
"items":{
"type":"string",
"description":"A list of UUIDs identifying sites assigned to the user.",
"format":"uuid"
}
}
},
"description":"DTO containing the set of site UUIDs assigned to the user in a study/mode context."
},
"StudyAndModesDto":{
"title":"StudyAndModesDto v1.0",
"type":"object",
"properties":{
"studyid":{
"type":"string",
"description":"Unique identifier for the study",
"format":"uuid"
},
"modes":{
"type":"array",
"description":"List of user assignment modes in the study",
"example":[
"active",
"test"
],
"items":{
"type":"string",
"description":"List of user assignment modes in the study",
"example":"[\"active\",\"test\"]"
}
}
},
"description":"Details of a study including the unique UUID and the assignment modes for the user."
},
"UserInfoDto":{
"type":"object",
"properties":{
"firstName":{
"type":"string",
"description":"First name of the user.",
"example":"Alice"
},
"lastName":{
"type":"string",
"description":"Last name of the user.",
"example":"Smith"
},
"emailAddress":{
"type":"string",
"description":"Email address of the user.",
"format":"email",
"example":"alice.smith@example.com"
},
"globalRights":{
"uniqueItems":true,
"type":"array",
"description":"Set of global rights for the user.",
"example":[
"StudyStatePost",
"OrsSiteShipmentPost"
],
"items":{
"type":"string",
"description":"Set of global rights for the user.",
"example":"[\"StudyStatePost\",\"OrsSiteShipmentPost\"]"
}
}
},
"description":"User information (v1): identity and rights."
},
"UserAttributesDto":{
"type":"object",
"properties":{
"key":{
"type":"string",
"description":"The attribute key name",
"example":"Locale"
},
"value":{
"type":"string",
"description":"The value of the attribute",
"example":"en-US"
}
},
"description":"Key-value pair for user attribute",
"example":{
"key":"Locale",
"value":"en-US"
}
},
"UserInfoDtoV3":{
"type":"object",
"properties":{
"firstName":{
"type":"string",
"description":"User's first name",
"example":"Eve"
},
"lastName":{
"type":"string",
"description":"User's last name",
"example":"Johnson"
},
"emailAddress":{
"type":"string",
"description":"User's email address",
"format":"email",
"example":"eve.johnson@example.com"
},
"userId":{
"type":"string",
"description":"User identifier.",
"format":"uuid"
},
"globalRights":{
"uniqueItems":true,
"type":"array",
"description":"Set of user's global rights",
"example":[
"Lab Get",
"Rule Designer"
],
"items":{
"type":"string",
"description":"Set of user's global rights",
"example":"[\"Lab Get\",\"Rule Designer\"]"
}
},
"userAttributes":{
"type":"object",
"properties":{
"key":{
"type":"string",
"description":"The attribute key name",
"example":"Locale"
},
"value":{
"type":"string",
"description":"The value of the attribute",
"example":"en-US"
}
},
"description":"Key-value pair for user attribute",
"example":{
"key":"Locale",
"value":"en-US"
}
}
},
"description":"User information (v3): All user info including attributes and global rights.",
"example":{
"firstName":"Eve",
"lastName":"Johnson",
"emailAddress":"eve.johnson@example.com",
"userId":"EC026DEDC88723C3E053EB944C645812",
"globalRights":[
"UpdateRecipe",
"OrsSiteShipmentPost"
],
"userAttributes":[
{
"key":"Locale",
"value":"en-US"
},
{
"key":"TimeZone",
"value":"Europe/Paris"
}
]
}
},
"DataClassificationStudyLevelDto":{
"required":[
"dataClassificationId",
"dataClassificationName",
"studyRoleId"
],
"type":"object",
"properties":{
"dataClassificationId":{
"type":"string",
"description":"Unique identifier for the Data Classification.",
"example":"C94C507E21544840A8C17B1031305D7E"
},
"dataClassificationName":{
"type":"string",
"description":"Name of the Data Classification.",
"example":"Adjudication Data"
},
"dataClassificationNameLabel":{
"type":"string",
"description":"Localized label for the Data Classification's name.",
"example":"Adjudication Data"
},
"dataClassificationDesc":{
"type":"string",
"description":"Description of the Data Classification.",
"example":"Data findings collected by an adjudicator from adjudication events or safety and efficacy clinical endpoints"
},
"dataClassificationLevel":{
"type":"string",
"description":"List of classification levels (e.g. SITE, DEPOT, STUDY).",
"example":"[\"SITE\",\"DEPOT\"]"
},
"dataClassificationDescLabel":{
"type":"string",
"description":"Localized label for the Data Classification's description.",
"example":"Data findings collected by an adjudicator from adjudication events or safety and efficacy clinical endpoints"
},
"studyRoleId":{
"type":"string",
"description":"Unique identifier for the associated study role.",
"example":"7F4E9071608843F4A9F67B297672B09E"
}
},
"description":"Extends DataClassificationDto to include information about the associated study role for data classification at the study level."
},
"DataClassificationDto":{
"required":[
"dataClassificationId",
"dataClassificationName"
],
"type":"object",
"properties":{
"dataClassificationId":{
"type":"string",
"description":"DataClassification ID",
"format":"uuid"
},
"dataClassificationName":{
"type":"string",
"description":"DataClassification name",
"format":"String",
"example":"Adjudication Data"
},
"dataClassificationNameLabel":{
"type":"string",
"description":"DataClassification translated name",
"format":"String",
"example":"Adjudication Data"
},
"dataClassificationDesc":{
"type":"string",
"description":"DataClassification description",
"format":"String",
"example":"Data findings collected by an adjudicator from adjudication events or safety and efficacy clinical endpoints"
},
"dataClassificationDescLabel":{
"type":"string",
"description":"DataClassification translated description",
"format":"String",
"example":"Data findings collected by an adjudicator from adjudication events or safety and efficacy clinical endpoints"
},
"dataClassificationLevel":{
"title":"dataClassificationLevel",
"type":"string",
"description":"DataClassification levels"
}
}
},
"DataClassificationStudyRolesDto":{
"required":[
"dataClassificationId",
"dataClassificationLevel",
"studyRoleId",
"studyRoleName",
"studyRoleStatus"
],
"type":"object",
"properties":{
"studyRoleId":{
"type":"string",
"description":"Unique identifier for the study role.",
"format":"uuid"
},
"studyRoleName":{
"type":"string",
"description":"Name of the study role.",
"example":"Rule Designer"
},
"studyRoleStatus":{
"type":"string",
"description":"Status of the study role (e.g., ACTIVE, INACTIVE).",
"example":"ACTIVE"
},
"dataClassificationId":{
"type":"string",
"description":"Unique identifier of the data classification object associated with this study role.",
"format":"uuid"
},
"dataClassificationLevel":{
"type":"string",
"description":"Classification levels applied for this role.",
"example":"[\"SITE\",\"DEPOT\"]"
}
},
"description":"Represents a mapping between a study role and its associated data classification including the assigned classification level(s)."
},
"DataClassificationIdsDto":{
"required":[
"dataClassifications"
],
"type":"object",
"properties":{
"dataClassifications":{
"type":"array",
"description":"list of data classifications Unique GUIDs",
"format":"uuid",
"example":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
],
"items":{
"type":"string",
"description":"list of data classifications Unique GUIDs",
"format":"uuid"
}
}
},
"description":"List of DataClassification UUIDs as part of a request payload.",
"example":{
"dataClassifications":[
"938D23FA6B7241CCA41BD627E5DB60DA",
"699EF3745FC545589F186D2198F3C65E"
]
}
},
"DataClassificationIdLevelDto":{
"required":[
"dataClassificationId",
"dataClassificationLevel"
],
"type":"object",
"properties":{
"dataClassificationId":{
"type":"string",
"description":"Unique identifier for the Data Classification.",
"example":"899E66BCE1D8471F96F58A396C416E0D"
},
"dataClassificationLevel":{
"type":"string",
"description":"List of classification levels assigned to the data classification.",
"example":"[\"SITE\",\"DEPOT\"]"
}
},
"description":"DTO for Data Classification with specific levels per classification."
},
"DisplayRightPropertiesDto":{
"required":[
"displayName"
],
"type":"object",
"properties":{
"displayName":{
"type":"string",
"description":"The display name of the right",
"example":"Can view data"
}
},
"description":"DTO describing the properties of a user right assigned to a role.",
"example":{
"displayName":"Can view data"
}
},
"DisplayRoleRightsDto":{
"required":[
"roleCategory",
"roleId",
"roleName"
],
"type":"object",
"properties":{
"roleId":{
"type":"string",
"description":"Unique identifier for the role",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"The display name of the role",
"example":"Data Reviewer"
},
"roleCategory":{
"type":"string",
"description":"Category of the role",
"example":"User"
},
"rights":{
"required":[
"displayName"
],
"type":"object",
"properties":{
"displayName":{
"type":"string",
"description":"The display name of the right",
"example":"Can view data"
}
},
"description":"DTO describing the properties of a user right assigned to a role.",
"example":{
"displayName":"Can view data"
}
}
},
"description":"DTO representing a role and all rights assigned to that role.",
"example":{
"roleId":"2BC29B36F5D64B1B95F4BDBBCEA420BE",
"roleName":"Data Reviewer",
"roleCategory":"User",
"rights":[
{
"rightId":"3DE7AA90C7244F13AAA8002164D88E79",
"rightName":"View Data",
"rightType":"READ",
"granted":true
}
]
}
},
"DisplayCategoryDto":{
"required":[
"category"
],
"type":"object",
"properties":{
"category":{
"type":"string",
"description":"The name of the category grouping rights",
"example":"Data Entry"
},
"rights":{
"required":[
"displayName",
"selected"
],
"type":"object",
"properties":{
"displayName":{
"type":"string",
"description":"Display name of the right",
"example":"Edit Forms"
},
"selected":{
"type":"boolean",
"description":"Indicates if the right is selected (assigned) for this user/role",
"example":true
}
},
"description":"DTO representing a right (permission) and whether it is selected for a user or role.",
"example":{
"displayName":"Edit Forms",
"selected":true
}
}
},
"description":"DTO representing a category grouping of rights for a role.",
"example":{
"category":"Data Entry",
"rights":[
{
"rightId":"A37EA9D55B0B43A1A36657A4094662A3",
"rightName":"Edit Forms",
"rightType":"WRITE",
"granted":true
}
]
}
},
"DisplayRightDto":{
"required":[
"displayName",
"selected"
],
"type":"object",
"properties":{
"displayName":{
"type":"string",
"description":"Display name of the right",
"example":"Edit Forms"
},
"selected":{
"type":"boolean",
"description":"Indicates if the right is selected (assigned) for this user/role",
"example":true
}
},
"description":"DTO representing a right (permission) and whether it is selected for a user or role.",
"example":{
"displayName":"Edit Forms",
"selected":true
}
},
"SDFShortInfo":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the site, depot, or facility (UUID, 32-character uppercase hex as string).",
"example":"9FF4B6B23C864E1F9E9007A8816DBB27"
},
"name":{
"type":"string",
"description":"Human-readable label for the site, depot, or facility entry.",
"example":"Depot Alpha"
}
},
"description":"Short information for a Site/Depot/Facility???used for listing and selection responses. Includes unique id and logical name."
},
"DisplayStudyUserRolesDto":{
"type":"object",
"properties":{
"roleType":{
"type":"string",
"description":"Type or category of the role for the user within a study (such as INVESTIGATOR, VIEWER, etc).",
"example":"design"
},
"roles":{
"type":"array",
"description":"List of role objects (actual schema depends on the use context, typically a DTO representing role details).",
"example":[
{
"roleId":"D0F183DC273340CEA7AFDCB93A5B3D4B",
"roleName":"Assign Site to a Study"
},
{
"roleId":"9ED1AE19B0B04188B8A70A8D8374F315",
"roleName":"View Library Objects"
}
],
"items":{
"type":"object",
"description":"List of role objects (actual schema depends on the use context, typically a DTO representing role details).",
"example":[
{
"roleId":"D0F183DC273340CEA7AFDCB93A5B3D4B",
"roleName":"Assign Site to a Study"
},
{
"roleId":"9ED1AE19B0B04188B8A70A8D8374F315",
"roleName":"View Library Objects"
}
]
}
}
},
"description":"Describes user roles within a study, indicating the type/category and a list of role objects assigned (typically study role details).",
"example":"{\n \"roleType\": \"design\",\n \"roles\": [\n {\n \"roleId\": \"D0F183DC273340CEA7AFDCB93A5B3D4B\",\n \"roleName\": \"Assign Site to a Study\",\n },\n {\n \"roleId\": \"9ED1AE19B0B04188B8A70A8D8374F315\",\n \"roleName\": \"View Library Objects\",\n }\n ]\n}"
},
"RespUserBasicInfo":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"User unique identifier (32-character uppercase hexadecimal UUID).",
"example":"B19DEFBA82754F709E142FB8A13D2120"
},
"firstName":{
"type":"string",
"description":"Given/first name of the user.",
"example":"Divya"
},
"lastName":{
"type":"string",
"description":"Family/last name of the user.",
"example":"Menon"
},
"userName":{
"type":"string",
"description":"Unique system username for login or display.",
"example":"divya.menon"
}
}
},
"DisplayUserListDto":{
"type":"object",
"properties":{
"usersFound":{
"type":"integer",
"description":"The total number of users found matching the query.",
"format":"int32",
"example":2
},
"firstUserReturned":{
"type":"integer",
"description":"Index of the first user returned in this page.",
"format":"int32",
"example":1
},
"usersReturned":{
"type":"integer",
"description":"How many users are present in this response.",
"format":"int32",
"example":2
},
"users":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the user.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"Alice"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Brown"
},
"userName":{
"type":"string",
"description":"User's login name.",
"example":"alicebrown"
},
"emailAddress":{
"type":"string",
"description":"User's email address.",
"example":"alice.brown@email.com"
}
},
"description":"User details including name, username, and email address.",
"example":[
{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"firstName":"Alice",
"lastName":"Brown",
"userName":"alicebrown",
"emailAddress":"alice.brown@email.com"
}
]
}
},
"description":"Paginated result set of users for a global role."
},
"DisplayStudyRoleDtoV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique study role ID (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Single study role assignment in a mode. Includes primary ID, display label, and version validity dates (inherited from DisplayAuthBaseDto).",
"example":[
{
"id":"1A9CF1A460CD440CA62B6F9EA258F968",
"studyRoleName":"Investigator",
"versionStart":"2021-07-01T00:00:00.000Z",
"versionEnd":"2024-01-31T23:59:59.000Z"
}
]
},
"DisplayStudyUserStudyRolesDto":{
"title":"DisplayStudyUserStudyRolesDto v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"firstName":{
"type":"string"
},
"lastName":{
"type":"string"
},
"userName":{
"type":"string"
},
"email":{
"type":"string"
},
"studyRole":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DisplayStudyRoleDtoV2"
}
}
},
"description":"Authorized User Info"
},
"DisplayStudyUserStudyRolesListDto":{
"type":"object",
"properties":{
"usersFound":{
"type":"integer",
"format":"int32"
},
"users":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DisplayStudyUserStudyRolesDto"
}
}
}
},
"UserIdsReq":{
"type":"object",
"properties":{
"userIds":{
"type":"array",
"description":"List of user IDs for which roles or study access is requested.",
"format":"uuid",
"example":[
"11223344AABBCCDD11223344AABBCCDD",
"FFEEDDCCBBAA99887766554433221100"
],
"items":{
"type":"string",
"description":"List of user IDs for which roles or study access is requested.",
"format":"uuid"
}
}
},
"description":"Payload listing userIds for which study roles are to be fetched.",
"example":{
"userIds":[
"11223344AABBCCDD11223344AABBCCDD",
"FFEEDDCCBBAA99887766554433221100"
]
}
},
"StudyRolesIdsReq":{
"required":[
"studyRoleIds"
],
"type":"object",
"properties":{
"siteIds":{
"type":"array",
"description":"Optional list of site IDs to further restrict or filter the results.",
"example":[
"F3183B73D07340CAB883B592E27C8E56",
"ECBDC5486B63400E9F1DE56E470C7U8F"
],
"items":{
"type":"string",
"description":"Optional list of site IDs to further restrict or filter the results.",
"example":"[\"F3183B73D07340CAB883B592E27C8E56\",\"ECBDC5486B63400E9F1DE56E470C7U8F\"]"
}
},
"studyRoleIds":{
"type":"array",
"description":"List of study role IDs for which users are to be fetched.",
"format":"uuid",
"example":[
"F3183B73D07340CAB883B592E27C8E58",
"ECBDC5486B63400E9F1DE56E470C7B8F"
],
"items":{
"type":"string",
"description":"List of study role IDs for which users are to be fetched.",
"format":"uuid"
}
}
},
"description":"Payload listing studyRoleIds and siteIds for which users are to be queried/filtered.",
"example":{
"studyRoleIds":[
"F3183B73D07340CAB883B592E27C8E58",
"ECBDC5486B63400E9F1DE56E470C7B8F"
],
"siteIds":[
"SiteA",
"SiteB"
]
}
},
"DisplayDepotNamesListDto":{
"type":"object",
"properties":{
"allDepots":{
"type":"boolean",
"description":"Flag indicating if the user has access to all depots within the study.",
"example":false
},
"associatedDepots":{
"type":"array",
"description":"List of associated depot names for the user.",
"example":[
"DepotA"
],
"items":{
"type":"string",
"description":"List of associated depot names for the user.",
"example":"[\"DepotA\"]"
}
}
},
"description":"Represents a set of depot access information for the user within a study, including all-depots flag and associated depot names.",
"example":{
"allDepots":false,
"associatedDepots":[
"DepotA"
]
}
},
"DisplaySiteNamesListDto":{
"type":"object",
"properties":{
"allSites":{
"type":"boolean",
"description":"Flag indicating if the user has access to all sites within the study.",
"example":false
},
"associatedSites":{
"type":"array",
"description":"List of associated site names for the user.",
"example":[
"SiteA",
"SiteB"
],
"items":{
"type":"string",
"description":"List of associated site names for the user.",
"example":"[\"SiteA\",\"SiteB\"]"
}
}
},
"description":"Represents a set of site access information for the user within a study, including all-sites flag and associated site names.",
"example":{
"allSites":false,
"associatedSites":[
"SiteA",
"SiteB"
]
}
},
"DisplayStudyUserDtoV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier of the user within the study.",
"format":"uuid"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"John"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Doe"
},
"email":{
"type":"string",
"description":"User's email address.",
"format":"email",
"example":"studyuser@example.com"
},
"phone":{
"type":"string",
"description":"User's phone number.",
"example":"+1-222-333-4444"
},
"userName":{
"type":"string",
"description":"Username used for authentication.",
"example":"jdoe"
},
"lastAccess":{
"type":"string",
"description":"Timestamp (ISO8601/Z) when user last accessed the study.",
"format":"date-time",
"example":"2022-06-20T13:51:51Z"
},
"effectiveStart":{
"type":"string",
"description":"Effective start date for user's study access (ISO8601/Z).",
"format":"date-time",
"example":"2021-01-17T01:00:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"Effective end date for user's study access (ISO8601/Z).",
"format":"date-time",
"example":"2025-01-17T01:00:00Z"
},
"roles":{
"type":"array",
"description":"Roles assigned to the user within the study.",
"example":[
"Rule Designer",
"Site User"
],
"items":{
"type":"string",
"description":"Roles assigned to the user within the study.",
"example":"[\"Rule Designer\",\"Site User\"]"
}
},
"sites":{
"$ref":"#/components/schemas/DisplaySiteNamesListDto"
},
"depots":{
"$ref":"#/components/schemas/DisplayDepotNamesListDto"
}
},
"description":"Version 2: Extends DisplayStudyUserDto to include user email and phone information.",
"example":{
"id":"7DC8B36EA5C04E1F9D11C0E5F3FFF789",
"firstName":"Jane",
"lastName":"Smith",
"userName":"jsmith",
"lastAccess":"2023-12-19T12:42:11.000Z",
"effectiveStart":"2021-06-11T10:00:00.000Z",
"effectiveEnd":"2025-09-21T10:00:00.000Z",
"roles":[
"Site User",
"Rule Designer"
],
"sites":{
"allSites":false,
"associatedSites":[
"7DC8B36EA5C04E1F9D11C0E5F3FFF780",
"6DC8B36EA5C04E1F9D11C0E5F3FFF789"
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
"7DC8B36EA5W04E1F9D11C0E5F3FFF789"
]
},
"email":"studyuser@example.com",
"phone":"+1-222-333-4444"
}
},
"DisplayDepotDtoV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Depot unique identifier (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"depotName":{
"type":"string",
"description":"Name/label for the assigned depot.",
"example":"VaultDepot1"
},
"roleName":{
"type":"string",
"writeOnly":true
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Represents a single depot facility mapped to the user/mode assignment. UUID is always uppercase.",
"example":[
{
"depotId":"7A01356CE45847A0B2B4E5D7DDA18942",
"name":"Vault"
}
]
},
"DisplayDepotsListDtoV2":{
"type":"object",
"properties":{
"allDepots":{
"type":"boolean",
"description":"Global depot mapping: if true, all depots are assigned to this user/mode.",
"example":true
},
"associatedDepots":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Depot unique identifier (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"depotName":{
"type":"string",
"description":"Name/label for the assigned depot.",
"example":"VaultDepot1"
},
"roleName":{
"type":"string",
"writeOnly":true
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Represents a single depot facility mapped to the user/mode assignment. UUID is always uppercase.",
"example":[
{
"depotId":"7A01356CE45847A0B2B4E5D7DDA18942",
"name":"Vault"
}
]
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Collection representing the set of depots mapped for a user/mode. Includes global/all flag and list of detailed depot associations.",
"example":{
"allDepots":true,
"names":[
]
}
},
"DisplaySiteDtoV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Site unique identifier (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"siteName":{
"type":"string",
"description":"Human-readable name for the assigned site.",
"example":"Site123"
},
"roleName":{
"type":"string",
"writeOnly":true
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Represents a single site mapped to user/mode assignments. UUID is always uppercase.",
"example":[
{
"siteId":"2BC6B6F87E774B24A20C769C2B80B7F5",
"name":"SiteA"
}
]
},
"DisplaySitesListDtoV2":{
"type":"object",
"properties":{
"allSites":{
"type":"boolean",
"description":"Global site mapping: if true, all sites are assigned to this user/mode.",
"example":false
},
"associatedSites":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Site unique identifier (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"siteName":{
"type":"string",
"description":"Human-readable name for the assigned site.",
"example":"Site123"
},
"roleName":{
"type":"string",
"writeOnly":true
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Represents a single site mapped to user/mode assignments. UUID is always uppercase.",
"example":[
{
"siteId":"2BC6B6F87E774B24A20C769C2B80B7F5",
"name":"SiteA"
}
]
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Collection representing the set of sites mapped for a user/mode. Includes global/all flag and list of detailed site associations.",
"example":{
"allSites":false,
"siteIds":[
"21F6B67B398A4977A19964FF7B7A68FD"
]
}
},
"DisplayStudyUserDtoV3":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"User's unique ID.",
"format":"uuid"
},
"firstName":{
"type":"string",
"description":"First name of the user.",
"example":"Priya"
},
"lastName":{
"type":"string",
"description":"Last name of the user.",
"example":"Sundaram"
},
"email":{
"type":"string",
"description":"Primary email address for the user.",
"example":"priya.sundaram@examplemail.com"
},
"phone":{
"type":"string",
"description":"Phone or contact information for the user.",
"example":"+1-404-505-6060"
},
"userName":{
"type":"string",
"description":"Login username for the user.",
"example":"psundaram"
},
"lastAccess":{
"type":"string",
"description":"Date and time of user's last access (ISO 8601).",
"format":"date-time",
"example":"2023-08-08T12:00:00Z"
},
"effectiveStart":{
"type":"string",
"description":"Effective start date for the user's study assignment (ISO 8601).",
"format":"date-time",
"example":"2021-06-01T00:00:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"Effective end date for the user's study assignment (ISO 8601).",
"format":"date-time",
"example":"2024-05-31T23:59:59Z"
},
"modes":{
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"Study mode for these assignments (e.g., active, training, etc.)",
"example":"active"
},
"roles":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique role ID",
"example":"F0DEEFCB66A14C2AA0699165055A38C1"
},
"roleName":{
"type":"string",
"description":"Display name for this application or system role.",
"example":"Data Manager"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
},
"studyRoleId":{
"type":"string",
"description":"If present, the mapped studyRoleId for this user/type.",
"example":"23FF2AE2F25746B993190A489ED09727"
}
},
"description":"User role assignment within a study mode. Contains role reference, display label, and (if set) a mapped studyRoleId. UUIDs are always uppercase.",
"example":[
{
"id":"F0DEEFCB66A14C2AA0699165055A38C1",
"roleName":"Data Manager"
}
]
},
"studyRole":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique study role ID (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Single study role assignment in a mode. Includes primary ID, display label, and version validity dates (inherited from DisplayAuthBaseDto).",
"example":[
{
"id":"1A9CF1A460CD440CA62B6F9EA258F968",
"studyRoleName":"Investigator",
"versionStart":"2021-07-01T00:00:00.000Z",
"versionEnd":"2024-01-31T23:59:59.000Z"
}
]
},
"sites":{
"$ref":"#/components/schemas/DisplaySitesListDtoV2"
},
"depots":{
"$ref":"#/components/schemas/DisplayDepotsListDtoV2"
}
},
"description":"All assignment information for a user in a given mode (e.g., active, training) including roles, study roles, mapped sites and mapped depots. This object is a key part of user-level responses.",
"example":[
{
"modeName":"active",
"roles":[
{
"id":"F0DEEFCB66A14C2AA0699165055A38C1",
"roleName":"Data Manager"
}
],
"studyRole":[
{
"id":"1A9CF1A460CD440CA62B6F9EA258F968",
"studyRoleName":"Investigator",
"versionStart":"2021-07-01T00:00:00.000Z",
"versionEnd":"2024-01-31T23:59:59.000Z"
}
],
"sites":{
"allSites":false,
"siteIds":[
"21F6B67B398A4977A19964FF7B7A68FD"
]
},
"depots":{
"allDepots":true,
"names":[
]
}
}
]
}
},
"description":"Full representation of a user returned in the study-users APIs. Covers all identifiers, contact, temporal, and role/mode/assignment details. See the 'modes' property for full expansion of all site/role/depot assignments.",
"example":[
{
"id":"B29BC40C838C42C5972D35880BEBB403",
"firstName":"Alice",
"lastName":"Lee",
"userName":"alice.lee",
"email":"alice.lee@fakemail.org",
"phone":"+1-101-202-3030",
"lastAccess":"2024-02-14T18:00:00.000Z",
"effectiveStart":"2023-01-01T00:00:00.000Z",
"effectiveEnd":"2025-12-31T23:59:59.000Z",
"modes":[
{
"modeName":"active",
"roles":[
{
"id":"AABBCCDDEEFF112233445566778899AA",
"roleName":"Site Coordinator"
}
],
"studyRole":[
{
"id":"D0F1E2C3B4A5968775CCEE8855229966",
"studyRoleName":"Monitor",
"versionStart":"2021-01-01T00:00:00.000Z",
"versionEnd":"2024-12-31T23:59:59.000Z"
}
],
"sites":{
"allSites":false,
"siteIds":[
"817F1E2B3D4C5678A1928833BFA40721"
]
},
"depots":{
"allDepots":false,
"names":[
"DepotZ"
]
}
}
]
}
]
},
"DisplayStudyUserListDtoV3":{
"type":"object",
"properties":{
"usersFound":{
"type":"integer",
"description":"Total count of users matching the filter or query.",
"format":"int32",
"example":2
},
"firstUserReturned":{
"type":"integer",
"description":"Index of the first user returned in this page (1-based).",
"format":"int32",
"example":1
},
"usersReturned":{
"type":"integer",
"description":"Count of user entries included in this result slice.",
"format":"int32",
"example":2
},
"users":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"User's unique ID.",
"format":"uuid"
},
"firstName":{
"type":"string",
"description":"First name of the user.",
"example":"Priya"
},
"lastName":{
"type":"string",
"description":"Last name of the user.",
"example":"Sundaram"
},
"email":{
"type":"string",
"description":"Primary email address for the user.",
"example":"priya.sundaram@examplemail.com"
},
"phone":{
"type":"string",
"description":"Phone or contact information for the user.",
"example":"+1-404-505-6060"
},
"userName":{
"type":"string",
"description":"Login username for the user.",
"example":"psundaram"
},
"lastAccess":{
"type":"string",
"description":"Date and time of user's last access (ISO 8601).",
"format":"date-time",
"example":"2023-08-08T12:00:00Z"
},
"effectiveStart":{
"type":"string",
"description":"Effective start date for the user's study assignment (ISO 8601).",
"format":"date-time",
"example":"2021-06-01T00:00:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"Effective end date for the user's study assignment (ISO 8601).",
"format":"date-time",
"example":"2024-05-31T23:59:59Z"
},
"modes":{
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"Study mode for these assignments (e.g., active, training, etc.)",
"example":"active"
},
"roles":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique role ID",
"example":"F0DEEFCB66A14C2AA0699165055A38C1"
},
"roleName":{
"type":"string",
"description":"Display name for this application or system role.",
"example":"Data Manager"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
},
"studyRoleId":{
"type":"string",
"description":"If present, the mapped studyRoleId for this user/type.",
"example":"23FF2AE2F25746B993190A489ED09727"
}
},
"description":"User role assignment within a study mode. Contains role reference, display label, and (if set) a mapped studyRoleId. UUIDs are always uppercase.",
"example":[
{
"id":"F0DEEFCB66A14C2AA0699165055A38C1",
"roleName":"Data Manager"
}
]
},
"studyRole":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique study role ID (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Single study role assignment in a mode. Includes primary ID, display label, and version validity dates (inherited from DisplayAuthBaseDto).",
"example":[
{
"id":"1A9CF1A460CD440CA62B6F9EA258F968",
"studyRoleName":"Investigator",
"versionStart":"2021-07-01T00:00:00.000Z",
"versionEnd":"2024-01-31T23:59:59.000Z"
}
]
},
"sites":{
"$ref":"#/components/schemas/DisplaySitesListDtoV2"
},
"depots":{
"$ref":"#/components/schemas/DisplayDepotsListDtoV2"
}
},
"description":"All assignment information for a user in a given mode (e.g., active, training) including roles, study roles, mapped sites and mapped depots. This object is a key part of user-level responses.",
"example":[
{
"modeName":"active",
"roles":[
{
"id":"F0DEEFCB66A14C2AA0699165055A38C1",
"roleName":"Data Manager"
}
],
"studyRole":[
{
"id":"1A9CF1A460CD440CA62B6F9EA258F968",
"studyRoleName":"Investigator",
"versionStart":"2021-07-01T00:00:00.000Z",
"versionEnd":"2024-01-31T23:59:59.000Z"
}
],
"sites":{
"allSites":false,
"siteIds":[
"21F6B67B398A4977A19964FF7B7A68FD"
]
},
"depots":{
"allDepots":true,
"names":[
]
}
}
]
}
},
"description":"Full representation of a user returned in the study-users APIs. Covers all identifiers, contact, temporal, and role/mode/assignment details. See the 'modes' property for full expansion of all site/role/depot assignments.",
"example":[
{
"id":"B29BC40C838C42C5972D35880BEBB403",
"firstName":"Alice",
"lastName":"Lee",
"userName":"alice.lee",
"email":"alice.lee@fakemail.org",
"phone":"+1-101-202-3030",
"lastAccess":"2024-02-14T18:00:00.000Z",
"effectiveStart":"2023-01-01T00:00:00.000Z",
"effectiveEnd":"2025-12-31T23:59:59.000Z",
"modes":[
{
"modeName":"active",
"roles":[
{
"id":"AABBCCDDEEFF112233445566778899AA",
"roleName":"Site Coordinator"
}
],
"studyRole":[
{
"id":"D0F1E2C3B4A5968775CCEE8855229966",
"studyRoleName":"Monitor",
"versionStart":"2021-01-01T00:00:00.000Z",
"versionEnd":"2024-12-31T23:59:59.000Z"
}
],
"sites":{
"allSites":false,
"siteIds":[
"817F1E2B3D4C5678A1928833BFA40721"
]
},
"depots":{
"allDepots":false,
"names":[
"DepotZ"
]
}
}
]
}
]
}
},
"description":"Paginated and detailed response object representing a list of study users, including overall count and returned slice, for API v4 and similar endpoints. Each user entry is deeply expanded, including all modes, role assignments, sites, and depots, as required by downstream consumers."
},
"DisplayUserModeRoleListDtoV3":{
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"Study mode for these assignments (e.g., active, training, etc.)",
"example":"active"
},
"roles":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique role ID",
"example":"F0DEEFCB66A14C2AA0699165055A38C1"
},
"roleName":{
"type":"string",
"description":"Display name for this application or system role.",
"example":"Data Manager"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
},
"studyRoleId":{
"type":"string",
"description":"If present, the mapped studyRoleId for this user/type.",
"example":"23FF2AE2F25746B993190A489ED09727"
}
},
"description":"User role assignment within a study mode. Contains role reference, display label, and (if set) a mapped studyRoleId. UUIDs are always uppercase.",
"example":[
{
"id":"F0DEEFCB66A14C2AA0699165055A38C1",
"roleName":"Data Manager"
}
]
},
"studyRole":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique study role ID (32-character uppercase hexadecimal UUID).",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
},
"description":"Single study role assignment in a mode. Includes primary ID, display label, and version validity dates (inherited from DisplayAuthBaseDto).",
"example":[
{
"id":"1A9CF1A460CD440CA62B6F9EA258F968",
"studyRoleName":"Investigator",
"versionStart":"2021-07-01T00:00:00.000Z",
"versionEnd":"2024-01-31T23:59:59.000Z"
}
]
},
"sites":{
"$ref":"#/components/schemas/DisplaySitesListDtoV2"
},
"depots":{
"$ref":"#/components/schemas/DisplayDepotsListDtoV2"
}
},
"description":"All assignment information for a user in a given mode (e.g., active, training) including roles, study roles, mapped sites and mapped depots. This object is a key part of user-level responses.",
"example":[
{
"modeName":"active",
"roles":[
{
"id":"F0DEEFCB66A14C2AA0699165055A38C1",
"roleName":"Data Manager"
}
],
"studyRole":[
{
"id":"1A9CF1A460CD440CA62B6F9EA258F968",
"studyRoleName":"Investigator",
"versionStart":"2021-07-01T00:00:00.000Z",
"versionEnd":"2024-01-31T23:59:59.000Z"
}
],
"sites":{
"allSites":false,
"siteIds":[
"21F6B67B398A4977A19964FF7B7A68FD"
]
},
"depots":{
"allDepots":true,
"names":[
]
}
}
]
},
"DisplayUserRoleDtoV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique role ID",
"example":"F0DEEFCB66A14C2AA0699165055A38C1"
},
"roleName":{
"type":"string",
"description":"Display name for this application or system role.",
"example":"Data Manager"
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
},
"studyRoleId":{
"type":"string",
"description":"If present, the mapped studyRoleId for this user/type.",
"example":"23FF2AE2F25746B993190A489ED09727"
}
},
"description":"User role assignment within a study mode. Contains role reference, display label, and (if set) a mapped studyRoleId. UUIDs are always uppercase.",
"example":[
{
"id":"F0DEEFCB66A14C2AA0699165055A38C1",
"roleName":"Data Manager"
}
]
},
"RqstUsersSearchSpecificationsDto":{
"type":"object",
"properties":{
"mode":{
"type":"string",
"description":"Study mode for the search",
"example":"active"
},
"sites":{
"$ref":"#/components/schemas/sites"
},
"depots":{
"$ref":"#/components/schemas/depots"
},
"userStatus":{
"type":"string",
"description":"User status for filtering",
"example":"Inactive"
},
"studyRoles":{
"type":"array",
"description":"List of study role UUIDs",
"example":[
"AF73A2EEA90B4E9394CE6CB40B5BC66E"
],
"items":{
"type":"string",
"description":"List of study role UUIDs",
"format":"uuid"
}
},
"studyRoleTypes":{
"type":"array",
"description":"List of study role types",
"example":[
"PrincipalInvestigator"
],
"items":{
"type":"string",
"description":"List of study role types",
"example":"[\"PrincipalInvestigator\"]"
}
},
"searchString":{
"type":"string",
"description":"Free text to search/filter users",
"example":"site, US"
},
"sortBy":{
"type":"string",
"description":"Result sort column",
"example":"lastName"
},
"sortOrder":{
"type":"string",
"description":"Sort order, ascending/descending",
"example":"asc"
}
}
},
"depots":{
"type":"object",
"properties":{
"allDepots":{
"type":"boolean"
},
"depotIds":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
}
},
"description":"Depots data to filter the users",
"example":{
"names":[
"DepotA"
]
}
},
"sites":{
"type":"object",
"properties":{
"allSites":{
"type":"boolean"
},
"siteIds":{
"type":"array",
"items":{
"type":"string",
"format":"uuid"
}
}
},
"description":"Sites data to filter the users",
"example":{
"ids":[
"123F0B1426C11EE90C31234567890AAA"
]
}
},
"RoleIdDto":{
"required":[
"roleId"
],
"type":"object",
"properties":{
"roleId":{
"type":"string",
"description":"Unique identifier for the role.",
"format":"uuid"
}
},
"description":"Simple DTO containing only the role's unique identifier.",
"example":{
"roleId":"078123AF1E024F7C8D0053D74A11AEC3"
}
},
"StudyRolePostDto":{
"required":[
"roleList",
"studyRoleName",
"studyRoleType"
],
"type":"object",
"properties":{
"studyRoleName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the study role.",
"example":"SITE_COORDINATOR"
},
"studyRoleDesc":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Description of the study role.",
"example":"Can manage subject and site data."
},
"studyRoleType":{
"type":"string",
"description":"Type of the study role.",
"example":"SITE"
},
"studyRoleStatus":{
"type":"string",
"description":"Status of the study role.",
"example":"ACTIVE"
},
"studyRoleCreationType":{
"type":"string",
"description":"Indicates how the study role was created.",
"example":"MANUAL"
},
"roleList":{
"$ref":"#/components/schemas/RoleIdDto"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for creating or updating this study role.",
"example":"Configured at initial setup."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments about the study role.",
"example":"Primary coordinator assignment for site."
}
},
"description":"DTO to create a new study role with requested settings and related roles.",
"example":{
"studyRoleName":"SITE_COORDINATOR",
"studyRoleDesc":"Can manage subject and site data.",
"studyRoleType":"SITE",
"studyRoleStatus":"ACTIVE",
"studyRoleCreationType":"MANUAL",
"roleList":[
{
"roleId":"C2F3B799BCED4C868E668A002A3F30F3"
}
],
"reason":"Configured at initial setup.",
"comment":"Primary coordinator assignment for site."
}
},
"RoleObjectNumDto":{
"required":[
"objectVersionNumber",
"roleId"
],
"type":"object",
"properties":{
"roleId":{
"type":"string",
"description":"Unique identifier for the role.",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number",
"description":"Current object version number for the role.",
"example":1
}
},
"description":"Represents a role reference along with its object version number.",
"example":{
"roleId":"ED123C41A2304E21850F4A2B92FED971",
"objectVersionNumber":1
}
},
"StudyRoleDto":{
"required":[
"roleList",
"studyRoleId",
"studyRoleName",
"studyRoleType"
],
"type":"object",
"properties":{
"studyRoleId":{
"type":"string",
"description":"Unique identifier for this study role.",
"format":"uuid"
},
"studyRoleName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the study role.",
"example":"SITE_VIEWER"
},
"studyRoleDesc":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Description of the study role.",
"example":"A role allowing access to all site-specific data."
},
"studyRoleType":{
"type":"string",
"description":"Type of the study role.",
"example":"SITE"
},
"studyRoleCreationType":{
"type":"string",
"description":"How the study role was created (e.g., MANUAL, AUTO).",
"example":"MANUAL"
},
"roleList":{
"$ref":"#/components/schemas/RoleObjectNumDto"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for assigning or modifying this study role.",
"example":"Initial assignment."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments about the study role.",
"example":"This group was created as part of baseline configuration."
}
},
"description":"Describes a study role with its associated details and constituent roles.",
"example":{
"studyRoleId":"6D84A3F9D41E4BB8B5FC99A27DCC2B9B",
"studyRoleName":"SITE_VIEWER",
"studyRoleDesc":"A role allowing access to all site-specific data.",
"studyRoleType":"SITE",
"studyRoleCreationType":"MANUAL",
"roleList":[
{
"roleId":"ED123C41A2304E21850F4A2B92FED971",
"objectVersionNumber":1
}
],
"reason":"Initial assignment.",
"comment":"This group was created as part of baseline configuration."
}
},
"DisplayRightDtoV2":{
"required":[
"id",
"rightName"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"The unique identifier for the right.",
"format":"uuid"
},
"rightName":{
"type":"string",
"description":"The name of the right.",
"example":"ACCESS_SUBJECT_DATA"
}
},
"description":"A right associated with a role. Contains the unique identifier and name of the right.",
"example":{
"id":"A8C7B83378261E99F4A6823F43A6063B",
"rightName":"ACCESS_SUBJECT_DATA"
}
},
"DisplayRoleWithRightsDto":{
"required":[
"id",
"roleCategory",
"roleName"
],
"type":"object",
"properties":{
"objectVersionNumber":{
"type":"number",
"description":"Object version number.",
"example":3
},
"selected":{
"type":"boolean",
"description":"Indicates if this role is selected.",
"example":true
},
"rights":{
"required":[
"id",
"rightName"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"The unique identifier for the right.",
"format":"uuid"
},
"rightName":{
"type":"string",
"description":"The name of the right.",
"example":"ACCESS_SUBJECT_DATA"
}
},
"description":"A right associated with a role. Contains the unique identifier and name of the right.",
"example":{
"id":"A8C7B83378261E99F4A6823F43A6063B",
"rightName":"ACCESS_SUBJECT_DATA"
}
},
"id":{
"type":"string",
"description":"The unique identifier for the role.",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Name of the role.",
"example":"Rule Designer"
},
"roleCategory":{
"type":"string",
"description":"Category to which the role belongs.",
"example":"STUDY_SPECIFIC"
},
"roleSubCategory":{
"type":"string",
"description":"Sub-category for this role.",
"example":"LEAD"
},
"unblinded":{
"type":"string",
"description":"Whether the role is unblinded ('YES' or 'NO').",
"example":"YES"
}
},
"description":"Represents a role with associated rights and additional attributes.",
"example":{
"id":"D2FEB81D0E364B22B2EE172CD220A1D1",
"roleName":"Rule Designer",
"roleCategory":"STUDY_SPECIFIC",
"roleSubCategory":"LEAD",
"unblinded":"YES",
"objectVersionNumber":3,
"selected":true,
"rights":[
{
"id":"A8C7B83378261E99F4A6823F43A6063B",
"rightName":"ACCESS_SUBJECT_DATA"
}
]
}
},
"DisplayStudyRightPropertiesDto":{
"required":[
"displayName",
"rightName"
],
"type":"object",
"properties":{
"displayName":{
"type":"string",
"description":"Human-readable name for this right.",
"example":"Create shipments to DDF"
},
"rightName":{
"type":"string",
"description":"Right name identifier.",
"example":"OrsSiteShipmentPost"
}
},
"description":"DTO for right display information including human-readable name and identifier.",
"example":[
{
"displayName":"Create shipments to DDF",
"rightName":"OrsSiteShipmentPost"
}
]
},
"DisplayStudyRoleRightsDto":{
"required":[
"activeStatus",
"rights",
"roleCategory",
"roleId",
"roleName",
"roleType"
],
"type":"object",
"properties":{
"roleId":{
"type":"string",
"description":"Unique identifier for the study role.",
"example":"B748C913E61B4B18A9B5D80F349BC8FD"
},
"roleName":{
"type":"string",
"description":"Name of the study role.",
"example":"Site User"
},
"roleCategory":{
"type":"string",
"description":"Category of the study role (e.g., SITE_SPECIFIC, STUDY_SPECIFIC).",
"example":"Site"
},
"activeStatus":{
"type":"string",
"description":"Active status of the study role.",
"example":"Active"
},
"roleType":{
"type":"string",
"description":"Type of the role",
"example":"Runtime"
},
"rights":{
"required":[
"displayName",
"rightName"
],
"type":"object",
"properties":{
"displayName":{
"type":"string",
"description":"Human-readable name for this right.",
"example":"Create shipments to DDF"
},
"rightName":{
"type":"string",
"description":"Right name identifier.",
"example":"OrsSiteShipmentPost"
}
},
"description":"DTO for right display information including human-readable name and identifier.",
"example":[
{
"displayName":"Create shipments to DDF",
"rightName":"OrsSiteShipmentPost"
}
]
}
},
"description":"Represents a study role with rights details for display."
},
"StudyRoleDtoParams":{
"title":"StudyRoleDtoParams",
"required":[
"studyRoleCreationType",
"studyRoleDesc",
"studyRoleId",
"studyRoleName",
"studyRoleStatus",
"studyRoleType"
],
"type":"object",
"properties":{
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
},
"studyRoleId":{
"type":"string",
"description":"Unique identifier for the study role.",
"format":"uuid"
},
"studyRoleName":{
"type":"string",
"description":"Name of the study role.",
"example":"MONITOR"
},
"studyRoleDesc":{
"type":"string",
"description":"Description of the study role.",
"example":"Monitor role grants viewing and edit capabilities."
},
"studyRoleType":{
"type":"string",
"description":"Type of the study role (e.g., SITE, STUDY).",
"example":"SITE"
},
"studyRoleStatus":{
"type":"string",
"description":"Current status of the study role (e.g., ACTIVE, INACTIVE).",
"example":"ACTIVE"
},
"studyRoleCreationType":{
"type":"string",
"description":"Method used to create the study role (e.g., MANUAL, AUTO).",
"example":"AUTO"
},
"studyId":{
"type":"string",
"description":"Study identifier, if applicable.",
"format":"uuid"
},
"roleId":{
"type":"string",
"description":"Role identifier, if relevant.",
"format":"uuid"
}
},
"description":"Parameters for a study role, including inherited version validity."
},
"RqstCreateBulkUsersDto":{
"type":"object",
"properties":{
"isFederatedUser":{
"type":"boolean",
"description":"True if the users are federated users.",
"example":true
},
"isTrainingModeUpload":{
"type":"boolean",
"description":"True if the users are part of a training mode upload.",
"example":false
},
"comment":{
"type":"string",
"description":"Optional comment for the bulk user creation.",
"example":"Bulk upload of new investigators"
},
"users":{
"$ref":"#/components/schemas/UploadUserDetails"
}
}
},
"UploadUserDetails":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the user.",
"format":"uuid"
},
"idcsId":{
"type":"string",
"description":"IDCS identifier if federated.",
"format":"uuid"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"John"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Smith"
},
"userName":{
"type":"string",
"description":"User's login name.",
"example":"jsmith"
},
"emailId":{
"type":"string",
"description":"User's email address.",
"example":"john.smith@email.com"
},
"role":{
"type":"string",
"description":"Assigned user role.",
"example":"SiteAdmin"
},
"sites":{
"type":"string",
"description":"Comma separated list of associated site names.",
"example":"SiteA,SiteB"
},
"depots":{
"type":"string",
"description":"Comma separated list of associated depots.",
"example":"DepotA"
},
"startDate":{
"type":"string",
"description":"Start date of user assignment in ISO format.",
"format":"date"
},
"endDate":{
"type":"string",
"description":"End date of user assignment in ISO format.",
"format":"date"
}
},
"description":"Details required for a single user in a bulk upload.",
"example":{
"id":"F6B4E947CA41478DBE30CEF0A823BC43",
"idcsId":"D196BD697CB34E169A7D8E465AB8B2F5",
"firstName":"John",
"lastName":"Smith",
"userName":"jsmith",
"emailId":"john.smith@email.com",
"role":"SiteAdmin",
"sites":"SiteA,SiteB",
"depots":"DepotA",
"startDate":"2025-12-31T00:00:00.000Z",
"endDate":"3099-12-31T00:00:00.000Z"
}
},
"BulkUsersUploadDetailsDto":{
"type":"object",
"properties":{
"isFederatedUser":{
"type":"boolean",
"description":"True if the users are federated users.",
"example":true
},
"isTrainingModeUpload":{
"type":"boolean",
"description":"True if the users are part of a training mode upload.",
"example":false
},
"comment":{
"type":"string",
"description":"Optional comment for the bulk user creation.",
"example":"Bulk upload of new investigators"
},
"users":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the user.",
"format":"uuid"
},
"idcsId":{
"type":"string",
"description":"IDCS identifier if federated.",
"format":"uuid"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"John"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Smith"
},
"userName":{
"type":"string",
"description":"User's login name.",
"example":"jsmith"
},
"emailId":{
"type":"string",
"description":"User's email address.",
"example":"john.smith@email.com"
},
"role":{
"type":"string",
"description":"Assigned user role.",
"example":"SiteAdmin"
},
"sites":{
"type":"string",
"description":"Comma separated list of associated site names.",
"example":"SiteA,SiteB"
},
"depots":{
"type":"string",
"description":"Comma separated list of associated depots.",
"example":"DepotA"
},
"startDate":{
"type":"string",
"description":"Start date of user assignment in ISO format.",
"format":"date"
},
"endDate":{
"type":"string",
"description":"End date of user assignment in ISO format.",
"format":"date"
}
},
"description":"Details required for a single user in a bulk upload.",
"example":{
"id":"F6B4E947CA41478DBE30CEF0A823BC43",
"idcsId":"D196BD697CB34E169A7D8E465AB8B2F5",
"firstName":"John",
"lastName":"Smith",
"userName":"jsmith",
"emailId":"john.smith@email.com",
"role":"SiteAdmin",
"sites":"SiteA,SiteB",
"depots":"DepotA",
"startDate":"2025-12-31T00:00:00.000Z",
"endDate":"3099-12-31T00:00:00.000Z"
}
}
},
"description":"Payload for uploading a batch of users, including user details and bulk flags."
},
"DisplayUserDto2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the user.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"Alice"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Brown"
},
"userName":{
"type":"string",
"description":"User's login name.",
"example":"alicebrown"
},
"emailAddress":{
"type":"string",
"description":"User's email address.",
"example":"alice.brown@email.com"
},
"versionStart":{
"type":"string",
"description":"Timestamp for when this version of the user record started.",
"format":"date-time",
"example":"2023-01-01T10:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"Timestamp for when this version of the user record ended.",
"format":"date-time",
"example":"2024-01-01T10:00:00Z"
},
"operationType":{
"type":"string",
"description":"Type of operation performed (e.g., CREATE, UPDATE, DELETE).",
"example":"CREATE"
},
"objectVersionNumber":{
"type":"number",
"description":"Version number for the user object.",
"format":"double",
"example":2
},
"softwareVersionNumber":{
"type":"number",
"description":"Version number for the software.",
"format":"double",
"example":1.5
}
},
"description":"User details extending DisplayUserDto with versioning and auditing fields."
},
"RqstUpdateBulkUsersEffectiveDatesDto":{
"type":"object",
"properties":{
"userIds":{
"type":"array",
"description":"List of user UUIDs to update.",
"example":[
"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"21E0C8A2C11045A584ADEA8760F72E58"
],
"items":{
"type":"string",
"description":"List of user UUIDs to update.",
"format":"uuid"
}
},
"allUsers":{
"type":"boolean",
"description":"Whether to update all users matching userSearchSpecs.",
"example":false
},
"userSearchSpecs":{
"$ref":"#/components/schemas/UsersSearchSpecificationsDto"
},
"effectiveStart":{
"type":"string",
"description":"Effective start date/time for the selected user assignments.",
"format":"date-time",
"example":"2024-01-01T08:00:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"Effective end date/time for the selected user assignments.",
"format":"date-time",
"example":"2025-12-31T17:30:00Z"
}
}
},
"UsersSearchSpecificationsDto":{
"type":"object",
"properties":{
"mode":{
"type":"string",
"description":"Study mode for the search",
"example":"active"
},
"sites":{
"$ref":"#/components/schemas/sites"
},
"depots":{
"$ref":"#/components/schemas/depots"
},
"userStatus":{
"type":"string",
"description":"User status for filtering",
"example":"Inactive"
},
"studyRoles":{
"type":"array",
"description":"List of study role UUIDs",
"example":[
"AF73A2EEA90B4E9394CE6CB40B5BC66E"
],
"items":{
"type":"string",
"description":"List of study role UUIDs",
"format":"uuid"
}
},
"studyRoleTypes":{
"type":"array",
"description":"List of study role types",
"example":[
"PrincipalInvestigator"
],
"items":{
"type":"string",
"description":"List of study role types",
"example":"[\"PrincipalInvestigator\"]"
}
},
"searchString":{
"type":"string",
"description":"Free text to search/filter users",
"example":"site, US"
},
"sortBy":{
"type":"string",
"description":"Result sort column",
"example":"lastName"
},
"sortOrder":{
"type":"string",
"description":"Sort order, ascending/descending",
"example":"asc"
}
},
"description":"Search/filter specifications for selecting users during bulk role/effective/site updates."
},
"BulkUsersEffectiveDatesUpdateDetailsDto":{
"type":"object",
"properties":{
"userIds":{
"type":"array",
"description":"List of user IDs to update (if bulk selection not by query)",
"example":[
"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"2ABC8A2C11045A584ADEA8760F72B114"
],
"items":{
"type":"string",
"description":"List of user IDs to update (if bulk selection not by query)",
"format":"uuid"
}
},
"allUsers":{
"type":"boolean",
"description":"Flag indicating if operation should apply to all users found by userSearchSpecs. If true, all users matching the search will be updated; otherwise, only those explicitly listed in userIds.",
"example":false
},
"userSearchSpecs":{
"$ref":"#/components/schemas/UsersSearchSpecificationsDto"
},
"effectiveStart":{
"type":"string",
"description":"Effective start date/time to set (in ISO 8601 format).",
"format":"date-time",
"example":"2023-01-01T00:00:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"Effective end date/time to set (in ISO 8601 format).",
"format":"date-time",
"example":"2024-12-31T23:59:59Z"
}
},
"description":"Request payload for performing bulk update of effective start/end dates for a set of users in a study. Selection of users may be done by explicit userId, allUsers, or the userSearchSpecs criteria. All date-times use ISO 8601 string format."
},
"RqstUpdateBulkUsersRoleDto":{
"type":"object",
"properties":{
"mode":{
"type":"string",
"description":"The role assignment mode (e.g. active, expired)",
"example":"active"
},
"studyRoleId":{
"type":"string",
"description":"The study role UUID to assign.",
"format":"uuid"
},
"userIds":{
"type":"array",
"description":"List of user UUIDs to update.",
"example":[
"21E0C8A2C11045A584ADEA8760F72E58",
"F6B4E947CA41478DBE30CEF0A823BC43"
],
"items":{
"type":"string",
"description":"List of user UUIDs to update.",
"format":"uuid"
}
},
"allUsers":{
"type":"boolean",
"description":"Whether to apply the update to all users.",
"example":false
},
"userSearchSpecs":{
"$ref":"#/components/schemas/UsersSearchSpecificationsDto"
}
}
},
"BulkUsersRoleUpdateDetailsDto":{
"type":"object",
"properties":{
"mode":{
"type":"string",
"description":"The study mode for role update (e.g., active, design, training, etc).",
"example":"active"
},
"studyRoleId":{
"type":"string",
"description":"Study role ID to assign",
"example":"F3183B73D07340CAB883B592E27C8E58"
},
"userIds":{
"type":"array",
"description":"List of user IDs to update.",
"format":"uuid",
"example":[
"A9C3EDCB5A7E4CA3AF9E1A981187B2CB",
"E439B8E7C1D24B2C9EFAE3C9378F009A"
],
"items":{
"type":"string",
"description":"List of user IDs to update.",
"format":"uuid"
}
},
"allUsers":{
"type":"boolean",
"description":"Flag indicating if operation should apply to all users matching userSearchSpecs. If true, all users resulting from the filter will be updated; otherwise, only those explicitly listed in userIds.",
"example":false
},
"userSearchSpecs":{
"$ref":"#/components/schemas/UsersSearchSpecificationsDto"
}
},
"description":"Request payload for performing bulk role assignments or updates for a set of users in a study. Selection of users may be done by explicit userId, allUsers, or the userSearchSpecs criteria."
},
"RqstUpdateBulkUsersSitesDto":{
"required":[
"modeName"
],
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"Mode name for the site update.",
"example":"active"
},
"userIds":{
"type":"array",
"description":"List of user UUIDs to update.",
"example":[
"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"21E0C8A2C11045A584ADEA8760F72E58"
],
"items":{
"type":"string",
"description":"List of user UUIDs to update.",
"format":"uuid"
}
},
"allUsers":{
"type":"boolean",
"description":"Whether to apply to all users matching userSearchSpecs.",
"example":false
},
"userSearchSpecs":{
"$ref":"#/components/schemas/UsersSearchSpecificationsDto"
},
"allSites":{
"type":"boolean",
"description":"Whether to update all sites for the selected users.",
"example":false
},
"associatedSites":{
"type":"array",
"description":"List of associated site UUIDs.",
"example":[
"666666D084BB4680AC08AEF5DC8B0EE9",
"88888814875B45D5B700987A23A823E2"
],
"items":{
"type":"string",
"description":"List of associated site UUIDs.",
"format":"uuid"
}
}
}
},
"BulkUsersSitesUpdateDetailsDto":{
"required":[
"modeName"
],
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"Name of the study mode (e.g., active, design, etc) for which site association is applied.",
"example":"active"
},
"userIds":{
"type":"array",
"description":"List of user IDs to update sites for.",
"example":[
"54B6FD8C920E4D19A259C4A9C7033A85",
"BC2A5EEDA88F4791A4B5B7F83D1F8317"
],
"items":{
"type":"string",
"description":"List of user IDs to update sites for.",
"format":"uuid"
}
},
"allUsers":{
"type":"boolean",
"description":"Flag stating if all users found by userSearchSpecs should be included. If true, applies to all; if false, applies to userIds only.",
"example":false
},
"userSearchSpecs":{
"$ref":"#/components/schemas/UsersSearchSpecificationsDto"
},
"allSites":{
"type":"boolean",
"description":"If true, associate all current/future sites with users; if false, uses provided associatedSites.",
"example":false
},
"associatedSites":{
"type":"array",
"description":"List of site UUIDs to be associated with users.",
"format":"uuid",
"example":[
"764620086A994885B67EDD158E3EA3D1",
"3F786850E387550FDAB836ED7E6DC881"
],
"items":{
"type":"string",
"description":"List of site UUIDs to be associated with users.",
"format":"uuid"
}
}
},
"description":"Request payload for performing bulk site associations or updates for a set of users in a study. Selection may be made by explicit userIds, allUsers, or via the userSearchSpecs filter. Site associations can be provided explicitly (associatedSites) or set globally via allSites."
},
"DisplayGlobalRoleDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the global role.",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"The name of the role.",
"example":"Approve Library Objects"
},
"rights":{
"type":"array",
"description":"List of rights related to the global role.",
"example":[
"READ",
"WRITE"
],
"items":{
"type":"string",
"description":"List of rights related to the global role.",
"example":"[\"READ\",\"WRITE\"]"
}
}
},
"description":"Represents a global role with its ID, name, and related rights.",
"example":{
"id":"07968CA58DAF356CAF7BCD708ADCB159",
"roleName":"Approve Library Objects",
"rights":[
"READ",
"WRITE"
]
}
},
"DisplayUserRoleDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for this user-role association.",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Name of the role assigned to the user.",
"example":"STUDY_MANAGER"
}
},
"description":"Associates a user with a global role.",
"example":{
"id":"A519EF3C2B73455390CFF812AFF61519",
"roleName":"STUDY_MANAGER"
}
},
"UserInfoDtoV2":{
"type":"object",
"properties":{
"firstName":{
"type":"string",
"description":"First name of the user.",
"example":"Jane"
},
"lastName":{
"type":"string",
"description":"Last name of the user.",
"example":"Doe"
},
"emailAddress":{
"type":"string",
"description":"Email address of the user.",
"format":"email",
"example":"jane.doe@example.com"
},
"globalRights":{
"uniqueItems":true,
"type":"array",
"description":"Global rights assigned to the user.",
"example":[
"OrsSiteShipmentPost",
"UpdateRecipe"
],
"items":{
"type":"string",
"description":"Global rights assigned to the user.",
"example":"[\"OrsSiteShipmentPost\",\"UpdateRecipe\"]"
}
},
"userId":{
"type":"string",
"description":"User identifier.",
"example":"A1234567890B1234567890C12345678E"
},
"userAttributes":{
"type":"object",
"properties":{
"key":{
"type":"string",
"description":"The attribute key name",
"example":"Locale"
},
"value":{
"type":"string",
"description":"The value of the attribute",
"example":"en-US"
}
},
"description":"Key-value pair for user attribute",
"example":{
"key":"Locale",
"value":"en-US"
}
}
},
"description":"User information with rights and attributes"
},
"DisplayUserDtoV3":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the user.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"Alice"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Brown"
},
"userName":{
"type":"string",
"description":"User's login name.",
"example":"alicebrown"
},
"emailAddress":{
"type":"string",
"description":"User's email address.",
"example":"alice.brown@email.com"
},
"workPhone":{
"type":"string",
"description":"Work phone number for the user.",
"example":"+1-808-555-1357"
},
"externalId":{
"type":"string",
"description":"External identifier for the user (from source system).",
"example":"EXT123456"
},
"isSystemUser":{
"type":"boolean",
"description":"Indicates if this is a system user.",
"example":true
},
"versionStart":{
"type":"string",
"description":"Timestamp for when this version of the user record started.",
"format":"date-time",
"example":"2023-01-01T10:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"Timestamp for when this version of the user record ended.",
"format":"date-time",
"example":"2024-01-01T10:00:00Z"
},
"operationType":{
"type":"string",
"description":"Type of operation performed (e.g., CREATE, UPDATE, DELETE).",
"example":"CREATE"
},
"userId":{
"type":"string",
"description":"Alternate user UUID for versioning and reference.",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number",
"description":"Version number for the user object.",
"format":"double",
"example":2
},
"softwareVersionNumber":{
"type":"number",
"description":"Version number for the software.",
"format":"double",
"example":1.5
},
"reason":{
"type":"string",
"description":"Reason for last update/change to user.",
"example":"User promoted to admin"
},
"comment":{
"type":"string",
"description":"Free comment regarding the user or change.",
"example":"Initial bulk upload"
}
},
"description":"Authorized User Info with extended attributes, audit and versioning. Extends DisplayUserDto2."
},
"RoleDtoParamsV3":{
"required":[
"id",
"roleCategory",
"roleName",
"roleType"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"id":{
"type":"string",
"description":"Unique identifier of the application role.",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Human-readable role name.",
"example":"VIEWER"
},
"roleType":{
"type":"string",
"description":"Type of the role (e.g., Application, Study, Global).",
"example":"Application"
},
"roleCategory":{
"type":"string",
"description":"Business category of the role.",
"example":"Study"
},
"roleSubCategory":{
"type":"string"
},
"unblinded":{
"type":"string",
"description":"Indicates if the role is unblinded (Y/N).",
"example":"Y"
},
"roleSeq":{
"type":"number",
"description":"Role sequence/order in assignment.",
"format":"int32",
"example":1
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents an application role and its assignment attributes, including identifiers and display information.",
"example":{
"id":"37EFDC494C944E58ADAC8DA952A2C60C",
"roleName":"Site User",
"roleType":"Application",
"roleCategory":"Study",
"roleSeq":1,
"unblinded":"Y"
}
},
"DisplayRoleDtoV2":{
"required":[
"id",
"objectVersionNumber",
"roleCategory",
"roleName",
"roleType"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the user role",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"roleName":{
"type":"string",
"description":"The display name of the role",
"example":"Monitor"
},
"roleType":{
"type":"string",
"description":"Type of the role (e.g., Runtime, Design)",
"example":"Runtime"
},
"roleCategory":{
"type":"string",
"description":"Category of the role",
"example":"Sponsor"
},
"roleSubCategory":{
"type":"string",
"description":"Sub category of the role if available",
"example":"Central"
},
"unblinded":{
"type":"string",
"description":"Indicates if the role is unblinded (true/false)",
"example":"true"
},
"objectVersionNumber":{
"type":"integer",
"description":"Version number for optimistic locking",
"format":"int32",
"example":1
}
},
"description":"Represents a user role in v2 with additional details."
},
"StudyRoleDtoParamsV2":{
"required":[
"studyRoleCreationType",
"studyRoleId",
"studyRoleName",
"studyRoleStatus",
"studyRoleType"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for this entity.",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"description":"UUID for the study role.",
"format":"uuid"
},
"studyRoleName":{
"type":"string",
"description":"Name of the study role.",
"example":"MONITOR"
},
"studyRoleDesc":{
"type":"string",
"description":"Optional description for this study role.",
"example":"Monitor role grants viewing and edit capabilities."
},
"studyRoleType":{
"type":"string",
"description":"Type (e.g., SITE, STUDY) for this study role.",
"example":"SITE"
},
"studyRoleStatus":{
"type":"string",
"description":"Status string for this role (ACTIVE, INACTIVE, etc).",
"example":"ACTIVE"
},
"studyRoleCreationType":{
"type":"string",
"description":"Role creation method (e.g., MANUAL, AUTO).",
"example":"AUTO"
},
"studyId":{
"type":"string",
"description":"UUID of the study this relates to.",
"format":"uuid"
},
"roleId":{
"type":"string",
"description":"Related role UUID, if available.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"Date/time of this version's start (ISO 8601).",
"format":"date-time",
"example":"2021-01-01T00:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"Date/time this version was replaced (ISO 8601).",
"format":"date-time",
"example":"2023-12-31T23:59:59Z"
},
"operationType":{
"type":"string",
"description":"The operation that caused this change (CREATE, UPDATE, DELETE).",
"example":"UPDATE"
},
"userId":{
"type":"string",
"description":"UUID of the user responsible for this change.",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number",
"description":"Version of the role object.",
"example":9
},
"softwareVersionNumber":{
"type":"number",
"description":"Version of the Clinical One software.",
"example":4
},
"reason":{
"type":"string",
"description":"Reason for the change.",
"example":"Role name changed due to protocol amendment."
},
"comment":{
"type":"string",
"description":"Additional comments relevant to this change.",
"example":"Role was updated by system admin."
},
"studyRoleVersion":{
"type":"string",
"description":"Version string for this study role entity.",
"example":"v2.2"
}
},
"description":"V2: Parameters for a study role, reflecting all entity and version metadata for audit and tracking.",
"example":{
"id":"648C2FC0EA7E4F5B925F7A4FABCFFF04",
"studyRoleId":"B931A89223C2425EAF9574EBA59455CF",
"studyRoleName":"MONITOR",
"studyRoleDesc":"Monitor role grants viewing and edit capabilities.",
"studyRoleType":"SITE",
"studyRoleStatus":"ACTIVE",
"studyRoleCreationType":"AUTO",
"studyId":"37F6B1958D4B4C42A1F5D3B148651073",
"roleId":"E622F2E99B2740C785A927B16A5BDA1A",
"versionStart":"2021-01-01T00:00:00.000Z",
"versionEnd":"2023-12-31T23:59:59.000Z",
"operationType":"UPDATE",
"userId":"C2C1C99E3EF74650B989F2C53177B29E",
"objectVersionNumber":9,
"softwareVersionNumber":4,
"reason":"Role name changed due to protocol amendment.",
"comment":"Role was updated by system admin.",
"studyRoleVersion":"v2.2"
}
},
"DisplayDepotDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the depot.",
"example":"CEE624A4E7EB43059C6AEC24673A288B"
},
"depotName":{
"type":"string",
"description":"Name of the depot.",
"example":"DepotA"
}
},
"description":"Represents a clinical depot.",
"example":{
"id":"CEE624A4E7EB43059C6AEC24673A288B",
"depotName":"DepotA"
}
},
"DisplayDepotsListDto":{
"type":"object",
"properties":{
"allDepots":{
"type":"boolean",
"description":"Whether all depots are associated.",
"example":false
},
"associatedDepots":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the depot.",
"example":"CEE624A4E7EB43059C6AEC24673A288B"
},
"depotName":{
"type":"string",
"description":"Name of the depot.",
"example":"DepotA"
}
},
"description":"Represents a clinical depot.",
"example":{
"id":"CEE624A4E7EB43059C6AEC24673A288B",
"depotName":"DepotA"
}
}
},
"description":"List of depots assigned to a user.",
"example":{
"allDepots":false,
"associatedDepots":[
{
"id":"CEE624A4E7EB43059C6AEC24673A288B",
"depotName":"DepotA"
}
]
}
},
"DisplaySiteDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the site.",
"format":"uuid"
},
"siteName":{
"type":"string",
"description":"Name of the site.",
"example":"SiteA"
},
"roleName":{
"type":"string",
"writeOnly":true
}
},
"description":"Represents a clinical trial site.",
"example":{
"id":"946E7D36031941CCA39CD2B2CFF2899B",
"siteName":"SiteA"
}
},
"DisplaySitesListDto":{
"type":"object",
"properties":{
"allSites":{
"type":"boolean",
"description":"Whether all sites are associated.",
"example":false
},
"associatedSites":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the site.",
"format":"uuid"
},
"siteName":{
"type":"string",
"description":"Name of the site.",
"example":"SiteA"
},
"roleName":{
"type":"string",
"writeOnly":true
}
},
"description":"Represents a clinical trial site.",
"example":{
"id":"946E7D36031941CCA39CD2B2CFF2899B",
"siteName":"SiteA"
}
}
},
"description":"List of sites assigned to a user.",
"example":{
"allSites":false,
"associatedSites":[
{
"id":"946E7D36031941CCA39CD2B2CFF2899B",
"siteName":"SiteA"
},
{
"id":"FE8925CFA8A74193A2E8D8326E7FEA88",
"siteName":"SiteB"
}
]
}
},
"DisplayStudyRoleDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the study role.",
"format":"uuid"
},
"roleName":{
"type":"string"
}
},
"description":"Represents a study-level role for a user.",
"example":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"studyRoleName":"LEAD_INVESTIGATOR"
}
},
"DisplayUserModeRoleListDtoV2":{
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"The mode the user is assigned to within a study (e.g., active, design, test, training).",
"example":"active"
},
"roles":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for this user-role association.",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Name of the role assigned to the user.",
"example":"STUDY_MANAGER"
}
},
"description":"Associates a user with a global role.",
"example":{
"id":"A519EF3C2B73455390CFF812AFF61519",
"roleName":"STUDY_MANAGER"
}
},
"studyRole":{
"$ref":"#/components/schemas/DisplayStudyRoleDto"
},
"sites":{
"$ref":"#/components/schemas/DisplaySitesListDto"
},
"depots":{
"$ref":"#/components/schemas/DisplayDepotsListDto"
}
},
"description":"Represents a user mode assignment with site, role and depot details.",
"example":{
"modeName":"active",
"roles":[
{
"id":"F7A0E5390A1F43A9AF5346EB88AC921A",
"roleName":"Rule Designer"
},
{
"id":"EA0D45A19A6E45CDAAD5F2DB7BD4E104",
"roleName":"Site User"
}
],
"studyRole":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"studyRoleName":"LEAD_INVESTIGATOR"
},
"sites":{
"allSites":false,
"associatedSites":[
{
"id":"946E7D36031941CCA39CD2B2CFF2899B",
"siteName":"SiteA"
},
{
"id":"FE8925CFA8A74193A2E8D8326E7FEA88",
"siteName":"SiteB"
}
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
{
"id":"CEE624A4E7EB43059C6AEC24673A288B",
"depotName":"DepotA"
}
]
}
}
},
"DisplayUserStudyModeRoleListDtoV2":{
"type":"object",
"properties":{
"effectiveStart":{
"type":"string",
"description":"The effective start date-time for this user-study association.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"effectiveEnd":{
"type":"string",
"description":"The effective end date-time for this user-study association.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
},
"modes":{
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"The mode the user is assigned to within a study (e.g., active, design, test, training).",
"example":"active"
},
"roles":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for this user-role association.",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Name of the role assigned to the user.",
"example":"STUDY_MANAGER"
}
},
"description":"Associates a user with a global role.",
"example":{
"id":"A519EF3C2B73455390CFF812AFF61519",
"roleName":"STUDY_MANAGER"
}
},
"studyRole":{
"$ref":"#/components/schemas/DisplayStudyRoleDto"
},
"sites":{
"$ref":"#/components/schemas/DisplaySitesListDto"
},
"depots":{
"$ref":"#/components/schemas/DisplayDepotsListDto"
}
},
"description":"Represents a user mode assignment with site, role and depot details.",
"example":{
"modeName":"active",
"roles":[
{
"id":"F7A0E5390A1F43A9AF5346EB88AC921A",
"roleName":"Rule Designer"
},
{
"id":"EA0D45A19A6E45CDAAD5F2DB7BD4E104",
"roleName":"Site User"
}
],
"studyRole":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"studyRoleName":"LEAD_INVESTIGATOR"
},
"sites":{
"allSites":false,
"associatedSites":[
{
"id":"946E7D36031941CCA39CD2B2CFF2899B",
"siteName":"SiteA"
},
{
"id":"FE8925CFA8A74193A2E8D8326E7FEA88",
"siteName":"SiteB"
}
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
{
"id":"CEE624A4E7EB43059C6AEC24673A288B",
"depotName":"DepotA"
}
]
}
}
}
},
"description":"Represents a user's study mode roles with effective period and modes.",
"example":{
"effectiveStart":"2020-06-17T10:15:30.000Z",
"effectiveEnd":"2025-06-17T10:15:30.000Z",
"modes":[
{
"modeName":"active",
"roles":[
{
"id":"F7A0E5390A1F43A9AF5346EB88AC921A",
"roleName":"Rule Designer"
},
{
"id":"EA0D45A19A6E45CDAAD5F2DB7BD4E104",
"roleName":"Site User"
}
],
"studyRole":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"studyRoleName":"LEAD_INVESTIGATOR"
},
"sites":{
"allSites":false,
"associatedSites":[
{
"id":"946E7D36031941CCA39CD2B2CFF2899B",
"siteName":"SiteA"
},
{
"id":"FE8925CFA8A74193A2E8D8326E7FEA88",
"siteName":"SiteB"
}
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
{
"id":"CEE624A4E7EB43059C6AEC24673A288B",
"depotName":"DepotA"
}
]
}
}
]
}
},
"UpdateUserModeRoleListDtoV2":{
"required":[
"modeName"
],
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"The mode the user is assigned to within a study (e.g., active, design, test, training).",
"example":"active"
},
"studyRoleId":{
"type":"string",
"description":"ID of the study role for user assignment.",
"format":"uuid"
},
"sites":{
"$ref":"#/components/schemas/SitesListDto"
},
"depots":{
"$ref":"#/components/schemas/DepotsListDto"
}
},
"description":"Update details for a user mode assignment in request payload.",
"example":{
"modeName":"active",
"studyRoleId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"sites":{
"allSites":false,
"associatedSites":[
"946E7D36031941CCA39CD2B2CFF2899B",
"FE8925CFA8A74193A2E8D8326E7FEA88"
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
"CEE624A4E7EB43059C6AEC24673A288B"
]
}
}
},
"UpdateUserStudyModeRoleListDtoV2":{
"required":[
"effectiveEnd",
"effectiveStart",
"modes"
],
"type":"object",
"properties":{
"effectiveStart":{
"type":"string",
"description":"The effective start date-time for this user-study role update.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"effectiveEnd":{
"type":"string",
"description":"The effective end date-time for this user-study role update.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
},
"modes":{
"required":[
"modeName"
],
"type":"object",
"properties":{
"modeName":{
"type":"string",
"description":"The mode the user is assigned to within a study (e.g., active, design, test, training).",
"example":"active"
},
"studyRoleId":{
"type":"string",
"description":"ID of the study role for user assignment.",
"format":"uuid"
},
"sites":{
"$ref":"#/components/schemas/SitesListDto"
},
"depots":{
"$ref":"#/components/schemas/DepotsListDto"
}
},
"description":"Update details for a user mode assignment in request payload.",
"example":{
"modeName":"active",
"studyRoleId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"sites":{
"allSites":false,
"associatedSites":[
"946E7D36031941CCA39CD2B2CFF2899B",
"FE8925CFA8A74193A2E8D8326E7FEA88"
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
"CEE624A4E7EB43059C6AEC24673A288B"
]
}
}
}
},
"description":"Request payload to update user study mode roles.",
"example":{
"effectiveStart":"2020-06-17T10:15:30.000Z",
"effectiveEnd":"2025-06-17T10:15:30.000Z",
"modes":[
{
"modeName":"active",
"studyRoleId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"sites":{
"allSites":false,
"associatedSites":[
"946E7D36031941CCA39CD2B2CFF2899B",
"FE8925CFA8A74193A2E8D8326E7FEA88"
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
"CEE624A4E7EB43059C6AEC24673A288B"
]
}
}
]
}
},
"DisplayGlobalRoleUserDtoV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"firstName":{
"type":"string"
},
"lastName":{
"type":"string"
},
"userName":{
"type":"string"
},
"lastAccess":{
"type":"string",
"format":"date-time"
},
"globalroles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DisplayUserRoleDtoV2"
}
},
"versionStart":{
"type":"string",
"description":"Start date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2020-06-17T10:15:30Z"
},
"versionEnd":{
"type":"string",
"description":"End date for the object's version validity. ISO 8601 format.",
"format":"date-time",
"example":"2025-06-17T10:15:30Z"
}
}
},
"DisplayGlobalRoleUserListDtoV2":{
"type":"object",
"properties":{
"usersFound":{
"type":"integer",
"format":"int32"
},
"firstUserReturned":{
"type":"integer",
"format":"int32"
},
"usersReturned":{
"type":"integer",
"format":"int32"
},
"globalusers":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DisplayGlobalRoleUserDtoV2"
}
}
}
},
"DisplayRoleDto":{
"required":[
"id",
"objectVersionNumber",
"roleCategory",
"roleCategoryLabel",
"roleName",
"roleNameLabel",
"roleSubCategoryLabel",
"roleType"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"roleType":{
"type":"string"
},
"roleCategory":{
"type":"string"
},
"roleSubCategory":{
"type":"string"
},
"unblinded":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"roleNameLabel":{
"type":"string"
},
"roleCategoryLabel":{
"type":"string"
},
"roleSubCategoryLabel":{
"type":"string"
}
}
},
"RespDisplayRoleDto":{
"required":[
"id",
"objectVersionNumber",
"roleCategory",
"roleCategoryLabel",
"roleName",
"roleNameLabel",
"roleSubCategoryLabel",
"roleType"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"roleType":{
"type":"string"
},
"roleCategory":{
"type":"string"
},
"roleSubCategory":{
"type":"string"
},
"unblinded":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"roleNameLabel":{
"type":"string"
},
"roleCategoryLabel":{
"type":"string"
},
"roleSubCategoryLabel":{
"type":"string"
}
}
},
"DisplayStudyUserListDtoV2":{
"title":"DisplayStudyUserListDtoV2",
"type":"object",
"properties":{
"usersFound":{
"type":"integer",
"description":"The total number of users found matching the query.",
"format":"int32",
"example":2
},
"firstUserReturned":{
"type":"integer",
"description":"Index of the first user returned in this page.",
"format":"int32",
"example":1
},
"usersReturned":{
"type":"integer",
"description":"How many users are present in this response.",
"format":"int32",
"example":2
},
"users":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier of the user within the study.",
"format":"uuid"
},
"firstName":{
"type":"string",
"description":"User's first name.",
"example":"John"
},
"lastName":{
"type":"string",
"description":"User's last name.",
"example":"Doe"
},
"email":{
"type":"string",
"description":"User's email address.",
"format":"email",
"example":"studyuser@example.com"
},
"phone":{
"type":"string",
"description":"User's phone number.",
"example":"+1-222-333-4444"
},
"userName":{
"type":"string",
"description":"Username used for authentication.",
"example":"jdoe"
},
"lastAccess":{
"type":"string",
"description":"Timestamp (ISO8601/Z) when user last accessed the study.",
"format":"date-time",
"example":"2022-06-20T13:51:51Z"
},
"effectiveStart":{
"type":"string",
"description":"Effective start date for user's study access (ISO8601/Z).",
"format":"date-time",
"example":"2021-01-17T01:00:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"Effective end date for user's study access (ISO8601/Z).",
"format":"date-time",
"example":"2025-01-17T01:00:00Z"
},
"roles":{
"type":"array",
"description":"Roles assigned to the user within the study.",
"example":[
"Rule Designer",
"Site User"
],
"items":{
"type":"string",
"description":"Roles assigned to the user within the study.",
"example":"[\"Rule Designer\",\"Site User\"]"
}
},
"sites":{
"$ref":"#/components/schemas/DisplaySiteNamesListDto"
},
"depots":{
"$ref":"#/components/schemas/DisplayDepotNamesListDto"
}
},
"description":"Version 2: Extends DisplayStudyUserDto to include user email and phone information.",
"example":{
"id":"7DC8B36EA5C04E1F9D11C0E5F3FFF789",
"firstName":"Jane",
"lastName":"Smith",
"userName":"jsmith",
"lastAccess":"2023-12-19T12:42:11.000Z",
"effectiveStart":"2021-06-11T10:00:00.000Z",
"effectiveEnd":"2025-09-21T10:00:00.000Z",
"roles":[
"Site User",
"Rule Designer"
],
"sites":{
"allSites":false,
"associatedSites":[
"7DC8B36EA5C04E1F9D11C0E5F3FFF780",
"6DC8B36EA5C04E1F9D11C0E5F3FFF789"
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
"7DC8B36EA5W04E1F9D11C0E5F3FFF789"
]
},
"email":"studyuser@example.com",
"phone":"+1-222-333-4444"
}
}
},
"description":"Contains list of users information"
},
"RespStudyRoleDtoParams":{
"required":[
"studyRoleCreationType",
"studyRoleDesc",
"studyRoleDescLabel",
"studyRoleId",
"studyRoleName",
"studyRoleNameLabel",
"studyRoleStatus",
"studyRoleType",
"studyRoleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"studyRoleName":{
"type":"string"
},
"studyRoleDesc":{
"type":"string"
},
"studyRoleType":{
"type":"string"
},
"studyRoleStatus":{
"type":"string"
},
"studyRoleNameLabel":{
"type":"string"
},
"studyRoleDescLabel":{
"type":"string"
},
"studyRoleTypeLabel":{
"type":"string"
},
"studyRoleCreationType":{
"type":"string"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"studyRoleVersion":{
"type":"string"
},
"roles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RoleDtoParams"
}
}
}
},
"RoleDtoParams":{
"required":[
"roleCategory",
"roleCategoryLabel",
"roleId",
"roleName",
"roleNameLabel",
"roleType",
"roleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"roleType":{
"type":"string"
},
"roleCategory":{
"type":"string"
},
"roleSubCategory":{
"type":"string"
},
"roleNameLabel":{
"type":"string"
},
"roleTypeLabel":{
"type":"string"
},
"roleCategoryLabel":{
"type":"string"
},
"roleSubCategoryLabel":{
"type":"string"
},
"unblinded":{
"type":"string"
},
"roleSeq":{
"type":"number"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
}
},
"DisplayModeDto":{
"type":"object",
"properties":{
"modeId":{
"type":"string",
"description":"Unique identifier for the mode.",
"format":"uuid"
},
"modeName":{
"type":"string",
"description":"Display name of the mode (e.g., active, design, test, training).",
"example":"active"
},
"modeType":{
"type":"string",
"description":"Type of the mode.",
"example":"main"
},
"modeSeq":{
"type":"number",
"description":"Sequence/order number of the mode.",
"format":"int32",
"example":1
},
"versionStart":{
"type":"string",
"description":"Start date/time for this particular mode version.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"End date/time for this particular mode version.",
"format":"date-time",
"example":"2024-01-01T09:00:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type (add, update, delete).",
"example":"add"
},
"userId":{
"type":"string",
"description":"User identifier who performed the operation.",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number",
"description":"Object version tracking number.",
"format":"int32",
"example":2
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version for this mode definition.",
"format":"int32",
"example":3
},
"reason":{
"type":"string",
"description":"Reason for operation or mode change.",
"example":"Scheduled migration"
},
"comment":{
"type":"string",
"description":"Free-text comment for the mode assignment.",
"example":"Automatically assigned at user creation."
}
},
"description":"Represents a study assignment mode, including metadata and display attributes.",
"example":{
"modeId":"CFA1426E4B9646299E692D9403AC5019",
"modeName":"active",
"modeType":"main",
"modeSeq":1,
"versionStart":"2023-01-01T09:00:00.000Z",
"versionEnd":"2024-01-01T09:00:00.000Z",
"operationType":"add",
"userId":"BE2376BB5B0D469EBFA78DE98D954327",
"objectVersionNumber":2,
"softwareVersionNumber":3,
"reason":"Scheduled migration",
"comment":"Automatically assigned at user creation."
}
},
"DisplayUserModeStudyRolesListDtoV3":{
"type":"object",
"properties":{
"mode":{
"$ref":"#/components/schemas/DisplayModeDto"
},
"studyRoles":{
"required":[
"studyRoleCreationType",
"studyRoleDesc",
"studyRoleId",
"studyRoleName",
"studyRoleStatus",
"studyRoleType"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"description":"The study to which the role assignment applies.",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"description":"User ID of person being granted the study role.",
"format":"uuid"
},
"modeId":{
"type":"string",
"description":"The study assignment mode for this role.",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"description":"Unique identifier for the study role assigned.",
"format":"uuid"
},
"roleId":{
"type":"string",
"description":"Application role ID (if applicable).",
"format":"uuid"
},
"studyRoleName":{
"type":"string",
"description":"Display name of the study role.",
"example":"LEAD_INVESTIGATOR"
},
"studyRoleDesc":{
"type":"string",
"description":"Description of the study role.",
"example":"Main PI for the study"
},
"studyRoleType":{
"type":"string",
"description":"Type of the study role.",
"example":"Primary"
},
"studyRoleStatus":{
"type":"string",
"description":"Current status of the study role.",
"example":"ENABLED"
},
"studyRoleCreationType":{
"type":"string",
"description":"Creation type for the study role.",
"example":"auto"
},
"effectiveStart":{
"type":"string",
"description":"Start timestamp for when the study role is effective.",
"format":"date-time",
"example":"2021-05-01T08:30:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"End timestamp for when the study role is no longer effective.",
"format":"date-time",
"example":"2025-01-01T08:30:00Z"
},
"versionStart":{
"type":"string",
"description":"Start version timestamp for this study role definition.",
"format":"date-time",
"example":"2021-04-01T08:30:00Z"
},
"versionEnd":{
"type":"string",
"description":"End version timestamp for this study role definition.",
"format":"date-time",
"example":"2026-01-01T08:30:00Z"
},
"operationType":{
"type":"string",
"description":"The operation performed on the study role record.",
"example":"add"
},
"userId":{
"type":"string",
"description":"User executing the operation.",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number",
"description":"Version control for the object.",
"format":"int32",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software schema version for the study role.",
"format":"int32",
"example":2
},
"reason":{
"type":"string",
"description":"Reason for the study role assignment.",
"example":"Initial study role assignment"
},
"comment":{
"type":"string",
"description":"Additional details or comments.",
"example":"Added due to auto-enrollment"
},
"studyRoleVersion":{
"type":"string",
"description":"Business/version tag for this study role.",
"example":"v3.5"
},
"roles":{
"required":[
"id",
"roleCategory",
"roleName",
"roleType"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"id":{
"type":"string",
"description":"Unique identifier of the application role.",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Human-readable role name.",
"example":"VIEWER"
},
"roleType":{
"type":"string",
"description":"Type of the role (e.g., Application, Study, Global).",
"example":"Application"
},
"roleCategory":{
"type":"string",
"description":"Business category of the role.",
"example":"Study"
},
"roleSubCategory":{
"type":"string"
},
"unblinded":{
"type":"string",
"description":"Indicates if the role is unblinded (Y/N).",
"example":"Y"
},
"roleSeq":{
"type":"number",
"description":"Role sequence/order in assignment.",
"format":"int32",
"example":1
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents an application role and its assignment attributes, including identifiers and display information.",
"example":{
"id":"37EFDC494C944E58ADAC8DA952A2C60C",
"roleName":"Site User",
"roleType":"Application",
"roleCategory":"Study",
"roleSeq":1,
"unblinded":"Y"
}
}
},
"description":"Study role assignment details for a user, including all attributes and versioning for v3 API.",
"example":{
"studyId":"C66E641816EF4E2798AFFEEDD8D5B1E8",
"authorizedUserId":"A6706B7CC5904EF79F9D5AE35668D175",
"modeId":"4A3EDAA8292245C6AA01D8975A7D46E1",
"studyRoleId":"68B1C4F7CA2E7C90AFA8B5D8F18A5B4F",
"roleId":"5E40DF7E44E74FED91B1565DCF4FBC8A",
"studyRoleName":"LEAD_INVESTIGATOR",
"studyRoleDesc":"Main PI for the study",
"studyRoleType":"Primary",
"studyRoleStatus":"ENABLED",
"studyRoleCreationType":"auto",
"effectiveStart":"2021-05-01T08:30:00.000Z",
"effectiveEnd":"2025-01-01T08:30:00.000Z",
"versionStart":"2021-04-01T08:30:00.000Z",
"versionEnd":"2026-01-01T08:30:00.000Z",
"operationType":"add",
"userId":"24BADE98851C492A8C5D29DD8F9B1E36",
"objectVersionNumber":1,
"softwareVersionNumber":2,
"reason":"Initial study role assignment",
"comment":"Added due to auto-enrollment",
"studyRoleVersion":"v3.5",
"roles":[
{
"id":"37EFDC494C944E58ADAC8DA952A2C60C",
"roleName":"Site User"
}
]
}
},
"roles":{
"required":[
"id",
"roleCategory",
"roleName",
"roleType"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"id":{
"type":"string",
"description":"Unique identifier of the application role.",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Human-readable role name.",
"example":"VIEWER"
},
"roleType":{
"type":"string",
"description":"Type of the role (e.g., Application, Study, Global).",
"example":"Application"
},
"roleCategory":{
"type":"string",
"description":"Business category of the role.",
"example":"Study"
},
"roleSubCategory":{
"type":"string"
},
"unblinded":{
"type":"string",
"description":"Indicates if the role is unblinded (Y/N).",
"example":"Y"
},
"roleSeq":{
"type":"number",
"description":"Role sequence/order in assignment.",
"format":"int32",
"example":1
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents an application role and its assignment attributes, including identifiers and display information.",
"example":{
"id":"37EFDC494C944E58ADAC8DA952A2C60C",
"roleName":"Site User",
"roleType":"Application",
"roleCategory":"Study",
"roleSeq":1,
"unblinded":"Y"
}
},
"sites":{
"type":"object",
"properties":{
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"mode":{
"type":"string"
},
"nameSeq":{
"type":"number"
},
"name":{
"type":"string",
"description":"Name for the mapping group (e.g., 'associatedSites', 'associatedDepots', 'allSites', 'allDepots').",
"example":"associatedSites"
},
"value":{
"type":"string",
"description":"ID or logical value mapped to this property.",
"example":"90C93FDF399E4DED99A0B7EF4E189C32"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents a user's mapping to sites or depots for a study/mode.",
"example":{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32",
"studyId":"45A27BCC19D741C58AF11698753BDE5A",
"authorizedUserId":"47C0B2D48F2544E6B848FB6923D9531F",
"mode":"active"
}
},
"depots":{
"type":"object",
"properties":{
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"mode":{
"type":"string"
},
"nameSeq":{
"type":"number"
},
"name":{
"type":"string",
"description":"Name for the mapping group (e.g., 'associatedSites', 'associatedDepots', 'allSites', 'allDepots').",
"example":"associatedSites"
},
"value":{
"type":"string",
"description":"ID or logical value mapped to this property.",
"example":"90C93FDF399E4DED99A0B7EF4E189C32"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents a user's mapping to sites or depots for a study/mode.",
"example":{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32",
"studyId":"45A27BCC19D741C58AF11698753BDE5A",
"authorizedUserId":"47C0B2D48F2544E6B848FB6923D9531F",
"mode":"active"
}
}
},
"description":"Represents a user's mode assignment in v3, including roles, study roles, sites and depots.",
"example":{
"mode":{
"modeId":"CFA1426E4B9646299E692D9403AC5019",
"modeName":"active",
"modeType":"main",
"modeSeq":1,
"versionStart":"2023-01-01T09:00:00.000Z",
"versionEnd":"2024-01-01T09:00:00.000Z",
"operationType":"add",
"userId":"BE2376BB5B0D469EBFA78DE98D954327",
"objectVersionNumber":2,
"softwareVersionNumber":3,
"reason":"Scheduled migration",
"comment":"Automatically assigned at user creation."
},
"studyRoles":[
{
"studyId":"C66E641816EF4E2798AFFEEDD8D5B1E8",
"authorizedUserId":"A6706B7CC5904EF79F9D5AE35668D175",
"modeId":"4A3EDAA8292245C6AA01D8975A7D46E1",
"studyRoleId":"68B1C4F7CA2E7C90AFA8B5D8F18A5B4F",
"roleId":"5E40DF7E44E74FED91B1565DCF4FBC8A",
"studyRoleName":"LEAD_INVESTIGATOR",
"studyRoleDesc":"Main PI for the study",
"studyRoleType":"Primary",
"studyRoleStatus":"ENABLED",
"studyRoleCreationType":"auto",
"effectiveStart":"2021-05-01T08:30:00.000Z",
"effectiveEnd":"2025-01-01T08:30:00.000Z",
"versionStart":"2021-04-01T08:30:00.000Z",
"versionEnd":"2026-01-01T08:30:00.000Z",
"operationType":"add",
"userId":"24BADE98851C492A8C5D29DD8F9B1E36",
"objectVersionNumber":1,
"softwareVersionNumber":2,
"reason":"Initial study role assignment",
"comment":"Added due to auto-enrollment",
"studyRoleVersion":"v3.5",
"roles":[
{
"id":"37EFDC494C944E58ADAC8DA952A2C60C",
"roleName":"Site User",
"roleType":"Application",
"roleCategory":"Study",
"roleSeq":1,
"unblinded":"Y"
}
]
}
],
"roles":[
{
"id":"7D96866A5B1A43388B780C6D15E27ACD",
"roleName":"MONITOR",
"roleType":"Application",
"roleCategory":"Monitor",
"roleSeq":2,
"unblinded":"N"
}
],
"sites":[
{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32"
},
{
"name":"associatedSites",
"value":"8188DBB5B5A9486B9767ED7263DA626E"
},
{
"name":"allSites",
"value":"false"
}
],
"depots":[
{
"name":"associatedDepots",
"value":"BD561E1A5BD748FFA3505A2B2E493C3A"
},
{
"name":"allDepots",
"value":"false"
}
]
}
},
"DisplayUserSitesDepotsDto":{
"type":"object",
"properties":{
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"mode":{
"type":"string"
},
"nameSeq":{
"type":"number"
},
"name":{
"type":"string",
"description":"Name for the mapping group (e.g., 'associatedSites', 'associatedDepots', 'allSites', 'allDepots').",
"example":"associatedSites"
},
"value":{
"type":"string",
"description":"ID or logical value mapped to this property.",
"example":"90C93FDF399E4DED99A0B7EF4E189C32"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents a user's mapping to sites or depots for a study/mode.",
"example":{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32",
"studyId":"45A27BCC19D741C58AF11698753BDE5A",
"authorizedUserId":"47C0B2D48F2544E6B848FB6923D9531F",
"mode":"active"
}
},
"StudyRoleDtoParamsV3":{
"required":[
"studyRoleCreationType",
"studyRoleDesc",
"studyRoleId",
"studyRoleName",
"studyRoleStatus",
"studyRoleType"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"description":"The study to which the role assignment applies.",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"description":"User ID of person being granted the study role.",
"format":"uuid"
},
"modeId":{
"type":"string",
"description":"The study assignment mode for this role.",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"description":"Unique identifier for the study role assigned.",
"format":"uuid"
},
"roleId":{
"type":"string",
"description":"Application role ID (if applicable).",
"format":"uuid"
},
"studyRoleName":{
"type":"string",
"description":"Display name of the study role.",
"example":"LEAD_INVESTIGATOR"
},
"studyRoleDesc":{
"type":"string",
"description":"Description of the study role.",
"example":"Main PI for the study"
},
"studyRoleType":{
"type":"string",
"description":"Type of the study role.",
"example":"Primary"
},
"studyRoleStatus":{
"type":"string",
"description":"Current status of the study role.",
"example":"ENABLED"
},
"studyRoleCreationType":{
"type":"string",
"description":"Creation type for the study role.",
"example":"auto"
},
"effectiveStart":{
"type":"string",
"description":"Start timestamp for when the study role is effective.",
"format":"date-time",
"example":"2021-05-01T08:30:00Z"
},
"effectiveEnd":{
"type":"string",
"description":"End timestamp for when the study role is no longer effective.",
"format":"date-time",
"example":"2025-01-01T08:30:00Z"
},
"versionStart":{
"type":"string",
"description":"Start version timestamp for this study role definition.",
"format":"date-time",
"example":"2021-04-01T08:30:00Z"
},
"versionEnd":{
"type":"string",
"description":"End version timestamp for this study role definition.",
"format":"date-time",
"example":"2026-01-01T08:30:00Z"
},
"operationType":{
"type":"string",
"description":"The operation performed on the study role record.",
"example":"add"
},
"userId":{
"type":"string",
"description":"User executing the operation.",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number",
"description":"Version control for the object.",
"format":"int32",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software schema version for the study role.",
"format":"int32",
"example":2
},
"reason":{
"type":"string",
"description":"Reason for the study role assignment.",
"example":"Initial study role assignment"
},
"comment":{
"type":"string",
"description":"Additional details or comments.",
"example":"Added due to auto-enrollment"
},
"studyRoleVersion":{
"type":"string",
"description":"Business/version tag for this study role.",
"example":"v3.5"
},
"roles":{
"required":[
"id",
"roleCategory",
"roleName",
"roleType"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"id":{
"type":"string",
"description":"Unique identifier of the application role.",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string",
"description":"Human-readable role name.",
"example":"VIEWER"
},
"roleType":{
"type":"string",
"description":"Type of the role (e.g., Application, Study, Global).",
"example":"Application"
},
"roleCategory":{
"type":"string",
"description":"Business category of the role.",
"example":"Study"
},
"roleSubCategory":{
"type":"string"
},
"unblinded":{
"type":"string",
"description":"Indicates if the role is unblinded (Y/N).",
"example":"Y"
},
"roleSeq":{
"type":"number",
"description":"Role sequence/order in assignment.",
"format":"int32",
"example":1
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents an application role and its assignment attributes, including identifiers and display information.",
"example":{
"id":"37EFDC494C944E58ADAC8DA952A2C60C",
"roleName":"Site User",
"roleType":"Application",
"roleCategory":"Study",
"roleSeq":1,
"unblinded":"Y"
}
}
},
"description":"Study role assignment details for a user, including all attributes and versioning for v3 API.",
"example":{
"studyId":"C66E641816EF4E2798AFFEEDD8D5B1E8",
"authorizedUserId":"A6706B7CC5904EF79F9D5AE35668D175",
"modeId":"4A3EDAA8292245C6AA01D8975A7D46E1",
"studyRoleId":"68B1C4F7CA2E7C90AFA8B5D8F18A5B4F",
"roleId":"5E40DF7E44E74FED91B1565DCF4FBC8A",
"studyRoleName":"LEAD_INVESTIGATOR",
"studyRoleDesc":"Main PI for the study",
"studyRoleType":"Primary",
"studyRoleStatus":"ENABLED",
"studyRoleCreationType":"auto",
"effectiveStart":"2021-05-01T08:30:00.000Z",
"effectiveEnd":"2025-01-01T08:30:00.000Z",
"versionStart":"2021-04-01T08:30:00.000Z",
"versionEnd":"2026-01-01T08:30:00.000Z",
"operationType":"add",
"userId":"24BADE98851C492A8C5D29DD8F9B1E36",
"objectVersionNumber":1,
"softwareVersionNumber":2,
"reason":"Initial study role assignment",
"comment":"Added due to auto-enrollment",
"studyRoleVersion":"v3.5",
"roles":[
{
"id":"37EFDC494C944E58ADAC8DA952A2C60C",
"roleName":"Site User"
}
]
}
},
"DisplayUserStudyAccessDetails":{
"type":"object",
"properties":{
"lastAccess":{
"type":"string",
"description":"UTC ISO 8601 timestamp for when the user last accessed this study.",
"format":"date-time",
"example":"2024-10-26T18:41:00Z"
},
"userStudyModeDetails":{
"type":"object",
"properties":{
"mode":{
"$ref":"#/components/schemas/DisplayModeDto"
},
"studyRoles":{
"required":[
"studyRoleCreationType",
"studyRoleDesc",
"studyRoleDescLabel",
"studyRoleId",
"studyRoleName",
"studyRoleNameLabel",
"studyRoleStatus",
"studyRoleType",
"studyRoleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"studyRoleName":{
"type":"string"
},
"studyRoleDesc":{
"type":"string"
},
"studyRoleType":{
"type":"string"
},
"studyRoleStatus":{
"type":"string"
},
"studyRoleNameLabel":{
"type":"string"
},
"studyRoleDescLabel":{
"type":"string"
},
"studyRoleTypeLabel":{
"type":"string"
},
"studyRoleCreationType":{
"type":"string"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"studyRoleVersion":{
"type":"string"
},
"roles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RoleDtoParams"
}
}
},
"description":"List of study-level roles assigned to this user in this mode."
},
"roles":{
"required":[
"roleCategory",
"roleCategoryLabel",
"roleId",
"roleName",
"roleNameLabel",
"roleType",
"roleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"roleType":{
"type":"string"
},
"roleCategory":{
"type":"string"
},
"roleSubCategory":{
"type":"string"
},
"roleNameLabel":{
"type":"string"
},
"roleTypeLabel":{
"type":"string"
},
"roleCategoryLabel":{
"type":"string"
},
"roleSubCategoryLabel":{
"type":"string"
},
"unblinded":{
"type":"string"
},
"roleSeq":{
"type":"number"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"List of global roles with ID and roleName, assigned to the user in this mode."
},
"sites":{
"type":"object",
"properties":{
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"mode":{
"type":"string"
},
"nameSeq":{
"type":"number"
},
"name":{
"type":"string",
"description":"Name for the mapping group (e.g., 'associatedSites', 'associatedDepots', 'allSites', 'allDepots').",
"example":"associatedSites"
},
"value":{
"type":"string",
"description":"ID or logical value mapped to this property.",
"example":"90C93FDF399E4DED99A0B7EF4E189C32"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents a user's mapping to sites or depots for a study/mode.",
"example":{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32",
"studyId":"45A27BCC19D741C58AF11698753BDE5A",
"authorizedUserId":"47C0B2D48F2544E6B848FB6923D9531F",
"mode":"active"
}
},
"depots":{
"type":"object",
"properties":{
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"mode":{
"type":"string"
},
"nameSeq":{
"type":"number"
},
"name":{
"type":"string",
"description":"Name for the mapping group (e.g., 'associatedSites', 'associatedDepots', 'allSites', 'allDepots').",
"example":"associatedSites"
},
"value":{
"type":"string",
"description":"ID or logical value mapped to this property.",
"example":"90C93FDF399E4DED99A0B7EF4E189C32"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents a user's mapping to sites or depots for a study/mode.",
"example":{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32",
"studyId":"45A27BCC19D741C58AF11698753BDE5A",
"authorizedUserId":"47C0B2D48F2544E6B848FB6923D9531F",
"mode":"active"
}
}
},
"description":"Assignment and role details for a user in a specific study mode, including role, studyRole, sites, and depots assignments.",
"example":{
"mode":{
"modeName":"active",
"effectiveStart":"2021-01-01T00:00:00.000Z",
"effectiveEnd":"2026-01-01T00:00:00.000Z"
},
"studyRoles":[
{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"studyRoleName":"LEAD_INVESTIGATOR"
}
],
"roles":[
{
"roleId":"A519EF3C2B73455390CFF812AFF61519",
"roleName":"Rule Designer"
},
{
"roleId":"EA0D45A19A6E45CDAAD5F2DB7BD4E104",
"roleName":"Site User"
}
],
"sites":[
{
"allSites":false,
"associatedSites":[
"946E7D36031941CCA39CD2B2CFF2899B",
"FE8925CFA8A74193A2E8D8326E7FEA88"
]
}
],
"depots":[
{
"allDepots":false,
"associatedDepots":[
"CEE624A4E7EB43059C6AEC24673A288B"
]
}
]
}
}
},
"description":"Provides a user's last access timestamp and a list of their mode/role/site/depot assignments for a study.",
"example":{
"lastAccess":"2024-10-26T18:41:00.000Z",
"userStudyModeDetails":[
{
"modeName":"active",
"effectiveStart":"2021-01-01T00:00:00.000Z",
"effectiveEnd":"2026-01-01T00:00:00.000Z",
"roles":[
{
"roleId":"A519EF3C2B73455390CFF812AFF61519",
"roleName":"Rule Designer"
},
{
"roleId":"EA0D45A19A6E45CDAAD5F2DB7BD4E104",
"roleName":"Site User"
}
],
"studyRole":{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"studyRoleName":"LEAD_INVESTIGATOR"
},
"sites":{
"allSites":false,
"associatedSites":[
"946E7D36031941CCA39CD2B2CFF2899B",
"FE8925CFA8A74193A2E8D8326E7FEA88"
]
},
"depots":{
"allDepots":false,
"associatedDepots":[
"CEE624A4E7EB43059C6AEC24673A288B"
]
}
}
]
}
},
"UserStudyModeDetails":{
"type":"object",
"properties":{
"mode":{
"$ref":"#/components/schemas/DisplayModeDto"
},
"studyRoles":{
"required":[
"studyRoleCreationType",
"studyRoleDesc",
"studyRoleDescLabel",
"studyRoleId",
"studyRoleName",
"studyRoleNameLabel",
"studyRoleStatus",
"studyRoleType",
"studyRoleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"studyRoleName":{
"type":"string"
},
"studyRoleDesc":{
"type":"string"
},
"studyRoleType":{
"type":"string"
},
"studyRoleStatus":{
"type":"string"
},
"studyRoleNameLabel":{
"type":"string"
},
"studyRoleDescLabel":{
"type":"string"
},
"studyRoleTypeLabel":{
"type":"string"
},
"studyRoleCreationType":{
"type":"string"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"studyRoleVersion":{
"type":"string"
},
"roles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RoleDtoParams"
}
}
},
"description":"List of study-level roles assigned to this user in this mode."
},
"roles":{
"required":[
"roleCategory",
"roleCategoryLabel",
"roleId",
"roleName",
"roleNameLabel",
"roleType",
"roleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"roleType":{
"type":"string"
},
"roleCategory":{
"type":"string"
},
"roleSubCategory":{
"type":"string"
},
"roleNameLabel":{
"type":"string"
},
"roleTypeLabel":{
"type":"string"
},
"roleCategoryLabel":{
"type":"string"
},
"roleSubCategoryLabel":{
"type":"string"
},
"unblinded":{
"type":"string"
},
"roleSeq":{
"type":"number"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"List of global roles with ID and roleName, assigned to the user in this mode."
},
"sites":{
"type":"object",
"properties":{
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"mode":{
"type":"string"
},
"nameSeq":{
"type":"number"
},
"name":{
"type":"string",
"description":"Name for the mapping group (e.g., 'associatedSites', 'associatedDepots', 'allSites', 'allDepots').",
"example":"associatedSites"
},
"value":{
"type":"string",
"description":"ID or logical value mapped to this property.",
"example":"90C93FDF399E4DED99A0B7EF4E189C32"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents a user's mapping to sites or depots for a study/mode.",
"example":{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32",
"studyId":"45A27BCC19D741C58AF11698753BDE5A",
"authorizedUserId":"47C0B2D48F2544E6B848FB6923D9531F",
"mode":"active"
}
},
"depots":{
"type":"object",
"properties":{
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"mode":{
"type":"string"
},
"nameSeq":{
"type":"number"
},
"name":{
"type":"string",
"description":"Name for the mapping group (e.g., 'associatedSites', 'associatedDepots', 'allSites', 'allDepots').",
"example":"associatedSites"
},
"value":{
"type":"string",
"description":"ID or logical value mapped to this property.",
"example":"90C93FDF399E4DED99A0B7EF4E189C32"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"Represents a user's mapping to sites or depots for a study/mode.",
"example":{
"name":"associatedSites",
"value":"90C93FDF399E4DED99A0B7EF4E189C32",
"studyId":"45A27BCC19D741C58AF11698753BDE5A",
"authorizedUserId":"47C0B2D48F2544E6B848FB6923D9531F",
"mode":"active"
}
}
},
"description":"Assignment and role details for a user in a specific study mode, including role, studyRole, sites, and depots assignments.",
"example":{
"mode":{
"modeName":"active",
"effectiveStart":"2021-01-01T00:00:00.000Z",
"effectiveEnd":"2026-01-01T00:00:00.000Z"
},
"studyRoles":[
{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"studyRoleName":"LEAD_INVESTIGATOR"
}
],
"roles":[
{
"roleId":"A519EF3C2B73455390CFF812AFF61519",
"roleName":"Rule Designer"
},
{
"roleId":"EA0D45A19A6E45CDAAD5F2DB7BD4E104",
"roleName":"Site User"
}
],
"sites":[
{
"allSites":false,
"associatedSites":[
"946E7D36031941CCA39CD2B2CFF2899B",
"FE8925CFA8A74193A2E8D8326E7FEA88"
]
}
],
"depots":[
{
"allDepots":false,
"associatedDepots":[
"CEE624A4E7EB43059C6AEC24673A288B"
]
}
]
}
},
"roles":{
"required":[
"roleCategory",
"roleCategoryLabel",
"roleId",
"roleName",
"roleNameLabel",
"roleType",
"roleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"rightId":{
"type":"string",
"format":"uuid"
},
"roleName":{
"type":"string"
},
"roleType":{
"type":"string"
},
"roleCategory":{
"type":"string"
},
"roleSubCategory":{
"type":"string"
},
"roleNameLabel":{
"type":"string"
},
"roleTypeLabel":{
"type":"string"
},
"roleCategoryLabel":{
"type":"string"
},
"roleSubCategoryLabel":{
"type":"string"
},
"unblinded":{
"type":"string"
},
"roleSeq":{
"type":"number"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
}
},
"description":"List of global roles with ID and roleName, assigned to the user in this mode."
},
"studyRoles":{
"required":[
"studyRoleCreationType",
"studyRoleDesc",
"studyRoleDescLabel",
"studyRoleId",
"studyRoleName",
"studyRoleNameLabel",
"studyRoleStatus",
"studyRoleType",
"studyRoleTypeLabel"
],
"type":"object",
"properties":{
"studyId":{
"type":"string",
"format":"uuid"
},
"authorizedUserId":{
"type":"string",
"format":"uuid"
},
"modeId":{
"type":"string",
"format":"uuid"
},
"studyRoleId":{
"type":"string",
"format":"uuid"
},
"roleId":{
"type":"string",
"format":"uuid"
},
"studyRoleName":{
"type":"string"
},
"studyRoleDesc":{
"type":"string"
},
"studyRoleType":{
"type":"string"
},
"studyRoleStatus":{
"type":"string"
},
"studyRoleNameLabel":{
"type":"string"
},
"studyRoleDescLabel":{
"type":"string"
},
"studyRoleTypeLabel":{
"type":"string"
},
"studyRoleCreationType":{
"type":"string"
},
"effectiveStart":{
"type":"string",
"format":"date-time"
},
"effectiveEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"userId":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"studyRoleVersion":{
"type":"string"
},
"roles":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RoleDtoParams"
}
}
},
"description":"List of study-level roles assigned to this user in this mode."
},
"CodeListDto":{
"type":"object",
"properties":{
"codeName":{
"type":"string"
},
"codeType":{
"type":"string"
},
"comment":{
"type":"string"
},
"id":{
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"type":"number"
},
"operationType":{
"type":"string"
},
"optLock":{
"type":"string",
"format":"date-time"
},
"reason":{
"type":"string",
"writeOnly":true
},
"softwareVersionNumber":{
"type":"number"
},
"userId":{
"type":"string",
"format":"uuid"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValueDto"
}
}
}
},
"CodeValueDto":{
"type":"object",
"properties":{
"codeId":{
"type":"string",
"format":"uuid"
},
"codeLabel":{
"type":"string"
},
"codeValue":{
"type":"string"
},
"comment":{
"type":"string"
},
"id":{
"type":"string",
"format":"uuid"
},
"locale":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"operationType":{
"type":"string"
},
"optLock":{
"type":"string",
"format":"date-time"
},
"reason":{
"type":"string",
"writeOnly":true
},
"softwareVersionNumber":{
"type":"number"
},
"userId":{
"type":"string",
"format":"uuid"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"versionStart":{
"type":"string",
"format":"date-time"
}
}
},
"CodeListResponse":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"object"
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"Code":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string)",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"versionStart":{
"type":"string",
"description":"Version start timestamp.",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"description":"Version end timestamp.",
"format":"date-time"
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type.",
"example":"CREATED"
},
"objectVersionNumber":{
"type":"number",
"description":"Object version number.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number.",
"example":1
},
"optlock":{
"type":"string",
"description":"Optimistic lock timestamp.",
"format":"date-time"
},
"userId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the user.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"reason":{
"type":"string",
"description":"Reason for change.",
"example":"Updating codelist"
},
"comment":{
"type":"string",
"description":"Comment.",
"example":"Updated description"
},
"codeName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Codelist code name.",
"example":"AE_SEVERITY"
},
"codeType":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Codelist code type.",
"example":"SYSTEM"
},
"codeLevel":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Codelist code level.",
"example":"SYSTEM"
},
"parCodeName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Parent codelist code name.",
"example":"AE"
},
"description":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Codelist description.",
"example":"Severity of adverse event."
},
"tag":{
"maxLength":32767,
"minLength":1,
"type":"string",
"description":"Tag for the codelist.",
"example":"safety"
},
"codeGroupId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the codelist group.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"displayCodeName":{
"type":"string",
"description":"Display name for the codelist.",
"example":"AE Severity"
},
"canAddValues":{
"type":"boolean",
"description":"Whether values can be added.",
"example":true
},
"canHideValues":{
"type":"boolean",
"description":"Whether values can be hidden.",
"example":true
},
"customizable":{
"type":"boolean"
},
"tenantLevelOnly":{
"type":"boolean"
}
}
},
"CodeListTO":{
"type":"object",
"properties":{
"code":{
"$ref":"#/components/schemas/Code"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValue"
}
}
}
},
"CodeValue":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string)",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"versionStart":{
"type":"string",
"description":"Version start timestamp.",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"description":"Version end timestamp.",
"format":"date-time"
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type.",
"example":"CREATED"
},
"objectVersionNumber":{
"type":"number",
"description":"Object version number.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number.",
"example":1
},
"optlock":{
"type":"string",
"description":"Optimistic lock timestamp.",
"format":"date-time"
},
"userId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the user.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"reason":{
"type":"string",
"description":"Reason for change.",
"example":"Updating codelist values"
},
"comment":{
"type":"string",
"description":"Comment.",
"example":"Updated label"
},
"codeId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the parent codelist code.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"locale":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Locale code.",
"example":"en"
},
"codeValue":{
"maxLength":32767,
"minLength":1,
"type":"string",
"description":"Codelist value.",
"example":"MILD"
},
"codeLabel":{
"maxLength":32767,
"minLength":1,
"type":"string",
"description":"Codelist value label.",
"example":"Mild"
},
"code":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Codelist value code (legacy).",
"example":"MILD"
},
"sequence":{
"type":"number",
"description":"Display sequence.",
"example":1
},
"language":{
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Language code.",
"example":"en"
},
"codeGroupId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the codelist group.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"hidden":{
"type":"boolean",
"description":"Whether the value is hidden.",
"example":false
},
"customizationType":{
"type":"string",
"description":"Customization type.",
"example":"CUSTOM"
},
"loinc":{
"type":"string",
"description":"LOINC code.",
"example":"1234-5"
}
}
},
"BaseCodeListDto":{
"type":"object",
"properties":{
"code":{
"type":"object"
},
"values":{
"type":"array",
"items":{
"type":"object"
}
}
}
},
"CodeListRequestV1":{
"type":"object",
"properties":{
"code":{
"$ref":"#/components/schemas/CodeV1"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValueV1"
}
}
}
},
"CodeV1":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"optlock":{
"type":"string",
"format":"date-time"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeName":{
"type":"string"
},
"description":{
"type":"string"
},
"codeType":{
"type":"string"
},
"codeLevel":{
"type":"string"
},
"parCodeName":{
"type":"string"
}
}
},
"CodeValueV1":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeId":{
"type":"string",
"format":"uuid"
},
"codeValue":{
"type":"string"
},
"codeLabel":{
"type":"string"
},
"code":{
"type":"string"
},
"sequence":{
"type":"number"
},
"locale":{
"type":"string"
},
"optLock":{
"type":"string",
"format":"date-time"
}
}
},
"CodeListTagRequestV1":{
"type":"object",
"properties":{
"code":{
"$ref":"#/components/schemas/CodeV2"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValueV1"
}
}
}
},
"CodeV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"optlock":{
"type":"string",
"format":"date-time"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeName":{
"type":"string"
},
"description":{
"type":"string"
},
"codeType":{
"type":"string"
},
"codeLevel":{
"type":"string"
},
"parCodeName":{
"type":"string"
},
"tag":{
"type":"string"
}
}
},
"EntityTag":{
"type":"object",
"properties":{
"value":{
"type":"string"
},
"weak":{
"type":"boolean"
}
}
},
"Link":{
"type":"object",
"properties":{
"type":{
"type":"string"
},
"params":{
"type":"object",
"additionalProperties":{
"type":"string"
}
},
"uri":{
"type":"string",
"format":"uri"
},
"title":{
"type":"string"
},
"uriBuilder":{
"$ref":"#/components/schemas/UriBuilder"
},
"rel":{
"type":"string"
},
"rels":{
"type":"array",
"items":{
"type":"string"
}
}
}
},
"MediaType":{
"type":"object",
"properties":{
"type":{
"type":"string"
},
"subtype":{
"type":"string"
},
"parameters":{
"type":"object",
"additionalProperties":{
"type":"string"
}
},
"wildcardType":{
"type":"boolean"
},
"wildcardSubtype":{
"type":"boolean"
}
}
},
"MultivaluedMapStringObject":{
"type":"object",
"properties":{
"empty":{
"type":"boolean"
}
},
"additionalProperties":{
"type":"array",
"items":{
"type":"object"
}
}
},
"MultivaluedMapStringString":{
"type":"object",
"properties":{
"empty":{
"type":"boolean"
}
},
"additionalProperties":{
"type":"array",
"items":{
"type":"string"
}
}
},
"NewCookie":{
"type":"object",
"properties":{
"name":{
"type":"string"
},
"value":{
"type":"string"
},
"version":{
"type":"integer",
"format":"int32"
},
"path":{
"type":"string"
},
"domain":{
"type":"string"
},
"comment":{
"type":"string"
},
"maxAge":{
"type":"integer",
"format":"int32"
},
"expiry":{
"type":"string",
"format":"date-time"
},
"secure":{
"type":"boolean"
},
"httpOnly":{
"type":"boolean"
},
"sameSite":{
"type":"string",
"enum":[
"NONE",
"LAX",
"STRICT"
]
}
}
},
"Response":{
"type":"object",
"properties":{
"length":{
"type":"integer",
"format":"int32"
},
"location":{
"type":"string",
"format":"uri"
},
"language":{
"type":"object",
"properties":{
"language":{
"type":"string"
},
"displayName":{
"type":"string"
},
"country":{
"type":"string"
},
"variant":{
"type":"string"
},
"script":{
"type":"string"
},
"unicodeLocaleAttributes":{
"uniqueItems":true,
"type":"array",
"items":{
"type":"string"
}
},
"unicodeLocaleKeys":{
"uniqueItems":true,
"type":"array",
"items":{
"type":"string"
}
},
"displayLanguage":{
"type":"string"
},
"displayScript":{
"type":"string"
},
"displayCountry":{
"type":"string"
},
"displayVariant":{
"type":"string"
},
"extensionKeys":{
"uniqueItems":true,
"type":"array",
"items":{
"type":"string"
}
},
"iso3Language":{
"type":"string"
},
"iso3Country":{
"type":"string"
}
}
},
"date":{
"type":"string",
"format":"date-time"
},
"lastModified":{
"type":"string",
"format":"date-time"
},
"metadata":{
"type":"object",
"properties":{
"empty":{
"type":"boolean"
}
},
"additionalProperties":{
"type":"array",
"items":{
"type":"object"
}
}
},
"status":{
"type":"integer",
"format":"int32"
},
"entity":{
"type":"object"
},
"cookies":{
"type":"object",
"additionalProperties":{
"$ref":"#/components/schemas/NewCookie"
}
},
"links":{
"uniqueItems":true,
"type":"array",
"items":{
"$ref":"#/components/schemas/Link"
}
},
"statusInfo":{
"$ref":"#/components/schemas/StatusType"
},
"mediaType":{
"$ref":"#/components/schemas/MediaType"
},
"allowedMethods":{
"uniqueItems":true,
"type":"array",
"items":{
"type":"string"
}
},
"entityTag":{
"$ref":"#/components/schemas/EntityTag"
},
"stringHeaders":{
"type":"object",
"properties":{
"empty":{
"type":"boolean"
}
},
"additionalProperties":{
"type":"array",
"items":{
"type":"string"
}
}
},
"headers":{
"type":"object",
"properties":{
"empty":{
"type":"boolean"
}
},
"additionalProperties":{
"type":"array",
"items":{
"type":"object"
}
}
},
"closed":{
"type":"boolean"
}
}
},
"StatusType":{
"type":"object",
"properties":{
"family":{
"type":"string",
"enum":[
"INFORMATIONAL",
"SUCCESSFUL",
"REDIRECTION",
"CLIENT_ERROR",
"SERVER_ERROR",
"OTHER"
]
},
"statusCode":{
"type":"integer",
"format":"int32"
},
"reasonPhrase":{
"type":"string"
}
}
},
"UriBuilder":{
"type":"object"
},
"CodeListGroupDto":{
"title":"CodeListGroupDto",
"type":"object",
"properties":{
"codeGroupId":{
"type":"string",
"description":"Group GUID",
"format":"uuid"
},
"codeGroupName":{
"type":"string",
"description":"Name of the CodeList Group",
"example":"ABC Pharma"
}
},
"description":"Representation of CodeList Group"
},
"CodeListResponseCodeListGroupDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/CodeListGroupDto"
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"CodeListResponseListCodeListGroupDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeListGroupDto"
}
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"CodeListGroupRequest":{
"title":"CodeListGroupRequest",
"type":"object",
"properties":{
"codeGroupName":{
"type":"string",
"description":"Name of the CodeList Group",
"example":"ABC Pharma"
}
},
"description":"Representation of CodeList Group"
},
"CodeListTagV1":{
"type":"object",
"properties":{
"codeId":{
"type":"string"
},
"tagName":{
"type":"string"
}
}
},
"CodeValueV4":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeId":{
"type":"string",
"format":"uuid"
},
"codeValue":{
"type":"string"
},
"codeLabel":{
"type":"string"
},
"language":{
"type":"string"
},
"code":{
"type":"string"
},
"sequence":{
"type":"number"
},
"locale":{
"type":"string"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"codeGroupId":{
"type":"string",
"format":"uuid"
},
"hidden":{
"type":"boolean"
},
"customizationType":{
"type":"string"
},
"loinc":{
"type":"string"
},
"optLock":{
"type":"string",
"format":"date-time"
}
}
},
"CodeV3":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"optlock":{
"type":"string",
"format":"date-time"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeName":{
"type":"string"
},
"description":{
"type":"string"
},
"codeType":{
"type":"string"
},
"codeLevel":{
"type":"string"
},
"parCodeName":{
"type":"string"
},
"tag":{
"type":"string"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"codeGroupId":{
"type":"string",
"format":"uuid"
},
"displayCodeName":{
"type":"string"
},
"canAddValues":{
"type":"boolean"
},
"canHideValues":{
"type":"boolean"
},
"customizable":{
"type":"boolean"
},
"tenantLevelOnly":{
"type":"boolean"
}
}
},
"CodeGroup":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string)",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"versionStart":{
"type":"string",
"description":"Version start timestamp.",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"description":"Version end timestamp.",
"format":"date-time"
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type.",
"example":"CREATED"
},
"objectVersionNumber":{
"type":"number",
"description":"Object version number.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number.",
"example":1
},
"optlock":{
"type":"string",
"description":"Optimistic lock timestamp.",
"format":"date-time"
},
"userId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the user.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"reason":{
"type":"string",
"description":"Reason for change.",
"example":"Updating code groups"
},
"comment":{
"type":"string",
"description":"Comment.",
"example":"Renamed group"
},
"groupName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Codelist group name.",
"example":"Default Group"
}
}
},
"CodeListRequestV2":{
"type":"object",
"properties":{
"code":{
"$ref":"#/components/schemas/CodeV2"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValueV2"
}
}
}
},
"CodeValueV2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeId":{
"type":"string",
"format":"uuid"
},
"codeValue":{
"type":"string"
},
"codeLabel":{
"type":"string"
},
"language":{
"type":"string"
},
"code":{
"type":"string"
},
"sequence":{
"type":"number"
},
"locale":{
"type":"string"
},
"optLock":{
"type":"string",
"format":"date-time"
}
}
},
"CodeListRequestV3":{
"type":"object",
"properties":{
"code":{
"$ref":"#/components/schemas/CodeV3"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValueV3"
}
}
}
},
"CodeValueV3":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeId":{
"type":"string",
"format":"uuid"
},
"codeValue":{
"type":"string"
},
"codeLabel":{
"type":"string"
},
"language":{
"type":"string"
},
"code":{
"type":"string"
},
"sequence":{
"type":"number"
},
"locale":{
"type":"string"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"codeGroupId":{
"type":"string",
"format":"uuid"
},
"hidden":{
"type":"boolean"
},
"customizationType":{
"type":"string"
},
"optLock":{
"type":"string",
"format":"date-time"
}
}
},
"CodeListRequestV4":{
"type":"object",
"properties":{
"code":{
"$ref":"#/components/schemas/CodeV3"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValueV4"
}
}
}
},
"CodeListRequestV5":{
"type":"object",
"properties":{
"code":{
"$ref":"#/components/schemas/CodeV3"
},
"values":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CodeValueV5"
}
}
}
},
"CodeValueV5":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"format":"date-time"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number"
},
"softwareVersionNumber":{
"type":"number"
},
"userId":{
"type":"string",
"format":"uuid"
},
"reason":{
"type":"string"
},
"comment":{
"type":"string"
},
"codeId":{
"type":"string",
"format":"uuid"
},
"codeValue":{
"type":"string"
},
"codeLabel":{
"type":"string"
},
"language":{
"type":"string"
},
"code":{
"type":"string"
},
"sequence":{
"type":"number"
},
"locale":{
"type":"string"
},
"studyId":{
"type":"string",
"format":"uuid"
},
"codeGroupId":{
"type":"string",
"format":"uuid"
},
"hidden":{
"type":"boolean"
},
"customizationType":{
"type":"string"
},
"loinc":{
"type":"string"
},
"modeSiteMappings":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ModeSiteMappingTO"
}
},
"optLock":{
"type":"string",
"format":"date-time"
}
}
},
"ModeSiteMappingTO":{
"type":"object",
"properties":{
"mode":{
"type":"string"
},
"sites":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SiteTO"
}
}
}
},
"SiteTO":{
"required":[
"siteId"
],
"type":"object",
"properties":{
"siteId":{
"type":"string",
"format":"uuid"
},
"isAssociated":{
"type":"boolean"
}
}
},
"DataElementDto":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
}
},
"description":"Base data element details including identity, study and subject context, values and metadata"
},
"DcsResponse":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"object"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"ClearRequestDto":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Data correction"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Incorrect entry; clearing to re-enter"
},
"visits":{
"type":"array",
"description":"List of visit-level clear requests containing event, instance number and forms to clear",
"items":{
"$ref":"#/components/schemas/CoreClearVisitRequestDto"
}
}
},
"description":"Request to clear data elements for a subject at visit/form/item scope"
},
"CoreClearFormsRequestDto":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"50DB4EF4847849CCB24EFCCB71CDA436"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"example":1
}
},
"description":"Form-level clear request that identifies the form, repeats and optionally a specific item or section to clear"
},
"CoreClearVisitRequestDto":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"eventInstanceNumber":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":1
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"visitStartDateId":{
"type":"string",
"description":"Identifier of the Visit Start Date data element (UUID, 32-character uppercase hexadecimal string)",
"example":"DBCDEF1234567890ABCDEF1234567890"
},
"forms":{
"type":"array",
"description":"List of form-level clear requests to process in this visit",
"items":{
"$ref":"#/components/schemas/CoreClearFormsRequestDto"
}
}
},
"description":"Visit-level clear request that includes visit identifiers and the list of forms/items to clear"
},
"ClearFormsClearedDataDto10":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"Cleared data elements.",
"items":{
"$ref":"#/components/schemas/DataElementDto136"
}
},
"labs":{
"type":"array",
"description":"Cleared lab associations.",
"items":{
"$ref":"#/components/schemas/DCPropertyDto"
}
}
},
"description":"Cleared data section for clear form response."
},
"ClearFormsNotClearedDataDto10":{
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Item identifier that could not be cleared.",
"example":"itemId1"
},
"isItemLocked":{
"type":"boolean",
"description":"Indicates whether item is locked.",
"example":true
},
"hasChildFormOrVisitData":{
"type":"boolean",
"description":"Indicates whether item has child form/visit data.",
"example":true
},
"isItemClearBlockedBySameFormChild":{
"type":"boolean",
"description":"Indicates whether clear is blocked by same-form child data.",
"example":true
},
"isItemFrozen":{
"type":"boolean",
"description":"Indicates whether item is frozen.",
"example":true
},
"isItemUnfrozen":{
"type":"boolean",
"description":"Indicates whether item was unfrozen.",
"example":true
},
"isItemReadOnly":{
"type":"boolean",
"description":"Indicates whether item is read-only for user.",
"example":true
},
"isItemSafetyTrigger":{
"type":"boolean"
}
},
"description":"Represents an item that could not be cleared in clear form API."
},
"ClearFormsResponseDto10":{
"type":"object",
"properties":{
"clearedData":{
"$ref":"#/components/schemas/ClearFormsClearedDataDto10"
},
"notClearedData":{
"type":"array",
"description":"Data elements that could not be cleared.",
"items":{
"$ref":"#/components/schemas/ClearFormsNotClearedDataDto10"
}
},
"visits":{
"$ref":"#/components/schemas/Visits"
},
"formsStatus":{
"type":"array",
"description":"Form status summary after clear action.",
"items":{
"$ref":"#/components/schemas/FormsStatusResponseDto"
}
}
},
"description":"Response payload for clear form API."
},
"DCPropertyDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"labId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the lab normals record. Include for update requests; omit for new create.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"reason":{
"type":"string",
"description":"Reason",
"example":"Data cleared by monitor"
},
"comment":{
"type":"string",
"description":"Comment",
"example":"Cleared due to verified lab correction"
}
},
"description":"Laboratory property details associated with a data element."
},
"DataElementDto136":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the data element was captured in the source system",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock state of the data element. Values LOCKED, UNLOCKED, NEVER_LOCKED",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the data element lock state last changed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"NEVER_LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date lock state last changed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"documentId":{
"type":"string",
"description":"Unique identifier of the associated source document (hex UUID, 32-character uppercase), enabling traceability between the data element and its original supporting document or file.",
"example":"A1B2C3D4E5F64789ABCDEF0123456789"
},
"documentVersion":{
"type":"number",
"description":"Version of the source or supporting document linked to this data element.",
"example":1
}
},
"description":"Data element DTO version 136"
},
"FormsStatusInnerRepeatDto":{
"type":"object",
"properties":{
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"IN_PROGRESS"
}
},
"description":"Inner repeat status for a specific outer repeat."
},
"FormsStatusOuterRepeatDto":{
"type":"object",
"properties":{
"innerRepeats":{
"type":"array",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"items":{
"$ref":"#/components/schemas/FormsStatusInnerRepeatDto"
}
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"IN_PROGRESS"
}
},
"description":"Outer repeat status with inner repeat entries."
},
"FormsStatusResponseDto":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"IN_PROGRESS"
},
"outerRepeats":{
"type":"array",
"description":"Outer repeat entries for this form",
"items":{
"$ref":"#/components/schemas/FormsStatusOuterRepeatDto"
}
}
},
"description":"Form status with outer repeat hierarchy."
},
"Visits":{
"type":"object",
"properties":{
"visitsStatus":{
"$ref":"#/components/schemas/VisitsStatusRuleTargetsDto7"
},
"refreshVisit":{
"type":"boolean",
"description":"Indicates whether the visit needs to be refreshed after the operation.",
"example":false
}
},
"description":"Visit status targets and refresh indicator."
},
"VisitsStatusRuleTargetsDto7":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"targets":{
"type":"array",
"description":"List of rule targets affected by this operation",
"example":[
"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC"
],
"items":{
"type":"string",
"description":"List of rule targets affected by this operation",
"example":"[\"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC\"]"
}
},
"associatedStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
}
},
"description":"Visit status update response including visit action and inherited rule targets"
},
"ClearFormsFormRequestDto":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"50DB4EF4847849CCB24EFCCB71CDA436"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"example":1
}
},
"description":"Form-level payload for clear form API."
},
"ClearFormsRequestDto":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Change for encoding"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment"
},
"visits":{
"type":"array",
"description":"List of visit payloads for clear form operation.",
"items":{
"$ref":"#/components/schemas/ClearFormsVisitRequestDto"
}
}
},
"description":"Request payload for clearing form data."
},
"ClearFormsVisitRequestDto":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"eventInstanceNumber":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":1
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"forms":{
"type":"array",
"description":"List of forms to clear in this visit.",
"items":{
"$ref":"#/components/schemas/ClearFormsFormRequestDto"
}
}
},
"description":"Visit-level payload for clear form API."
},
"DataElementDto90":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
}
},
"description":"Intermediate data element version including version end timestamp, operation type, software version, item classification, and lineage identifiers"
},
"FormsAssociations":{
"required":[
"associatedStudyVersion",
"srcStudyVersion"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"2F3C8B1BFE784C7E86E0B29899B13E3D"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A13F9C2E7B1D4F0A92CE31A4B6D9E8F1"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"9B7A13D4C2F84E1AA6D2E3F9BC18A457"
},
"srcEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"5D3AA89CE2B04729A1F1C7E62D9F44B2"
},
"srcEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"srcFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"C41E8B2D73A54F0C9AFE22D6A1138B90"
},
"srcRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"srcStudyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
},
"associatedEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"5D3AA89CE2B04729A1F1C7E62D9F44B2"
},
"associatedEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"associatedFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"8AA41F6E5D9B4F1A94E3C7B22A6610EF"
},
"associatedRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"associatedStudyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
},
"srcItemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"E2C77AB91F58443DB89A1D99F2F44C33"
},
"srcFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"associatedFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"C6E0C7D5A1F3428C8B8B6A77C5E9D4AB"
},
"srcRepeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
},
"associatedRepeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
},
"validationStatus":{
"type":"string",
"description":"Validation status for the association",
"example":"SUCCESS"
},
"validationFailure":{
"type":"string",
"description":"Validation failure details, if any",
"example":"Target form not found"
}
},
"description":"Association between a source form and an associated form, including repeat and study version context"
},
"DataElementDto7":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"propertyVersionStart":{
"type":"string",
"description":"Study version start",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
}
},
"DataElementDetails":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BBCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
}
},
"description":"Data element locator containing subject, event, form and repeat context."
},
"MultipleDataElementsRequestDto":{
"type":"object",
"properties":{
"dataElementDetails":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDetails"
}
}
}
},
"DataElementDto110":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
}
}
},
"RepeatingDataElementDetails":{
"required":[
"formId",
"itemId"
],
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A3F27C5D9B1E4D55A8E0C4F19A2D7F31"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"7C1E5AB4D9F648E4A93B21EF0A67C9D2"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"3F9D2A7C6E1B4C35B8D0F1239A45E8CD"
}
},
"description":"Identifiers to locate a specific data element for which repeating instances may exist"
},
"RepeatingMultipleDataElementsRequestDto":{
"type":"object",
"properties":{
"dataElementDetails":{
"type":"array",
"description":"List of data element identifiers for which repeating instances should be fetched",
"items":{
"$ref":"#/components/schemas/RepeatingDataElementDetails"
}
}
},
"description":"Request payload containing a list of data element identifiers to fetch repeating instances"
},
"DataElementDto121":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"LOCK"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the data element was captured in the source system",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the data element. Acceptable Values are LOCKED, NOT_APPLICABLE",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the data element was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Data element details including lock status, lock timestamp, and operation type."
},
"FormLockDto10":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"sectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"lockedDateTime":{
"type":"string",
"description":"Date and time when the form was locked",
"format":"date-time",
"example":"2024-12-01T10:15:30Z"
},
"lockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value.Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
}
},
"description":"Lock details for a form instance"
},
"FormsAssociationsDto2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2024-12-01T10:15:30Z"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"srcEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"srcEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"srcFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"srcRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"srcStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"associatedEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"associatedEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"associatedFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"associatedRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"associatedStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"reason":{
"type":"string",
"description":"Reason",
"example":"Data association update"
},
"comment":{
"type":"string",
"description":"Comment",
"example":"Updated association details"
},
"srcItemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"srcFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"associatedFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"associatedRepeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int64",
"example":1
},
"srcRepeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int64",
"example":1
}
},
"description":"Associations between source and associated form sections including repeat numbers"
},
"VisitDataDto10":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDto121"
}
},
"formsAssociations":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
},
"forms":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormLockDto10"
}
},
"visit":{
"$ref":"#/components/schemas/VisitLockDto"
}
}
},
"VisitLockDto":{
"type":"object",
"properties":{
"lockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value.Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Date and time when the visit was locked.",
"format":"date-time",
"example":"2024-12-01T10:15:30Z"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Date and time when the visit start date was locked.",
"format":"date-time",
"example":"2024-12-01T10:15:30Z"
}
},
"description":"Lock details for a visit, including visit start date lock information"
},
"DataElementRequestDto":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto"
}
}
},
"Context2":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the study",
"example":"DEMO_STUDY"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":1
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
}
},
"description":"Extended context including repeat sequence and repeat form number."
},
"CoreDataElementV4":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Primary uuid identifier for the data element instance (HEX, upper case).",
"example":"C1234567C1234567C1234567C1234567"
},
"transactionStart":{
"type":"string",
"description":"Transaction start date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T12:00:00Z"
},
"transactionEnd":{
"type":"string",
"description":"Transaction end date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T13:00:00Z"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D9876543D9876543D9876543D9876543"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":2
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"example":"E5554444E5554444E5554444E5554444"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"example":"F4443333F4443333F4443333F4443333"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Code supplied by vendor.",
"example":"VENDOR42"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Measured value captured for this data element.",
"example":"42.0"
},
"measureUnit":{
"type":"string",
"description":"Unit of measurement for this value (if applicable).",
"example":"mg/dL"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this data entry/edit.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Any general comments for the data element instance.",
"example":"Measured after fasting"
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"propertyId":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) of data capture properties",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2024-01-01T00:00:00Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
}
},
"description":"Core data element payload (v4)."
},
"DataElementFormAssociationsReq":{
"type":"object",
"properties":{
"formsAssociations":{
"type":"array",
"description":"List of form association operations associated with the data elements.",
"items":{
"$ref":"#/components/schemas/FormAssociationsDataElmntsReqDto1"
}
},
"context":{
"$ref":"#/components/schemas/Context2"
},
"dataElements":{
"type":"array",
"description":"List of data elements to process for the given context.",
"items":{
"$ref":"#/components/schemas/CoreDataElementV4"
}
}
},
"description":"Request payload combining context, data elements, and form association operations."
},
"FormAssociationsDataElmntsReqDto1":{
"type":"object",
"properties":{
"associatedEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"associatedEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"associatedFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"associatedRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"example":1
},
"srcItemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
}
},
"description":"Association details for a source item to a target form/visit"
},
"DataElementDto80":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Data element properties including property identifier and version start timestamp"
},
"DataElementsFormAssociationsDto":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements returned.",
"items":{
"$ref":"#/components/schemas/DataElementDto80"
}
},
"formsAssociations":{
"type":"array",
"description":"List of form associations corresponding to data elements.",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto"
}
}
},
"description":"Response payload containing data elements and their form associations."
},
"FormsAssociationsDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2024-12-01T10:15:30Z"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"srcEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"srcEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"srcFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"srcRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"srcStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"associatedEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"associatedEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"associatedFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"associatedRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"associatedStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"reason":{
"type":"string",
"description":"Reason",
"example":"Data association update"
},
"comment":{
"type":"string",
"description":"Comment",
"example":"Updated association details"
},
"srcItemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"0123456789ABCDEF0123456789ABCDEF"
}
},
"description":"Associations between source and target forms within visits and study versions"
},
"DcsResponseDataElementsFormAssociationsDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/DataElementsFormAssociationsDto"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"Context3":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the study",
"example":"DEMO_STUDY"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":1
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"example":1
}
},
"description":"Extended context including inner and outer repeat indices."
},
"CoreDataElementV6":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Primary uuid identifier for the data element instance (HEX, upper case).",
"example":"C1234567C1234567C1234567C1234567"
},
"transactionStart":{
"type":"string",
"description":"Transaction start date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T12:00:00Z"
},
"transactionEnd":{
"type":"string",
"description":"Transaction end date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T13:00:00Z"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D9876543D9876543D9876543D9876543"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":2
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"example":"E5554444E5554444E5554444E5554444"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"example":"F4443333F4443333F4443333F4443333"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Code supplied by vendor.",
"example":"VENDOR42"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Measured value captured for this data element.",
"example":"42.0"
},
"measureUnit":{
"type":"string",
"description":"Unit of measurement for this value (if applicable).",
"example":"mg/dL"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this data entry/edit.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Any general comments for the data element instance.",
"example":"Measured after fasting"
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"propertyId":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) of data capture properties",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2024-01-01T00:00:00Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp from the data source when this element was generated.",
"format":"date-time",
"example":"2024-01-01T00:00:00Z"
}
},
"description":"Core data element payload (v6)."
},
"DataElementsRequestDto6":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context3"
},
"dataElements":{
"type":"array",
"description":"List of data elements to process for the given context.",
"items":{
"$ref":"#/components/schemas/CoreDataElementV6"
}
}
},
"description":"Request payload to create or update data elements with contextual information and the list of elements."
},
"Context":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the study",
"example":"DEMO_STUDY"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":1
}
},
"description":"Context information including study, subject, event, form, site and event instance."
},
"CoreDataElement":{
"type":"object",
"properties":{
"utcDateTimeValue":{
"type":"string",
"format":"date-time"
},
"monthValue":{
"type":"integer"
},
"dayValue":{
"type":"integer"
},
"yearValue":{
"type":"integer"
},
"hourValue":{
"type":"integer"
},
"minuteValue":{
"type":"integer"
},
"secondValue":{
"type":"integer"
},
"validationStatus":{
"type":"string"
},
"validationFailure":{
"type":"string"
},
"id":{
"type":"string",
"format":"uuid"
},
"transactionStart":{
"type":"string",
"format":"date-time"
},
"transactionEnd":{
"type":"string",
"format":"date-time"
},
"formSectionId":{
"type":"string"
},
"variableId":{
"type":"string"
},
"originatorId":{
"type":"string"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string"
},
"itemId":{
"type":"string"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string"
},
"measureUnit":{
"type":"string"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string"
},
"numValue":{
"type":"integer"
},
"floatValue":{
"type":"number"
}
}
},
"DataElementsRequestDto":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context"
},
"dataElements":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CoreDataElement"
}
}
}
},
"DataElementRepeatingFormsReq":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context"
},
"repeatingForms":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RepeatingFormsDataElementReqDto"
}
}
}
},
"RepeatingFormsDataElementReqDto":{
"type":"object",
"properties":{
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"dataElements":{
"type":"array",
"description":"List of core data elements for this form instance",
"items":{
"$ref":"#/components/schemas/CoreDataElementV4"
}
}
},
"description":"Request for repeating forms data element containing repeat sequence and associated data elements."
},
"FormAssociationsUpdateRespDto":{
"type":"object",
"properties":{
"formsAssociations":{
"type":"array",
"description":"List of form associations",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto"
}
}
},
"description":"Form associations update response"
},
"DcsResponseFormAssociationsUpdateRespDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/FormAssociationsUpdateRespDto"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"FormAssociationsUpdateDto":{
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Change for encoding"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Adding association for derived form copy"
},
"formsAssociations":{
"type":"array",
"description":"List of form association operations to apply to the source form instance",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto"
}
}
},
"description":"Request payload to update form associations for a source form instance"
},
"ChildInfoDto1":{
"type":"object",
"properties":{
"itemEligibleForClear":{
"type":"boolean",
"description":"Indicates if the item is eligible to be cleared",
"example":false
},
"childInFuture":{
"type":"boolean",
"description":"True if the child item belongs to a future visit instance",
"example":false
},
"childIsHidden":{
"type":"boolean",
"description":"True if the child item is hidden by rule or configuration",
"example":false
},
"childIsLocked":{
"type":"boolean",
"description":"True if the child item is locked",
"example":false
},
"childIsFrozen":{
"type":"boolean",
"description":"True if the child item is frozen",
"example":false
},
"childIsUnFrozen":{
"type":"boolean",
"description":"True if the child item is unfrozen",
"example":false
},
"childIsReadOnly":{
"type":"boolean",
"description":"True if the child item is read-only",
"example":false
},
"isGrandParent":{
"type":"boolean",
"description":"True if the item is a grandparent item in hierarchy",
"example":false
},
"formAssociated":{
"type":"boolean",
"description":"True if the item is associated with a form association",
"example":false
},
"childItems":{
"type":"array",
"description":"List of child items derived for the requested operation",
"items":{
"type":"object",
"description":"List of child items derived for the requested operation"
}
}
},
"description":"Child information flags and child items for a data element operation"
},
"DataElementDto12":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
}
}
},
"DataElementDto11":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
}
},
"description":"Data element details for visit-level retrieval extending DataElementDto90 without form status"
},
"RuleConsolidatedResponseDto10":{
"type":"object",
"properties":{
"statusRepeatinginstances":{
"type":"string"
},
"resultRepeatinginstances":{
"type":"array",
"items":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDto11"
}
}
},
"statusMultiple":{
"type":"string"
},
"resultMultiple":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDto11"
}
}
},
"description":"Consolidated DC response containing results for repeatinginstances and multiple data element fetches."
},
"DcsResponseRuleConsolidatedResponseDto10":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/RuleConsolidatedResponseDto10"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElementDetails30":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BBCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"repeatTwoSectionFormNumber":{
"type":"integer",
"description":"Repeat section form number, if applicable.",
"format":"int32",
"example":1
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"50DB4EF4847849CCB24EFCCB71CDA436"
},
"isPrevValue":{
"type":"boolean",
"description":"If true, indicates the request refers to previous value",
"example":false
}
},
"description":"Data element details (v3) including flag to indicate whether previous value is requested."
},
"RuleConsolidatedRequestDto10":{
"type":"object",
"properties":{
"repeatinginstances":{
"type":"array",
"description":"Input for repeatinginstances (equivalent to repeatinginstances endpoint).",
"items":{
"$ref":"#/components/schemas/RepeatingDataElementDetails"
}
},
"multiple":{
"type":"array",
"description":"Input for multiple (equivalent to dataelements/multiple endpoint).",
"items":{
"$ref":"#/components/schemas/DataElementDetails30"
}
}
},
"description":"Request payload for consolidated DC calls used by Rule Service."
},
"CoreDataElementV3":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Primary uuid identifier for the data element instance (HEX, upper case).",
"example":"C1234567C1234567C1234567C1234567"
},
"transactionStart":{
"type":"string",
"description":"Transaction start date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T12:00:00Z"
},
"transactionEnd":{
"type":"string",
"description":"Transaction end date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T13:00:00Z"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D9876543D9876543D9876543D9876543"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":2
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"example":"E5554444E5554444E5554444E5554444"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"example":"F4443333F4443333F4443333F4443333"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Code supplied by vendor.",
"example":"VENDOR42"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Measured value captured for this data element.",
"example":"42.0"
},
"measureUnit":{
"type":"string",
"description":"Unit of measurement for this value (if applicable).",
"example":"mg/dL"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this data entry/edit.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Any general comments for the data element instance.",
"example":"Measured after fasting"
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"example":"B1B8327AFAA6412287106192AB5984EF"
}
},
"description":"Core data element payload (v3)."
},
"DataElementsRequestDto3":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context2"
},
"dataElements":{
"type":"array",
"description":"List of data elements to process for the given context.",
"items":{
"$ref":"#/components/schemas/CoreDataElementV3"
}
}
},
"description":"Request payload to create or update data elements with contextual information and the list of elements."
},
"DataElementDto50":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
},
"description":"Data element extension adding dataFlag identifier inherited by higher versions"
},
"DataElementsRequestDto4":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context2"
},
"dataElements":{
"type":"array",
"description":"List of data elements to process for the given context.",
"items":{
"$ref":"#/components/schemas/CoreDataElementV4"
}
}
},
"description":"Request payload for data elements used in multi-section forms, carrying context and a list of elements."
},
"DataElementDto8":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"propertyVersionStart":{
"type":"string",
"description":"Study version start",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
}
}
},
"ESignUrlDto":{
"type":"object",
"properties":{
"url":{
"type":"string",
"description":"Electronic signature URL.",
"format":"uri",
"example":"https://esign.example.com/process/7AB12CD3E4F5413C9BF46C56A9ED9B7A"
}
},
"description":"Electronic signature URL for the requested subject and organization."
},
"EnrollmentSetting":{
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the enrollment setting.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"groupTitle":{
"type":"string",
"description":"Title of the group receiving this setting.",
"example":"Cohort A"
},
"subjectLimit":{
"type":"integer",
"description":"Maximum number of subjects allowed in this group.",
"format":"int32",
"example":100
},
"notificationLimit":{
"type":"integer",
"description":"Notification threshold for approaching subject limit.",
"format":"int32",
"example":80
},
"description":{
"type":"string",
"description":"Brief description of the enrollment setting.",
"example":"Phase 1 - First cohort group"
},
"enableSetting":{
"type":"boolean",
"description":"Indicates if the enrollment setting is enabled.",
"example":true
}
},
"description":"Represents the persisted enrollment setting for a study group."
},
"EnrollmentGroupDto":{
"type":"object",
"properties":{
"title":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Title or description for the group criteria.",
"example":"Male subjects age 18-65"
},
"groupId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) for the group this criteria belongs to.",
"example":"BEEF11223344556677889900AABBCCDD"
},
"visitId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"FORM1"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"criteriaType":{
"maxLength":16,
"minLength":0,
"type":"string",
"description":"Type of criteria applied Should match either numeric or choice.",
"example":"choice"
},
"startRange":{
"type":"number",
"description":"Lower bound for range-type group criteria.",
"format":"double",
"example":18
},
"endRange":{
"type":"number",
"description":"Upper bound for range-type group criteria.",
"format":"double",
"example":65
},
"choiceValue":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"List of choice value objects, if applicable for enumeration-type criteria.",
"example":"[{\"value\":\"1\",\"label\":\"Yes\"}]"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"objectVersionNumber":{
"type":"integer",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":1
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for this group criteria record.",
"example":"1234567890AABBCCDDEEFF1122334455"
}
},
"description":"DTO describing individual cohort/criteria group for enrollment settings."
},
"EnrollmentSettingDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) for this enrollment setting.",
"example":"AA11BB22CC33DD44EE55FF6677889900"
},
"groupTitle":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Title or label for the group.",
"example":"Test Group"
},
"enableSetting":{
"type":"boolean",
"description":"Whether this enrollment setting is enabled.",
"example":true
},
"subjectLimit":{
"minimum":0,
"type":"integer",
"description":"Maximum number of subjects permitted.",
"format":"int32",
"example":100
},
"notificationLimit":{
"maximum":100,
"minimum":0,
"type":"integer",
"description":"Notification threshold for subject count.",
"format":"int32",
"example":60
},
"description":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Description for this enrollment setting.",
"example":"This setting applies to test group."
},
"objectVersionNumber":{
"type":"integer",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":2
},
"count":{
"type":"integer",
"description":"Count associated with this setting",
"format":"int32",
"example":1
},
"settingType":{
"type":"string",
"description":"Type of setting. It can be Scr_limit , Rand_limit",
"example":"Rand_limit"
},
"groupCriteria":{
"type":"object",
"properties":{
"title":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Title or description for the group criteria.",
"example":"Male subjects age 18-65"
},
"groupId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) for the group this criteria belongs to.",
"example":"BEEF11223344556677889900AABBCCDD"
},
"visitId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"FORM1"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"criteriaType":{
"maxLength":16,
"minLength":0,
"type":"string",
"description":"Type of criteria applied Should match either numeric or choice.",
"example":"choice"
},
"startRange":{
"type":"number",
"description":"Lower bound for range-type group criteria.",
"format":"double",
"example":18
},
"endRange":{
"type":"number",
"description":"Upper bound for range-type group criteria.",
"format":"double",
"example":65
},
"choiceValue":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"List of choice value objects, if applicable for enumeration-type criteria.",
"example":"[{\"value\":\"1\",\"label\":\"Yes\"}]"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"objectVersionNumber":{
"type":"integer",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":1
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for this group criteria record.",
"example":"1234567890AABBCCDDEEFF1122334455"
}
},
"description":"DTO describing individual cohort/criteria group for enrollment settings."
}
},
"description":"DTO representing enrollment setting details, including associated group criteria."
},
"LabRequestDto":{
"required":[
"eventId",
"formId",
"siteId",
"studyVersion",
"subjectId"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A1B2C3D4E5F6471890ABCDEF12345678"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"799EF3745FC545589F186D2198F3C65E"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"899EF3745FC545589F186D2198F3C65E"
},
"labId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the lab normals record. Include for update requests; omit for new create.",
"example":"999EF3745FC545589F186D2198F3C65E"
}
}
},
"DataElementDto6":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"propertyId":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) of data capture properties",
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"Data element response with additional property linkage details"
},
"LabResponse":{
"type":"object",
"properties":{
"labnormalsStatus":{
"type":"array",
"description":"List of lab normals processing status codes resulting from validation and mapping",
"example":[
"SUCCESS"
],
"items":{
"type":"string",
"description":"List of lab normals processing status codes resulting from validation and mapping",
"example":"[\"SUCCESS\"]"
}
},
"items":{
"type":"array",
"description":"List of data elements generated or updated for the lab normals request",
"example":[
{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"versionStart":"2025-10-16T14:30:31.892Z",
"transactionStart":"2025-10-16T14:30:31.892Z",
"transactionEnd":"2025-10-16T14:35:00.000Z",
"validationStatus":"SUCCESS",
"validationFailure":null,
"studyId":"ABCDEF1234567890ABCDEF1234567890",
"studyName":"STUDY-ABC",
"studyVersion":"21",
"subjectId":"10F75668189F422F9A461A315D211111",
"eventId":"ADF5A7800A954FA5B831E7B6B9CA39A9",
"formId":"FFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFF",
"formSectionId":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA",
"repeatSequenceNumber":1,
"itemId":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF",
"siteId":"ABCDEF1234567890ABCDEF1234567890",
"variableId":"0123456789ABCDEF0123456789ABCDEF",
"originatorId":"FEDCBA9876543210FEDCBA9876543210",
"vendorCode":"VENDOR1",
"value":"13.5",
"measureUnit":"g/dL",
"normalizedValue":"A78AD8C31CD843CD8B847C06C0420FF5",
"normalizedUnitId":"A78AD8C31CD843CD8B847C06C0420FF5",
"numValue":13,
"floatValue":13.5,
"dateTimeValueUTC":"2025-10-16T14:30:31.892Z",
"monthValue":10,
"dayValue":16,
"yearValue":2025,
"hourValue":14,
"minuteValue":30,
"secondValue":31,
"reason":"Initial entry",
"comment":"Captured by device",
"objectVersionNumber":14,
"eventInstanceNum":1,
"targets":[
"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE5",
"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE7"
],
"dataFlag":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"propertyId":"40DB4EF4847849CCB24EFCCB71CDA436",
"propertyVersionStart":"2025-10-16T14:30:31.892Z"
}
],
"items":{
"$ref":"#/components/schemas/DataElementDto6"
}
}
},
"description":"Response containing lab normals processing status and created/updated data elements for v1"
},
"LabUpdateRequestDto":{
"required":[
"eventId",
"formId",
"reason",
"siteId",
"studyVersion",
"subjectId"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A1B2C3D4E5F6471890ABCDEF12345678"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"799EF3745FC545589F186D2198F3C65E"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"899EF3745FC545589F186D2198F3C65E"
},
"labId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the lab normals record. Include for update requests; omit for new create.",
"example":"999EF3745FC545589F186D2198F3C65E"
},
"reason":{
"type":"string",
"description":"Reason",
"example":"Correction due to re-measurement"
},
"comment":{
"type":"string",
"description":"Comment",
"example":"Updated based on lab report 2023-02-10"
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
}
}
},
"DataElementWithTargets":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElement"
},
"targets":{
"type":"array",
"description":"List of display or rule targets associated with this data element",
"example":[
"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE5",
"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE7"
],
"items":{
"type":"string",
"description":"List of display or rule targets associated with this data element",
"example":"[\"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE5\",\"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE7\"]"
}
},
"labs":{
"type":"array",
"description":"List of cleared laboratory property details related to the data element",
"items":{
"$ref":"#/components/schemas/DCPropertyDto"
}
}
},
"description":"Wrapper combining a DataElement with its display targets and related lab properties."
},
"LabResponseDTO":{
"type":"object",
"properties":{
"labnormalsStatus":{
"type":"array",
"description":"List of lab normals processing status codes resulting from validation and mapping.The value of status can be -DOB_MISSING, GENDER_MISSING, RACE_MISSING, DOB_NO_VALUE_CAPTURED, GENDER_NO_VALUE_CAPTURED, RACE_NO_VALUE_CAPTURED,DOB_INVALID_VALUE, MISSING_CODE_LABEL_FOR_UNIT, MISSING_CODE_LABEL_FOR_NORMAL_TEXT",
"example":[
"GENDER_MISSING"
],
"items":{
"type":"string",
"description":"List of lab normals processing status codes resulting from validation and mapping.The value of status can be -DOB_MISSING, GENDER_MISSING, RACE_MISSING, DOB_NO_VALUE_CAPTURED, GENDER_NO_VALUE_CAPTURED, RACE_NO_VALUE_CAPTURED,DOB_INVALID_VALUE, MISSING_CODE_LABEL_FOR_UNIT, MISSING_CODE_LABEL_FOR_NORMAL_TEXT",
"example":"[\"GENDER_MISSING\"]"
}
},
"items":{
"type":"array",
"description":"List of data elements along with targets and associated cleared lab properties",
"items":{
"$ref":"#/components/schemas/DataElementWithTargets"
}
}
},
"description":"Service-level response containing lab normals processing status and data elements with targets and lab properties."
},
"PropertyDto1":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the property record.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Record version start timestamp.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"propertyType":{
"type":"string",
"description":"Type/category of the property.",
"example":"CODING_PROPERTY"
},
"propertyKey":{
"type":"string",
"description":"Unique key name of the property.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"propertyValue":{
"type":"string",
"description":"Value configured for the property.",
"example":"UTC"
},
"propertyAttr":{
"type":"string",
"description":"Additional attribute or data type for the property.",
"example":"{}"
},
"propertyStatus":{
"type":"string",
"description":" Status of the property.",
"example":"1"
},
"reason":{
"type":"string",
"description":"Reason for the change in property value.",
"example":"Initial configuration"
},
"comment":{
"type":"string",
"description":"Additional comments for the property update.",
"example":"Configured during study setup"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-01T10:00:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":300
}
},
"description":"Property Dto having fields which specify the unique property Id "
},
"DcsResponsePropertyDto1":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/PropertyDto1"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"PropertyRquestDto":{
"required":[
"labId",
"reason"
],
"type":"object",
"properties":{
"labId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the lab normals record. Include for update requests; omit for new create.",
"example":"B1B2C3D4E5F6471890ABCDEF12345678"
},
"reason":{
"type":"string",
"description":"Reason",
"example":"Correction"
},
"comment":{
"type":"string",
"description":"Comment",
"example":"Updated after review"
}
}
},
"LabResponseDto2":{
"type":"object",
"properties":{
"labnormalsStatus":{
"type":"array",
"description":"List of lab normals processing status codes resulting from validation and mapping.The value of status can be -DOB_MISSING, GENDER_MISSING, RACE_MISSING, DOB_NO_VALUE_CAPTURED, GENDER_NO_VALUE_CAPTURED, RACE_NO_VALUE_CAPTURED,DOB_INVALID_VALUE, MISSING_CODE_LABEL_FOR_UNIT, MISSING_CODE_LABEL_FOR_NORMAL_TEXT.",
"example":[
"GENDER_MISSING"
],
"items":{
"type":"string",
"description":"List of lab normals processing status codes resulting from validation and mapping.The value of status can be -DOB_MISSING, GENDER_MISSING, RACE_MISSING, DOB_NO_VALUE_CAPTURED, GENDER_NO_VALUE_CAPTURED, RACE_NO_VALUE_CAPTURED,DOB_INVALID_VALUE, MISSING_CODE_LABEL_FOR_UNIT, MISSING_CODE_LABEL_FOR_NORMAL_TEXT.",
"example":"[\"GENDER_MISSING\"]"
}
},
"items":{
"type":"array",
"description":"List of data elements generated or updated for the lab normals request",
"example":[
{
"id":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"versionStart":"2025-10-16T14:30:31.892Z",
"transactionStart":"2025-10-16T14:30:31.892Z",
"transactionEnd":"2025-10-16T14:35:00.000Z",
"validationStatus":"SUCCESS",
"validationFailure":null,
"studyId":"ABCDEF1234567890ABCDEF1234567890",
"studyName":"STUDY-ABC",
"studyVersion":"1.0.0.3",
"subjectId":"10F75668189F422F9A461A315D211111",
"eventId":"ADF5A7800A954FA5B831E7B6B9CA39A9",
"formId":"C6E0C7D5A1F3428C8B8B6A77C5E9D4AA",
"formSectionId":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA",
"repeatSequenceNumber":1,
"itemId":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF",
"siteId":"ABCDEF1234567890ABCDEF1234567890",
"variableId":"0123456789ABCDEF0123456789ABCDEF",
"originatorId":"FEDCBA9876543210FEDCBA9876543210",
"vendorCode":"VENDOR1",
"value":"13.5",
"measureUnit":"g/dL",
"normalizedValue":"A78AD8C31CD843CD8B847C06C0420FF5",
"normalizedUnitId":"A78AD8C31CD843CD8B847C06C0420FF5",
"numValue":13,
"floatValue":13.5,
"dateTimeValueUTC":"2025-10-16T14:30:31.892Z",
"monthValue":10,
"dayValue":16,
"yearValue":2025,
"hourValue":14,
"minuteValue":30,
"secondValue":31,
"reason":"Initial entry",
"comment":"Captured by device",
"objectVersionNumber":14,
"eventInstanceNum":1,
"targets":[
"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE5",
"93CC828113AC439181071CB44D2C6FE5.93CC828113AC439181071CB44D2C6FE7"
],
"dataFlag":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"signedStatus":"SIGNED",
"verifiedStatus":"NOT_APPLICABLE",
"freezedStatus":"NOT_APPLICABLE",
"operationType":"MODIFIED",
"propertyId":"40DB4EF4847849CCB24EFCCB71CDA436",
"propertyVersionStart":"2025-10-16T14:30:31.892Z",
"versionEnd":"2025-10-16T15:30:31.892Z",
"softwareVersionNumber":14,
"itemType":"TEXT",
"itemD":"DETAIL",
"itemF":"FLAG",
"itemR":"REASON",
"parentId":"ABCDEF1234567890ABCDEF1234567890",
"rootId":"1234567890ABCDEF1234567890ABCDEF",
"repeatFormNumber":2,
"innerRepeat":1,
"outerRepeat":1
}
],
"items":{
"$ref":"#/components/schemas/DataElementDto12"
}
}
},
"description":"Response containing lab normals processing status and created/updated data elements"
},
"SafetyCasePutResponseDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the updated safety case.",
"example":"123E4567E89B12D3A456426655440000"
},
"externalSafetyCaseId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) External identifier for the safety case.",
"example":"345E4567E89B12D3A456426655440000"
},
"status":{
"type":"string",
"description":"Status of the safety case. Value as defined as CREATED, SUBMITTED, NOT_SUBMITTED, ALL, MODIFIED, SUBMIT_FAILED, CANCEL_FAILED, REJECTED, TRANSFER_FAILED, CANCELLED, ACCEPTED,DISMISSED .",
"example":"CREATED"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"reason":{
"type":"string",
"description":"Reason for the status update.",
"example":"Other"
},
"comment":{
"type":"string",
"description":"Additional comments regarding the update.",
"example":"No further action required"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-07-01T10:20:30Z"
},
"lastSubmittedDate":{
"type":"string",
"description":"Last submission date/time related to the safety case.",
"format":"date-time",
"example":"2023-07-10T15:30:00Z"
}
},
"description":"Response object for SafetyCase update, providing status, identifiers and update information for the safety case."
},
"SafetyCaseRequestDto":{
"type":"object",
"properties":{
"status":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Status of the safety case. Value as defined as CREATED, SUBMITTED, NOT_SUBMITTED, ALL, MODIFIED, SUBMIT_FAILED, CANCEL_FAILED, REJECTED, TRANSFER_FAILED, CANCELLED, ACCEPTED,DISMISSED .",
"example":"CREATED"
},
"reason":{
"type":"string",
"description":"Reason for the safety case status change.",
"example":"Missing information"
},
"comment":{
"type":"string",
"description":"Comment for the safety case.",
"example":"Follow up with site on AE form"
},
"externalSafetyCaseId":{
"type":"string",
"description":"External identifier for the safety case, if available.",
"example":"12345"
}
},
"description":"Object holds request data for Safety Case update including status, reason for status change, comment, and the external safety case identifier."
},
"DataElementDto30":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
}
},
"description":"Data element properties including event instance number extension"
},
"FreezeRequestDTO":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"reason":{
"type":"string",
"description":"Reason for the operation, if supplied. Accepted values are Change for encoding, Incorrect Subject, Investigator Correction, Transcription Error, Other.",
"example":"Other"
},
"comment":{
"type":"string",
"description":"Any extra comment for the action when Other is selected in reason.",
"example":"The data required is missing."
},
"freezeVisitStartDate":{
"type":"boolean",
"description":"Target freeze status for the Visit Start Date. Allowed values: true/false",
"example":true
},
"elements":{
"type":"array",
"description":"List of core sign/verify target elements.",
"items":{
"$ref":"#/components/schemas/CoreSignVerifyRequestDto"
}
}
},
"xml":{
"name":"signVerifyRequest"
}
},
"SubjectVisitVerifyHistoryRequest":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subject unique identifiers in UUID, 32-character uppercase hexadecimal string format to filter by",
"example":[
"5D5F9311C591424F852B99FD902E98A4",
"6D5F9311C591424F852B99FD902E98A4"
],
"items":{
"type":"string",
"description":"List of subject unique identifiers in UUID, 32-character uppercase hexadecimal string format to filter by",
"format":"uuid"
}
},
"startDate":{
"type":"string",
"description":"Start date in dd-MMM-yyyy format",
"format":"date-time"
},
"endDate":{
"type":"string",
"description":"End date in dd-MMM-yyyy format",
"format":"date-time"
}
},
"description":"Request to fetch visit verify history for specified subjects within a date range. Dates must be provided in dd-MMM-yyyy format (Example- 01-Jan-2023)."
},
"SignVerifyDto":{
"title":"SignVerifyDto v1",
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string"
},
"eventId":{
"type":"string"
},
"formId":{
"type":"string"
},
"signed":{
"type":"string"
},
"verify":{
"type":"string"
},
"repeatSequenceNumber":{
"type":"integer"
},
"itemId":{
"type":"string"
},
"eventInstanceNum":{
"type":"integer"
},
"studyVersion":{
"maxLength":64,
"minLength":1,
"type":"string"
}
},
"description":"sign or verify request"
},
"UnFreezeRequest":{
"type":"object",
"properties":{
"reasonForChange":{
"type":"string",
"description":"A short description explaining the reason for the unfreeze action.",
"example":"Data Corrected"
}
},
"description":"Superclass for unfreeze requests, contains the reason for unfreezing.",
"example":{
"reasonForChange":"Data Corrected"
},
"xml":{
"name":"unfreezeRequest"
}
},
"SignVerifyRequestDto2":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"reason":{
"type":"string",
"description":"Reason for the operation, if supplied. Accepted values are Change for encoding, Incorrect Subject, Investigator Correction, Transcription Error, Other.",
"example":"Other"
},
"comment":{
"type":"string",
"description":"Any extra comment for the action when Other is selected in reason.",
"example":"The data required is missing."
},
"elements":{
"type":"array",
"description":"List of core sign/verify target elements.",
"items":{
"$ref":"#/components/schemas/CoreSignVerifyRequestDto"
}
},
"verifyVisitStartDate":{
"type":"boolean",
"description":"Target verify status for the Visit Start Date. Allowed values: true/false",
"example":true
}
},
"xml":{
"name":"signVerifyRequest"
}
},
"SDVGroupDto":{
"required":[
"sdvGroupName"
],
"type":"object",
"properties":{
"sdvGroupName":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Human readable name of the SDV group.",
"example":"StrategyTestSite"
},
"sdvGroupId":{
"type":"string",
"description":"ID of the Source Data Verification (SDV) group. The format is UUID, 32-character uppercase hexadecimal string.",
"example":"EFC64B3862FD4C85BB8DBEAE2AE26B13"
},
"sdvGroupKeyValPairs":{
"type":"array",
"description":"Key-value attributes that define SDV strategy behavior",
"items":{
"$ref":"#/components/schemas/SDVGroupKeyValDto"
}
}
},
"description":"Source Data Verification (SDV) group configuration and its attribute key-value pairs",
"xml":{
"name":"signVerifyRequest"
}
},
"SDVGroupKeyValDto":{
"required":[
"attributeKey",
"attributeValue"
],
"type":"object",
"properties":{
"attributeKey":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Key for a configurable attribute associated with this SDV group. Values may be REMAINING_SUBJECTS_PERCENTAGE, REMAINING_SUBJECTS_SDV_TYPE, INITIAL_SUBJECTS_SDV_TYPE, INITIAL_SUBJECTS_COUNT.",
"example":"INITIAL_SUBJECTS_COUNT"
},
"attributeValue":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Value for a configurable attribute associated with this SDV group. The acceptable values are - All Questions, Critical Questions Only or it can be a number like 30.",
"example":"All Questions"
}
},
"description":"Key-value attribute for SDV group configuration"
},
"SDVGroupInfo":{
"required":[
"attributeKey",
"attributeValue",
"sdvGroupName"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"9FCBB303F8D24A3FB7DABCACF7600629"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"attributeKey":{
"type":"string",
"description":"Key for a configurable attribute associated with this SDV group. Values may be REMAINING_SUBJECTS_PERCENTAGE, REMAINING_SUBJECTS_SDV_TYPE, INITIAL_SUBJECTS_SDV_TYPE, INITIAL_SUBJECTS_COUNT.",
"example":"INITIAL_SUBJECTS_COUNT"
},
"attributeValue":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Value for a configurable attribute associated with this SDV group. The acceptable values are - All Questions, Critical Questions Only or it can be a number like 30.",
"example":"20"
},
"sdvGroupName":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Human readable name of the SDV group.",
"example":"StrategyTestSite"
},
"sdvGroupId":{
"type":"string",
"description":"ID of the Source Data Verification (SDV) group. The format is UUID, 32-character uppercase hexadecimal string.",
"example":"EFC64B3862FD4C85BB8DBEAE2AE26B13"
}
},
"description":"Represents Source Data Verification (SDV) group attribute entry with audit fields"
},
"SDVGroupRequest":{
"required":[
"sdvGroupOldName"
],
"type":"object",
"properties":{
"sdvGroupOldName":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Human readable name of the SDV group.",
"example":"TestSDV_GROUP1"
},
"sdvGroupNewName":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Human readable name of the SDV group.",
"example":"TestSDV_GROUP1Updated"
},
"sdvGroupKeyValPairs":{
"type":"array",
"description":"List of SDV group attribute key/value pairs to update",
"items":{
"$ref":"#/components/schemas/SDVGroupKeyValDto"
}
}
},
"description":"Request to update SDV group attributes or rename the SDV group"
},
"SubjectDto1":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Base subject details including identity, demographics, study and site context, and state transitions"
},
"SubjectRequest1":{
"type":"object",
"properties":{
"SubjectDto":{
"$ref":"#/components/schemas/SubjectDto1"
}
},
"description":"Contains details related to subject"
},
"SubjectDto5":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Subject details extended with study origin and subject number site organization identifier"
},
"EnrollSubjectRequest":{
"title":"EnrollSubjectRequest v1",
"required":[
"fromStudyId",
"toStudyOrgId"
],
"type":"object",
"properties":{
"fromStudyId":{
"type":"string",
"description":"Originating Study Id (UUID, 32-char uppercase hex).",
"example":"367D03FD5B6146C08F874CE4A6E101F6"
},
"toStudyOrgId":{
"type":"string",
"description":"Target Site/Org Id where subject will enroll (UUID, 32-char uppercase hex).",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"subjectNumber":{
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0010"
}
},
"description":"Enrollment Request for Rollover Studies; supplies all linkage context for subject enrollment or rollover."
},
"SubjectEventDto":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Base subject event details including event type and transfer identifier"
},
"SubjectNumberSelectionDTO":{
"type":"object",
"properties":{
"lastAssignedNumber":{
"type":"string",
"description":"Last assigned subject number",
"example":"SUBJ-1223"
},
"availableNumbers":{
"type":"array",
"description":"Available subject numbers",
"example":"SUBJ-1224",
"items":{
"type":"string",
"description":"Available subject numbers",
"example":"SUBJ-1224"
}
}
},
"description":"DTO for subject number selection, containing the last assigned number and a list of currently available subject numbers."
},
"DemographicStatusResponse":{
"type":"object",
"properties":{
"genderDataAvailable":{
"type":"boolean",
"description":"True if gender data is available for this subject.",
"example":true
},
"dobDataAvailable":{
"type":"boolean",
"description":"True if date of birth data is available for this subject.",
"example":false
},
"raceDataAvailable":{
"type":"boolean",
"description":"True if race data is available for this subject.",
"example":true
}
},
"description":"Response indicating whether demographic data (gender, date of birth, race) is available for a subject."
},
"SubjectOrgIdDto":{
"title":"SubjectOrgIdDto v1",
"type":"object",
"properties":{
"orgId":{
"type":"string",
"description":"Site/Organization unique identifier (UUID, 32-character uppercase hexadecimal string)",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"OrgId used to generate subject number"
},
"RandomizationStatus":{
"type":"object",
"properties":{
"randomizationLimitReached":{
"type":"boolean",
"description":"Flag indicating if the randomization limit has been reached",
"example":true
},
"randomizationRestricted":{
"type":"boolean",
"description":"Flag indicating if randomization is restricted",
"example":false
}
},
"description":"Status indicating whether randomization is restricted or the randomization limit has been reached."
},
"SubjectSDVSelectionRequest":{
"type":"object",
"properties":{
"sites":{
"type":"array",
"description":"List of participating Site identifiers (UUID, 32-character uppercase hexadecimal strings).",
"example":[
"AA11BB22CC33DD44EE55FF6677889900",
"1234567890ABCDEF1234567890ABCDEF"
],
"items":{
"type":"string",
"description":"List of participating Site identifiers (UUID, 32-character uppercase hexadecimal strings).",
"format":"uuid"
}
},
"startDate":{
"type":"string",
"description":"Start date for SDV selection in dd-MMM-yyyy pattern.",
"example":"01-JAN-2023"
},
"endDate":{
"type":"string",
"description":"End date for SDV selection in dd-MMM-yyyy pattern",
"example":"31-JAN-2023"
}
},
"description":"SDV subject selection request, providing list of site UUIDs and date range for SDV operation."
},
"SubjectSDVDto2":{
"required":[
"subjectNumber"
],
"type":"object",
"properties":{
"versionStart":{
"type":"string",
"description":"The timestamp when the versioned SDV record began.",
"format":"date-time",
"example":"2025-08-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The timestamp when the versioned SDV record ended.",
"format":"date-time",
"example":"2025-08-31T18:00:00Z"
},
"id":{
"type":"string",
"description":"Unique identifier for the SDV subject (UUID, 32-character uppercase hexadecimal string)",
"example":"22223333444455556666777788889999"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0204"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"FEDCBA1234567890FEDCBA1234567890"
},
"sdvSelectionStatus":{
"type":"string",
"description":"Source data verification selection status for the subject it can be NOT_SELECTED, INITIALCOUNT_SELECTED, POST_INITIALCOUNT_SELECTED.",
"example":"NOT_SELECTED"
}
},
"description":"Subject SDV details (version 2) with visit window timestamps."
},
"Address1":{
"type":"object",
"properties":{
"streetName":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Street name line.",
"example":"123 Main Street"
}
},
"description":"Street name component of a postal address."
},
"city":{
"$ref":"#/components/schemas/City1"
},
"stateProv":{
"$ref":"#/components/schemas/StateProv1"
},
"country":{
"$ref":"#/components/schemas/Country1"
},
"postalCode":{
"$ref":"#/components/schemas/PostalCode1"
},
"otherText":{
"$ref":"#/components/schemas/OtherText1"
}
},
"description":"Postal or location address for an ODM user or site, with support for street, city, state, country, and postal code."
},
"AdminData1":{
"type":"object",
"properties":{
"User":{
"type":"object",
"properties":{
"loginName":{
"$ref":"#/components/schemas/LoginName1"
},
"displayName":{
"$ref":"#/components/schemas/DisplayName1"
},
"fullName":{
"$ref":"#/components/schemas/FullName10"
},
"firstName":{
"$ref":"#/components/schemas/FirstName10"
},
"lastName":{
"$ref":"#/components/schemas/LastName10"
},
"organization":{
"$ref":"#/components/schemas/Organization10"
},
"address":{
"type":"object",
"properties":{
"streetName":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Street name line.",
"example":"123 Main Street"
}
},
"description":"Street name component of a postal address."
},
"city":{
"$ref":"#/components/schemas/City1"
},
"stateProv":{
"$ref":"#/components/schemas/StateProv1"
},
"country":{
"$ref":"#/components/schemas/Country1"
},
"postalCode":{
"$ref":"#/components/schemas/PostalCode1"
},
"otherText":{
"$ref":"#/components/schemas/OtherText1"
}
},
"description":"Postal or location address for an ODM user or site, with support for street, city, state, country, and postal code."
},
"email":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Email address.",
"example":"john.smith@email.com"
}
},
"description":"Email address record for an ODM user."
},
"picture":{
"$ref":"#/components/schemas/Picture1"
},
"pager":{
"$ref":"#/components/schemas/Pager1"
},
"fax":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Fax number.",
"example":"555-5678"
}
},
"description":"Fax number/contact for an ODM User."
},
"phone":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Phone number.",
"example":"555-9876"
}
},
"description":"Phone number/contact entry for ODM User."
},
"locationRef":{
"type":"object",
"properties":{
"LocationOID":{
"type":"string",
"description":"OID/ID for the associated location.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Reference to a study/site location for an ODM User."
},
"certificate":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Certificate/credential identifier.",
"example":"CERT123"
}
},
"description":"Digital certificate or identity for an ODM User."
},
"userType":{
"type":"string",
"description":"Enumeration of possible user types/roles for ODM User.",
"enum":[
"SPONSOR",
"INVESTIGATOR",
"LAB",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"User OID value ",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Represents a user in the ODM AdminData structure (site personnel, investigator, etc)."
},
"Location":{
"type":"object",
"properties":{
"metaDataVersionRef":{
"type":"object",
"properties":{
"studyOID":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
"metaDataVersionOID":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the metadata version.",
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF11"
},
"effectiveDate":{
"type":"string",
"description":"Effective date for this metadata version in YYYY-MM-DD format.",
"example":"2025-01-31"
},
"effectiveDateTime":{
"type":"string",
"description":"Effective date and time for this metadata version in ISO-8601 format.",
"example":"2025-01-31T10:15:30Z"
}
},
"description":"Reference to a specific study metadata version with effective date information."
},
"name":{
"type":"string",
"description":"Name of the location.",
"example":"Main Site"
},
"locationType":{
"type":"string",
"description":"Type of location.",
"example":"OTHER",
"enum":[
"SPONSOR",
"SITE",
"CRO",
"LAB",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"ID of the site or depot of the kit",
"example":"A8C41D8062A14FCC89EDA475C3E3AF12"
}
},
"description":"Represents a site or location entity within the ODM context."
},
"SignatureDef":{
"type":"object",
"properties":{
"group":{
"type":"string",
"description":"Signature group or category.",
"example":"INVESTIGATOR"
},
"type":{
"type":"string",
"description":"Signature type.",
"example":"DIGITAL"
},
"meaning":{
"$ref":"#/components/schemas/Meaning1"
},
"legalReason":{
"$ref":"#/components/schemas/LegalReason1"
},
"oid":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"Definition of a signature including meaning, legal reason, and identifiers."
},
"StudyOID":{
"type":"string",
"description":"Study OID to which this admin data refers.",
"example":"D5E16DD550CB4AD1B330E0D09B4B8F3F"
}
},
"description":"ODM AdminData section: definition of users, locations, digital signatures, and study OID metadata."
},
"Alias1":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"Annotation2":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"Annotations1":{
"type":"object",
"properties":{
"annotation":{
"type":"array",
"description":"List of Annotation entries associated to the ODM structure.",
"items":{
"$ref":"#/components/schemas/Annotation2"
}
}
},
"description":"Container for a list of ODM Annotation entries."
},
"ArchiveLayout1":{
"type":"object",
"properties":{
"pdfFileName":{
"type":"string",
"description":"Name of the PDF file",
"example":"layout.pdf"
},
"presentationOID":{
"type":"string",
"description":"Presentation object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"oid":{
"type":"string",
"description":"ArchiveLayout object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Archive layout metadata for a form."
},
"ArchiveLayoutRef1":{
"type":"object",
"properties":{
"archiveLayoutOID":{
"type":"string",
"description":"Archive Layout OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Archive layout reference"
},
"AssociatedFormList1":{
"type":"object",
"properties":{
"auditTrail":{
"type":"array",
"description":"List of audit trail entries",
"items":{
"$ref":"#/components/schemas/AuditTrail1"
}
},
"formOID":{
"type":"string",
"description":"Form Identifier",
"example":"5ca47933-ab3c-4018-86c2-c6b77d2c5104.1_8_0_29"
},
"formIndex":{
"type":"number",
"description":"Index of the form within the visit",
"example":1
},
"formName":{
"type":"string",
"description":"Human readable name of the form",
"example":"Medical History"
},
"visitOID":{
"type":"string",
"description":"Visit Identifier",
"example":"6ca47933-ab3c-4018-86c2-c6b77d2c5104.1_8_0_29"
},
"visitIndex":{
"type":"number",
"description":"Index of the visit within the schedule",
"example":1
},
"visitName":{
"type":"string",
"description":"Human readable name of the visit",
"example":"Visit 1"
},
"deleted":{
"type":"boolean",
"description":"Indicates whether the associated form is deleted",
"example":false
},
"instanceNumber":{
"type":"integer",
"description":"Instance number of the unscheduled visit",
"format":"int64",
"example":1
}
},
"description":"Associated form details including visit and audit metadata"
},
"Association11":{
"type":"object",
"properties":{
"content":{
"type":"array",
"description":"List of associated elements",
"example":[
],
"items":{
"type":"object",
"description":"List of associated elements",
"example":[
]
}
},
"studyOID":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2.0.0.39.222eabde-1b96-48f6-9d3b-6250880a2b09"
},
"metaDataVersionOID":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
}
},
"description":"Association between study and metadata version with embedded content"
},
"AuditRecord100":{
"type":"object",
"properties":{
"userRef":{
"$ref":"#/components/schemas/UserRef10"
},
"locationRef":{
"$ref":"#/components/schemas/LocationRef1"
},
"dateTimeStamp":{
"$ref":"#/components/schemas/DateTimeStamp1"
},
"reasonForChange":{
"$ref":"#/components/schemas/ReasonForChange1"
},
"sourceID":{
"$ref":"#/components/schemas/SourceID1"
},
"id":{
"type":"string",
"description":"Audit record identifier",
"format":"identifier",
"example":"AUD1"
}
},
"description":"Audit trail entry describing who performed a change, where it occurred, when it happened, and the justification."
},
"AuditRecords1":{
"type":"object",
"properties":{
"auditRecord":{
"type":"array",
"description":"List of audit records associated with the subject or form.",
"items":{
"$ref":"#/components/schemas/AuditRecord100"
}
}
},
"description":"Container for a list of ODM audit record entries."
},
"AuditTrail1":{
"type":"object",
"properties":{
"dateTimeStamp":{
"type":"string",
"description":"Date and time of the change in ISO-8601 format",
"example":"2025-01-01T12:34:56Z"
},
"user":{
"type":"string",
"description":"User who performed the action",
"example":"john.doe"
},
"deleted":{
"type":"boolean",
"description":"Indicates whether the record was deleted as part of this change",
"example":false
},
"note":{
"type":"string",
"description":"Optional note associated with the change",
"example":"Correction applied"
}
},
"description":"Audit trail entry with timestamp, user, deletion status and note"
},
"BasicDefinitions10":{
"type":"object",
"properties":{
"MeasurementUnit":{
"type":"object",
"properties":{
"Symbol":{
"$ref":"#/components/schemas/Symbol10"
},
"Alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"Name":{
"type":"string",
"description":"Formal name of this measurement unit.",
"example":"mg/dL"
},
"OID":{
"type":"string",
"description":"Unique OID for this measurement unit. UUID uppercase hex.",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"A measurement unit reference used in study forms, such as mg/dL."
}
},
"description":"Root-level definitions for basic units and reference types in the ODM Study."
},
"CanonicalizationMethodType1":{
"type":"object",
"properties":{
"content":{
"type":"object",
"description":"Arbitrary content for CanonicalizationMethod child nodes."
},
"algorithm":{
"type":"string",
"description":"Canonicalization algorithm URI.",
"example":"http://www.w3.org/TR/2001/REC-xml-c14n-20010315"
}
},
"description":"Canonicalization method definition per XML Digital Signature specification."
},
"Certificate":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Certificate/credential identifier.",
"example":"CERT123"
}
},
"description":"Digital certificate or identity for an ODM User."
},
"CheckValue1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value to check in a range validation",
"example":"10"
}
},
"description":"A value used within a range validation."
},
"City1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"City name.",
"example":"San Francisco"
}
},
"description":"City component of a postal address."
},
"ClinicalData1":{
"type":"object",
"properties":{
"subjectData":{
"type":"array",
"description":"List of subject-level clinical data records",
"items":{
"$ref":"#/components/schemas/SubjectData1"
}
},
"auditRecords":{
"type":"array",
"description":"List of audit records associated with clinical data",
"items":{
"$ref":"#/components/schemas/AuditRecords1"
}
},
"Signatures":{
"type":"array",
"description":"List of digital signatures applied to the clinical data",
"items":{
"$ref":"#/components/schemas/Signatures1"
}
},
"Annotations":{
"type":"array",
"description":"List of annotations attached to the clinical data",
"items":{
"$ref":"#/components/schemas/Annotations1"
}
},
"StudyOID":{
"type":"string",
"description":"Study OID for which this clinical data applies",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"MetaDataVersionOID":{
"type":"string",
"description":"Metadata version OID associated with the study design",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"ODM ClinicalData section containing study OID, metadata version OID, and lists of subject data, audit records, signatures, and annotations."
},
"CodeList1":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"externalCodeList":{
"$ref":"#/components/schemas/ExternalCodeList1"
},
"enumeratedItem":{
"type":"object",
"properties":{
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"rank":{
"type":"number",
"description":"Optional rank for ordering",
"example":1
},
"orderNumber":{
"type":"integer",
"description":"Order number within the code list",
"format":"int64",
"example":1
}
},
"description":"Enumerated item value with optional ordering and aliases."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Code list name",
"example":"GENDER"
},
"dataType":{
"type":"string",
"description":"Code list data type",
"enum":[
"INTEGER",
"FLOAT",
"TEXT",
"STRING"
]
},
"SASFormatName":{
"type":"string",
"description":"SAS format name for the code list",
"example":"BEST12."
},
"codeListItem":{
"type":"object",
"properties":{
"decode":{
"$ref":"#/components/schemas/Decode1"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"orderNumber":{
"type":"integer",
"description":"Order number of this item",
"format":"int64",
"example":1
}
},
"description":"Represents a single code list item with decode and metadata."
},
"oid":{
"type":"string",
"description":"CodeList object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Code list definition including items or external mappings."
},
"CodeListItem1":{
"type":"object",
"properties":{
"decode":{
"$ref":"#/components/schemas/Decode1"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"orderNumber":{
"type":"integer",
"description":"Order number of this item",
"format":"int64",
"example":1
}
},
"description":"Represents a single code list item with decode and metadata."
},
"CodeListRef1":{
"type":"object",
"properties":{
"codeListOID":{
"type":"string",
"description":"OID of the referenced code list",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to a CodeList by its OID."
},
"Comment2":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Comment",
"example":"User-entered comment"
},
"sponsorOrSite":{
"type":"string",
"description":"Comment origin (Sponsor or Site)",
"example":"Site"
}
},
"description":"Comment DTO"
},
"ConditionDef1":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Condition name",
"example":"AgeGreaterThan18"
},
"oid":{
"type":"string",
"description":"Condition object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Condition definition containing formal expressions and metadata."
},
"Country1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Country code or name.",
"example":"US"
}
},
"description":"Country component of a postal address."
},
"CryptoBindingManifest10":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Base64-encoded manifest payload.",
"example":"VGhpcyBpcyBhIG1hbmlmZXN0IHBheWxvYWQ="
}
},
"description":"Cryptographic binding manifest that ties the signature to the signed payload."
},
"DateTimeStamp1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Raw date/time value",
"example":"2025-10-29T14:54:09"
},
"formattedValue":{
"type":"string",
"description":"Human-readable formatted date/time value",
"example":"29-Oct-2025 20:24:09 India Time ( Asia/Kolkata )"
}
},
"description":"Date/time stamp value with formatted representation."
},
"Decode1":{
"type":"object",
"properties":{
"translatedText":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Text value for this locale/language.",
"example":"gender"
},
"lang":{
"type":"string",
"description":"Language code for this translation, e.g. 'en'.",
"example":"null"
}
},
"description":"A localizable or translated representation of a symbol, label, or similar text element."
}
},
"description":"Decoded text for a code list item with translations."
},
"Description10":{
"type":"object",
"properties":{
"translatedText":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Text value for this locale/language.",
"example":"gender"
},
"lang":{
"type":"string",
"description":"Language code for this translation, e.g. 'en'.",
"example":"null"
}
},
"description":"A localizable or translated representation of a symbol, label, or similar text element."
}
},
"description":"Description DTO having information on the translated text"
},
"DigestMethodType1":{
"type":"object",
"properties":{
"content":{
"type":"object",
"description":"Optional content/parameters for the DigestMethod."
},
"algorithm":{
"type":"string",
"description":"Digest algorithm URI.",
"example":"http://www.w3.org/2001/04/xmlenc#sha256"
}
},
"description":"Digest method definition and optional parameters for computing the message digest in XML Digital Signatures."
},
"DisplayName1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value for the display name of the user.",
"example":"Dr. J. Smith"
}
},
"description":"Human-readable display name for the ODM User."
},
"Email1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Email address.",
"example":"john.smith@email.com"
}
},
"description":"Email address record for an ODM user."
},
"EnumeratedItem1":{
"type":"object",
"properties":{
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"rank":{
"type":"number",
"description":"Optional rank for ordering",
"example":1
},
"orderNumber":{
"type":"integer",
"description":"Order number within the code list",
"format":"int64",
"example":1
}
},
"description":"Enumerated item value with optional ordering and aliases."
},
"ErrorMessage1":{
"type":"object",
"properties":{
"translatedText":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Text value for this locale/language.",
"example":"gender"
},
"lang":{
"type":"string",
"description":"Language code for this translation, e.g. 'en'.",
"example":"null"
}
},
"description":"A localizable or translated representation of a symbol, label, or similar text element."
}
},
"description":"Error message details for validation failures."
},
"ExternalCodeList1":{
"type":"object",
"properties":{
"href":{
"type":"string",
"description":"Hyperlink reference to the external code list",
"example":"https://example.com/codelist/CL001"
},
"ref":{
"type":"string",
"description":"Reference identifier within the external system",
"example":"CL001"
},
"dictionary":{
"type":"string",
"description":"External dictionary name",
"example":"MedDRA"
},
"version":{
"type":"string",
"description":"External dictionary version",
"example":"24.0"
}
},
"description":"Reference to an external dictionary-based code list."
},
"ExternalQuestion1":{
"type":"object",
"properties":{
"code":{
"type":"string",
"description":"External question code",
"example":"QCODE123"
},
"dictionary":{
"type":"string",
"description":"Source dictionary name",
"example":"MedDRA"
},
"version":{
"type":"string",
"description":"Dictionary version",
"example":"24.0"
}
},
"description":"External question reference details."
},
"Fax1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Fax number.",
"example":"555-5678"
}
},
"description":"Fax number/contact for an ODM User."
},
"FirstName10":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Given name of the user.",
"example":"John"
}
},
"description":"User's first name."
},
"Flag1":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"FlagType1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Flag display value",
"example":"Y"
},
"codeListOID":{
"type":"string",
"description":"CodeList OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Flag type",
"example":{
"flagOID":"QUERY"
}
},
"FlagValue1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Flag value",
"example":"Y"
},
"codeListOID":{
"type":"string",
"description":"CodeList OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Flag value",
"example":{
"value":"Review"
}
},
"FormData10":{
"type":"object",
"properties":{
"AuditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"signature":{
"$ref":"#/components/schemas/Signature1"
},
"archiveLayoutRef":{
"$ref":"#/components/schemas/ArchiveLayoutRef1"
},
"Annotation":{
"type":"array",
"description":"Annotations (queries, notes, flags) for this form.",
"items":{
"$ref":"#/components/schemas/Annotation2"
}
},
"ItemGroupData":{
"type":"array",
"description":"Groups of item data contained in this form.",
"items":{
"$ref":"#/components/schemas/ItemGroupData1"
}
},
"FormOID":{
"type":"string",
"description":"Identifier (OID) of the form definition.",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"FormRepeatKey":{
"type":"string",
"description":"Repeat key when the same form occurs multiple times within an event.",
"example":"1"
},
"TransactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"Update"
},
"Status":{
"type":"string",
"description":"High-level status of the form (e.g., In Progress, Completed).",
"example":"Completed"
},
"TitleAddendum":{
"type":"string",
"description":"Additional title information for display.",
"example":"Follow-up Visit"
},
"FormStatus":{
"type":"string",
"description":"System-specific form status.",
"example":"LOCKED"
},
"NotDoneValue":{
"type":"string",
"description":"Reason/value indicating form was not performed.",
"example":"SUBJECT_UNAVAILABLE"
},
"Signatures":{
"$ref":"#/components/schemas/Signatures1"
}
},
"description":"Data captured for a single form within a study event, including items, annotations, signatures, and status."
},
"FormDef1":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemGroupRef":{
"type":"array",
"description":"Item group references for this form",
"items":{
"$ref":"#/components/schemas/ItemGroupRef1"
}
},
"archiveLayout":{
"type":"array",
"description":"Archive layouts defined for this form",
"items":{
"$ref":"#/components/schemas/ArchiveLayout1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the form",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"Form name",
"example":"Demographics"
},
"repeating":{
"type":"string",
"description":"Whether the form is repeating",
"enum":[
"Yes",
"No"
]
},
"hasIPR":{
"type":"boolean",
"description":"Indicates IPR exists for the form",
"example":true
},
"note":{
"type":"string",
"description":"Additional note for the form",
"example":"Requires supervisor review"
},
"revisionDate":{
"type":"string",
"description":"Form revision date",
"example":"2023-01-01"
},
"oid":{
"type":"string",
"description":"Form object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"id":{
"type":"string",
"description":"Form identifier",
"example":"9B9B96B684BA4822B98BFA612A070251"
}
},
"description":"Form definition containing item group references, archive layouts and metadata."
},
"FormHeader1":{
"type":"object",
"properties":{
"itemset":{
"type":"string",
"description":"Indicates whether this header represents an itemset.",
"example":"false"
},
"itemsetHeader":{
"type":"string",
"description":"Optional label or identifier for the itemset header.",
"example":"Vital Signs Panel"
},
"name":{
"type":"string",
"description":"Human-readable form name.",
"example":"Vital Signs"
},
"oid":{
"type":"string",
"description":"Object Identifier for the form (matches the form definition OID).",
"format":"oid",
"example":"FORM.VITALS"
}
},
"description":"Header metadata for a form instance, including basic identity and display information."
},
"FormRef":{
"type":"object",
"properties":{
"formOID":{
"type":"string",
"description":"OID of the referenced form",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of this form in the event",
"format":"int32",
"example":1
},
"mandatory":{
"type":"string",
"description":"Is this form mandatory in the event?",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception",
"example":"43caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"FormRef metadata"
},
"FormalExpression1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"FullName10":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Full name for the user.",
"example":"John Smith"
}
},
"description":"User's full name as a single value."
},
"GlobalVariables10":{
"type":"object",
"properties":{
"StudyName":{
"$ref":"#/components/schemas/StudyName10"
},
"StudyDescription":{
"$ref":"#/components/schemas/StudyDescription10"
},
"ProtocolName":{
"$ref":"#/components/schemas/ProtocolName10"
}
},
"description":"ODM GlobalVariables for a Study, providing human-readable study description and identifiers."
},
"History1":{
"type":"object",
"properties":{
"action":{
"type":"string",
"description":"Action taken on the entity.",
"example":"Verification"
},
"details":{
"type":"array",
"description":"Additional details about the action.",
"example":[
"Verified by Data Manager",
"No discrepancies found"
],
"items":{
"type":"string",
"description":"Additional details about the action.",
"example":"[\"Verified by Data Manager\",\"No discrepancies found\"]"
}
},
"actionDate":{
"type":"string",
"description":"Timestamp when the action occurred (ISO 8601).",
"format":"date-time",
"example":"2025-11-01T14:00:00Z"
}
},
"description":"Historical record describing an action performed on an ODM entity, with optional details and timestamp."
},
"ImputationMethod10":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Imputation method value",
"example":"MeanImputation"
},
"oid":{
"type":"string",
"description":"Imputation method object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Imputation method definition with value and identifier."
},
"Include10":{
"type":"object",
"properties":{
"StudyOID":{
"type":"string",
"description":"OID of the referenced study",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
},
"MetaDataVersionOID":{
"type":"string",
"description":"OID of the referenced MetaDataVersion",
"example":"77ad209a-99bc-4b84-901a-2dcd173dcda7.2_0_0_39"
}
},
"description":"Includes the metadata about the study version"
},
"InvestigatorRef1":{
"type":"object",
"properties":{
"userOID":{
"type":"string",
"description":"Identifier (OID) of the investigator user within the study.",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to an investigator user participating in the study."
},
"Item1":{
"type":"object",
"properties":{
"itemset":{
"type":"boolean",
"description":"Indicates whether this item represents an itemset (grid or repeating values).",
"example":false
},
"itemsetRows":{
"type":"string",
"description":"Row identifiers or count for the itemset when itemset is true.",
"example":"1"
},
"value":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"SAMPLE_VALUE"
},
"oid":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"3F2504E04F8911D39A0C0305E82C3301"
}
},
"description":"ODM Item instance with value and identifiers"
},
"ItemData1":{
"type":"object",
"properties":{
"AuditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"Signature":{
"$ref":"#/components/schemas/Signature1"
},
"MeasurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"Annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"ItemOID":{
"type":"string",
"description":"OID of the item",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"TransactionType":{
"type":"string",
"description":"Transaction type- INSERT, UPDATE, REMOVE, UPSERT or CONTEXT",
"example":"UPDATE",
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
},
"ParentItemOID":{
"type":"string",
"description":"OID of parent item",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"NotDone":{
"type":"string",
"description":"Whether item is not done (0 or 1)",
"example":"0"
},
"SelectedCodeListItemsType":{
"type":"string",
"description":"Selected code list items type",
"example":"CODE_A"
},
"Value":{
"type":"string",
"description":"Value for this item",
"example":"130"
},
"DocumentId":{
"type":"string",
"description":"Document ID reference",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"DocumentVersion":{
"type":"number",
"description":"Document version",
"example":1
}
},
"description":"Data captured for a Item "
},
"ItemDef1":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"question":{
"$ref":"#/components/schemas/Question1"
},
"externalQuestion":{
"$ref":"#/components/schemas/ExternalQuestion1"
},
"measurementUnitRef":{
"type":"object",
"properties":{
"MeasurementUnitOID":{
"type":"string",
"description":"OID of the referenced measurement unit",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Data captured for a Measurement Unit "
},
"rangeCheck":{
"type":"object",
"properties":{
"checkValue":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value to check in a range validation",
"example":"10"
}
},
"description":"A value used within a range validation."
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"measurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"errorMessage":{
"$ref":"#/components/schemas/ErrorMessage1"
},
"comparator":{
"type":"string",
"description":"Comparator operation",
"enum":[
"LT",
"LE",
"GT",
"GE",
"EQ",
"NE",
"IN",
"NOTIN"
]
},
"softHard":{
"type":"string",
"description":"Indicates hard or soft validation",
"enum":[
"SOFT",
"HARD"
]
}
},
"description":"Range check configuration for item validation."
},
"codeListRef":{
"$ref":"#/components/schemas/CodeListRef1"
},
"role":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value or name of the role",
"example":"DataEntry"
}
},
"description":"Represents the role associated with an item or definition."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"Name":{
"type":"string",
"description":"Item name",
"example":"DROPDOWN_03"
},
"DataType":{
"type":"string",
"description":"Data type (e.g., STRING, INT)",
"example":"string",
"enum":[
"integer",
"float",
"date",
"datetime",
"time",
"text",
"string",
"double",
"URI",
"boolean",
"hexBinary",
"base64Binary",
"hexFloat",
"base64Float",
"partialDate",
"partialTime",
"partialDatetime",
"durationDatetime",
"intervalDatetime",
"incompleteDatetime",
"incompleteDate",
"incompleteTime"
]
},
"Length":{
"type":"integer",
"description":"Length of string/numeric",
"format":"int32",
"example":255
},
"SignificantDigits":{
"type":"integer",
"description":"Number of significant digits",
"format":"int32",
"example":2
},
"Origin":{
"type":"string",
"description":"Item's origin data",
"example":"derived"
},
"Comment":{
"type":"string",
"description":"Free-text comment",
"example":"This is a calculated item."
},
"CaptionText":{
"type":"string",
"description":"UI caption text",
"example":"Please enter your name"
},
"ControlType":{
"type":"string",
"description":"UI control type",
"example":"TEXTBOX",
"enum":[
"pulldown",
"text",
"group",
"radiogroup",
"checkbox",
"calendar",
"element",
"calculated",
"instructionaltext",
"file"
]
},
"ControlLayout":{
"type":"string",
"description":"UI control layout style.Allowed values are INF_NOTDEFINED,INF_HORIZONTAL,INF_VERTICAL,INF_NOWRAP,INF_TWOCOLUMN,INF_THREECOLUMN",
"example":"INF_NOTDEFINED",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5"
]
},
"CaptionAlignment":{
"type":"string",
"description":"Caption alignment. Allowed Values are INF_NOTDEFINED ,INF_LEFT ,INF_CENTER ,INF_RIGHT ,INF_TOP ,INF_MIDDLE ,INF_BOTTOM",
"example":"INF_TOP",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5",
"6"
]
},
"InitialRowCount":{
"type":"string",
"description":"Initial number of rows",
"example":"1"
},
"DisplayMask":{
"type":"string",
"description":"Display mask for input",
"example":"999-99-9999"
},
"StartYear":{
"type":"string",
"description":"Start year for date input",
"example":"2000"
},
"EndYear":{
"type":"string",
"description":"End year for date input",
"example":"2025"
},
"UnknownMask":{
"type":"string",
"description":"Unknown input mask",
"example":"UNK"
},
"Calculated":{
"type":"string",
"description":"Is this item calculated?",
"example":"1"
},
"SelectionValue":{
"type":"string",
"description":"Selection value for this item",
"example":"Y"
},
"itemRef":{
"type":"object",
"properties":{
"itemOID":{
"type":"string",
"description":"OID of referenced item",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"keySequence":{
"type":"integer",
"description":"Key sequence for composite key",
"format":"int64",
"example":1
},
"methodOID":{
"type":"string",
"description":"Method OID for derivation",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"imputationMethodOID":{
"type":"string",
"description":"Imputation method OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"role":{
"type":"string",
"description":"Role of the referenced item",
"example":"DataEntry"
},
"roleCodeListOID":{
"type":"string",
"description":"OID for role code list",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of the item",
"format":"int64",
"example":2
},
"mandatory":{
"type":"string",
"description":"Is this item mandatory?",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception condition",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to an Item within an ItemGroup."
},
"IsDynamic":{
"type":"integer",
"description":"Is this item dynamic?",
"format":"int32",
"example":0
},
"IsSmartItem":{
"type":"integer",
"description":"Is this a smart item?",
"format":"int32",
"example":1
},
"SASFieldName":{
"type":"string",
"description":"Field name in SAS export",
"example":"HEIGHT_SAS"
},
"SDSVarName":{
"type":"string",
"description":"Field name in SDS export",
"example":"HEIGHT_SDS"
},
"OID":{
"type":"string",
"description":"Unique OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Item definition including question, code list, range checks and metadata."
},
"ItemGroupData1":{
"type":"object",
"properties":{
"auditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"signature":{
"$ref":"#/components/schemas/Signature1"
},
"annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"items":{
"type":"object",
"properties":{
"AuditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"Signature":{
"$ref":"#/components/schemas/Signature1"
},
"MeasurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"Annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"ItemOID":{
"type":"string",
"description":"OID of the item",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"TransactionType":{
"type":"string",
"description":"Transaction type- INSERT, UPDATE, REMOVE, UPSERT or CONTEXT",
"example":"UPDATE",
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
},
"ParentItemOID":{
"type":"string",
"description":"OID of parent item",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"NotDone":{
"type":"string",
"description":"Whether item is not done (0 or 1)",
"example":"0"
},
"SelectedCodeListItemsType":{
"type":"string",
"description":"Selected code list items type",
"example":"CODE_A"
},
"Value":{
"type":"string",
"description":"Value for this item",
"example":"130"
},
"DocumentId":{
"type":"string",
"description":"Document ID reference",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"DocumentVersion":{
"type":"number",
"description":"Document version",
"example":1
}
},
"description":"Data captured for a Item "
},
"itemGroupOID":{
"type":"string",
"description":"OID for this item group",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"itemGroupRepeatKey":{
"type":"string",
"description":"Repeat key for this group",
"example":"RPT1"
},
"transactionType":{
"type":"string",
"description":"Transaction type for the group",
"example":"INSERT",
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
}
},
"description":"Data captured for a Item Group"
},
"ItemGroupDef1":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemRef":{
"type":"array",
"description":"References to Items within this ItemGroup",
"items":{
"$ref":"#/components/schemas/ItemRef1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the ItemGroup",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"ItemGroup name",
"example":"Demographics Group"
},
"repeating":{
"type":"string",
"description":"Whether the ItemGroup is repeating",
"enum":[
"Yes",
"No"
]
},
"isReferenceData":{
"type":"string",
"description":"Indicates whether the ItemGroup holds reference data",
"enum":[
"Yes",
"No"
]
},
"domain":{
"type":"string",
"description":"Domain name for the ItemGroup",
"example":"DM"
},
"origin":{
"type":"string",
"description":"Origin of the ItemGroup data",
"example":"Collected"
},
"role":{
"type":"string",
"description":"Role of the ItemGroup",
"example":"CRF"
},
"purpose":{
"type":"string",
"description":"Purpose of the ItemGroup",
"example":"Analysis"
},
"comment":{
"type":"string",
"description":"Additional comments for the ItemGroup",
"example":"No special handling"
},
"SASDatasetName":{
"type":"string",
"description":"SAS dataset name mapped for the ItemGroup",
"example":"DM"
},
"oid":{
"type":"string",
"description":"ItemGroup object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"ItemGroup definition containing item references and metadata."
},
"ItemGroupRef1":{
"type":"object",
"properties":{
"orderNumber":{
"type":"integer",
"description":"Order number within the form",
"format":"int64",
"example":1
},
"mandatory":{
"type":"string",
"description":"Whether collection of the item group is mandatory",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"Condition OID that allows exception to collection",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"itemGroupOID":{
"type":"string",
"description":"ItemGroup object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to an ItemGroup within a form."
},
"ItemRef1":{
"type":"object",
"properties":{
"itemOID":{
"type":"string",
"description":"OID of referenced item",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"keySequence":{
"type":"integer",
"description":"Key sequence for composite key",
"format":"int64",
"example":1
},
"methodOID":{
"type":"string",
"description":"Method OID for derivation",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"imputationMethodOID":{
"type":"string",
"description":"Imputation method OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"role":{
"type":"string",
"description":"Role of the referenced item",
"example":"DataEntry"
},
"roleCodeListOID":{
"type":"string",
"description":"OID for role code list",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of the item",
"format":"int64",
"example":2
},
"mandatory":{
"type":"string",
"description":"Is this item mandatory?",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception condition",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to an Item within an ItemGroup."
},
"KeyInfoType1":{
"type":"object",
"properties":{
"content":{
"type":"object",
"description":"Key information content (e.g., X509Data, KeyName)."
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"Key information content (e.g., X509Data, KeyName) and optional identifier."
},
"LastName10":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Surname of the user.",
"example":"Smith"
}
},
"description":"User's last/family/surname."
},
"LegalReason1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Legal reason value.",
"example":"CONSENT_OBTAINED"
}
},
"description":"Represents the legal reason metadata for an ODM element."
},
"Location1":{
"type":"object",
"properties":{
"metaDataVersionRef":{
"type":"object",
"properties":{
"studyOID":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
"metaDataVersionOID":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the metadata version.",
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF11"
},
"effectiveDate":{
"type":"string",
"description":"Effective date for this metadata version in YYYY-MM-DD format.",
"example":"2025-01-31"
},
"effectiveDateTime":{
"type":"string",
"description":"Effective date and time for this metadata version in ISO-8601 format.",
"example":"2025-01-31T10:15:30Z"
}
},
"description":"Reference to a specific study metadata version with effective date information."
},
"name":{
"type":"string",
"description":"Name of the location.",
"example":"Main Site"
},
"locationType":{
"type":"string",
"description":"Type of location.",
"example":"OTHER",
"enum":[
"SPONSOR",
"SITE",
"CRO",
"LAB",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"ID of the site or depot of the kit",
"example":"A8C41D8062A14FCC89EDA475C3E3AF12"
}
},
"description":"Represents a site or location entity within the ODM context."
},
"LocationRef1":{
"type":"object",
"properties":{
"LocationOID":{
"type":"string",
"description":"OID/ID for the associated location.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Reference to a study/site location for an ODM User."
},
"LoginName1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Login/account name for the user.",
"example":"INVEST001"
}
},
"description":"Login name or identifier for the ODM User."
},
"Meaning1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Coded meaning value.",
"example":"EXP"
},
"text":{
"type":"string",
"description":"Human-readable description of the meaning.",
"example":"Experimental arm"
}
},
"description":"Represents the meaning metadata for an ODM element."
},
"MeasurementUnit10":{
"type":"object",
"properties":{
"Symbol":{
"$ref":"#/components/schemas/Symbol10"
},
"Alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"Name":{
"type":"string",
"description":"Formal name of this measurement unit.",
"example":"mg/dL"
},
"OID":{
"type":"string",
"description":"Unique OID for this measurement unit. UUID uppercase hex.",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"A measurement unit reference used in study forms, such as mg/dL."
},
"MeasurementUnitRef1":{
"type":"object",
"properties":{
"MeasurementUnitOID":{
"type":"string",
"description":"OID of the referenced measurement unit",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Data captured for a Measurement Unit "
},
"MetaDataVersion10":{
"type":"object",
"properties":{
"include":{
"$ref":"#/components/schemas/Include10"
},
"protocol":{
"$ref":"#/components/schemas/Protocol10"
},
"studyEventDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formRef":{
"type":"object",
"properties":{
"formOID":{
"type":"string",
"description":"OID of the referenced form",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of this form in the event",
"format":"int32",
"example":1
},
"mandatory":{
"type":"string",
"description":"Is this form mandatory in the event?",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception",
"example":"43caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"FormRef metadata"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Event name",
"example":"Screening Event"
},
"repeating":{
"type":"string",
"description":"Whether this event may repeat",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"type":{
"type":"string",
"description":"Type of event",
"example":"SCHEDULED",
"enum":[
"Scheduled",
"Unscheduled",
"Common"
]
},
"category":{
"type":"string",
"description":"Event category",
"example":"Main"
},
"oid":{
"type":"string",
"description":"Unique identifier OID for the event",
"example":"SE1"
}
},
"description":"Study Event Def data"
},
"formDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemGroupRef":{
"type":"array",
"description":"Item group references for this form",
"items":{
"$ref":"#/components/schemas/ItemGroupRef1"
}
},
"archiveLayout":{
"type":"array",
"description":"Archive layouts defined for this form",
"items":{
"$ref":"#/components/schemas/ArchiveLayout1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the form",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"Form name",
"example":"Demographics"
},
"repeating":{
"type":"string",
"description":"Whether the form is repeating",
"enum":[
"Yes",
"No"
]
},
"hasIPR":{
"type":"boolean",
"description":"Indicates IPR exists for the form",
"example":true
},
"note":{
"type":"string",
"description":"Additional note for the form",
"example":"Requires supervisor review"
},
"revisionDate":{
"type":"string",
"description":"Form revision date",
"example":"2023-01-01"
},
"oid":{
"type":"string",
"description":"Form object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"id":{
"type":"string",
"description":"Form identifier",
"example":"9B9B96B684BA4822B98BFA612A070251"
}
},
"description":"Form definition containing item group references, archive layouts and metadata."
},
"itemGroupDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemRef":{
"type":"array",
"description":"References to Items within this ItemGroup",
"items":{
"$ref":"#/components/schemas/ItemRef1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the ItemGroup",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"ItemGroup name",
"example":"Demographics Group"
},
"repeating":{
"type":"string",
"description":"Whether the ItemGroup is repeating",
"enum":[
"Yes",
"No"
]
},
"isReferenceData":{
"type":"string",
"description":"Indicates whether the ItemGroup holds reference data",
"enum":[
"Yes",
"No"
]
},
"domain":{
"type":"string",
"description":"Domain name for the ItemGroup",
"example":"DM"
},
"origin":{
"type":"string",
"description":"Origin of the ItemGroup data",
"example":"Collected"
},
"role":{
"type":"string",
"description":"Role of the ItemGroup",
"example":"CRF"
},
"purpose":{
"type":"string",
"description":"Purpose of the ItemGroup",
"example":"Analysis"
},
"comment":{
"type":"string",
"description":"Additional comments for the ItemGroup",
"example":"No special handling"
},
"SASDatasetName":{
"type":"string",
"description":"SAS dataset name mapped for the ItemGroup",
"example":"DM"
},
"oid":{
"type":"string",
"description":"ItemGroup object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"ItemGroup definition containing item references and metadata."
},
"itemDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"question":{
"$ref":"#/components/schemas/Question1"
},
"externalQuestion":{
"$ref":"#/components/schemas/ExternalQuestion1"
},
"measurementUnitRef":{
"type":"object",
"properties":{
"MeasurementUnitOID":{
"type":"string",
"description":"OID of the referenced measurement unit",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Data captured for a Measurement Unit "
},
"rangeCheck":{
"type":"object",
"properties":{
"checkValue":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value to check in a range validation",
"example":"10"
}
},
"description":"A value used within a range validation."
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"measurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"errorMessage":{
"$ref":"#/components/schemas/ErrorMessage1"
},
"comparator":{
"type":"string",
"description":"Comparator operation",
"enum":[
"LT",
"LE",
"GT",
"GE",
"EQ",
"NE",
"IN",
"NOTIN"
]
},
"softHard":{
"type":"string",
"description":"Indicates hard or soft validation",
"enum":[
"SOFT",
"HARD"
]
}
},
"description":"Range check configuration for item validation."
},
"codeListRef":{
"$ref":"#/components/schemas/CodeListRef1"
},
"role":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value or name of the role",
"example":"DataEntry"
}
},
"description":"Represents the role associated with an item or definition."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"Name":{
"type":"string",
"description":"Item name",
"example":"DROPDOWN_03"
},
"DataType":{
"type":"string",
"description":"Data type (e.g., STRING, INT)",
"example":"string",
"enum":[
"integer",
"float",
"date",
"datetime",
"time",
"text",
"string",
"double",
"URI",
"boolean",
"hexBinary",
"base64Binary",
"hexFloat",
"base64Float",
"partialDate",
"partialTime",
"partialDatetime",
"durationDatetime",
"intervalDatetime",
"incompleteDatetime",
"incompleteDate",
"incompleteTime"
]
},
"Length":{
"type":"integer",
"description":"Length of string/numeric",
"format":"int32",
"example":255
},
"SignificantDigits":{
"type":"integer",
"description":"Number of significant digits",
"format":"int32",
"example":2
},
"Origin":{
"type":"string",
"description":"Item's origin data",
"example":"derived"
},
"Comment":{
"type":"string",
"description":"Free-text comment",
"example":"This is a calculated item."
},
"CaptionText":{
"type":"string",
"description":"UI caption text",
"example":"Please enter your name"
},
"ControlType":{
"type":"string",
"description":"UI control type",
"example":"TEXTBOX",
"enum":[
"pulldown",
"text",
"group",
"radiogroup",
"checkbox",
"calendar",
"element",
"calculated",
"instructionaltext",
"file"
]
},
"ControlLayout":{
"type":"string",
"description":"UI control layout style.Allowed values are INF_NOTDEFINED,INF_HORIZONTAL,INF_VERTICAL,INF_NOWRAP,INF_TWOCOLUMN,INF_THREECOLUMN",
"example":"INF_NOTDEFINED",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5"
]
},
"CaptionAlignment":{
"type":"string",
"description":"Caption alignment. Allowed Values are INF_NOTDEFINED ,INF_LEFT ,INF_CENTER ,INF_RIGHT ,INF_TOP ,INF_MIDDLE ,INF_BOTTOM",
"example":"INF_TOP",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5",
"6"
]
},
"InitialRowCount":{
"type":"string",
"description":"Initial number of rows",
"example":"1"
},
"DisplayMask":{
"type":"string",
"description":"Display mask for input",
"example":"999-99-9999"
},
"StartYear":{
"type":"string",
"description":"Start year for date input",
"example":"2000"
},
"EndYear":{
"type":"string",
"description":"End year for date input",
"example":"2025"
},
"UnknownMask":{
"type":"string",
"description":"Unknown input mask",
"example":"UNK"
},
"Calculated":{
"type":"string",
"description":"Is this item calculated?",
"example":"1"
},
"SelectionValue":{
"type":"string",
"description":"Selection value for this item",
"example":"Y"
},
"itemRef":{
"type":"object",
"properties":{
"itemOID":{
"type":"string",
"description":"OID of referenced item",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"keySequence":{
"type":"integer",
"description":"Key sequence for composite key",
"format":"int64",
"example":1
},
"methodOID":{
"type":"string",
"description":"Method OID for derivation",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"imputationMethodOID":{
"type":"string",
"description":"Imputation method OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"role":{
"type":"string",
"description":"Role of the referenced item",
"example":"DataEntry"
},
"roleCodeListOID":{
"type":"string",
"description":"OID for role code list",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of the item",
"format":"int64",
"example":2
},
"mandatory":{
"type":"string",
"description":"Is this item mandatory?",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception condition",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to an Item within an ItemGroup."
},
"IsDynamic":{
"type":"integer",
"description":"Is this item dynamic?",
"format":"int32",
"example":0
},
"IsSmartItem":{
"type":"integer",
"description":"Is this a smart item?",
"format":"int32",
"example":1
},
"SASFieldName":{
"type":"string",
"description":"Field name in SAS export",
"example":"HEIGHT_SAS"
},
"SDSVarName":{
"type":"string",
"description":"Field name in SDS export",
"example":"HEIGHT_SDS"
},
"OID":{
"type":"string",
"description":"Unique OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Item definition including question, code list, range checks and metadata."
},
"codeList":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"externalCodeList":{
"$ref":"#/components/schemas/ExternalCodeList1"
},
"enumeratedItem":{
"type":"object",
"properties":{
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"rank":{
"type":"number",
"description":"Optional rank for ordering",
"example":1
},
"orderNumber":{
"type":"integer",
"description":"Order number within the code list",
"format":"int64",
"example":1
}
},
"description":"Enumerated item value with optional ordering and aliases."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Code list name",
"example":"GENDER"
},
"dataType":{
"type":"string",
"description":"Code list data type",
"enum":[
"INTEGER",
"FLOAT",
"TEXT",
"STRING"
]
},
"SASFormatName":{
"type":"string",
"description":"SAS format name for the code list",
"example":"BEST12."
},
"codeListItem":{
"type":"object",
"properties":{
"decode":{
"$ref":"#/components/schemas/Decode1"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"orderNumber":{
"type":"integer",
"description":"Order number of this item",
"format":"int64",
"example":1
}
},
"description":"Represents a single code list item with decode and metadata."
},
"oid":{
"type":"string",
"description":"CodeList object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Code list definition including items or external mappings."
},
"imputationMethod":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Imputation method value",
"example":"MeanImputation"
},
"oid":{
"type":"string",
"description":"Imputation method object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Imputation method definition with value and identifier."
},
"presentation":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Presentation value",
"example":"Form Layout A"
},
"lang":{
"type":"string",
"description":"Language code",
"example":"en"
},
"oid":{
"type":"string",
"description":"Presentation object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Presentation metadata including value, identifier and language."
},
"conditionDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Condition name",
"example":"AgeGreaterThan18"
},
"oid":{
"type":"string",
"description":"Condition object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Condition definition containing formal expressions and metadata."
},
"methodDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Method name",
"example":"DeriveBMI"
},
"type":{
"type":"string",
"description":"Method type",
"enum":[
"COMPUTATION",
"IMPUTATION",
"TRANSPOSE",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"Method object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Method definition containing formal expressions and metadata."
},
"name":{
"type":"string",
"description":"Name of this study version",
"example":"Main Study MetaData v1"
},
"description":{
"type":"string",
"description":"Description of this study version",
"example":"Main Study Metadata for Diabetes Trial"
},
"oid":{
"type":"string",
"description":"Unique identifier for this MetaDataVersion",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Represents the metadata about the study"
},
"MetaDataVersionRef1":{
"type":"object",
"properties":{
"studyOID":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
"metaDataVersionOID":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the metadata version.",
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF11"
},
"effectiveDate":{
"type":"string",
"description":"Effective date for this metadata version in YYYY-MM-DD format.",
"example":"2025-01-31"
},
"effectiveDateTime":{
"type":"string",
"description":"Effective date and time for this metadata version in ISO-8601 format.",
"example":"2025-01-31T10:15:30Z"
}
},
"description":"Reference to a specific study metadata version with effective date information."
},
"MethodDef1":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Method name",
"example":"DeriveBMI"
},
"type":{
"type":"string",
"description":"Method type",
"enum":[
"COMPUTATION",
"IMPUTATION",
"TRANSPOSE",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"Method object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Method definition containing formal expressions and metadata."
},
"ODM1":{
"type":"object",
"properties":{
"Study":{
"type":"object",
"properties":{
"GlobalVariables":{
"$ref":"#/components/schemas/GlobalVariables10"
},
"BasicDefinitions":{
"$ref":"#/components/schemas/BasicDefinitions10"
},
"MetaDataVersion":{
"type":"object",
"properties":{
"include":{
"$ref":"#/components/schemas/Include10"
},
"protocol":{
"$ref":"#/components/schemas/Protocol10"
},
"studyEventDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formRef":{
"type":"object",
"properties":{
"formOID":{
"type":"string",
"description":"OID of the referenced form",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of this form in the event",
"format":"int32",
"example":1
},
"mandatory":{
"type":"string",
"description":"Is this form mandatory in the event?",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception",
"example":"43caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"FormRef metadata"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Event name",
"example":"Screening Event"
},
"repeating":{
"type":"string",
"description":"Whether this event may repeat",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"type":{
"type":"string",
"description":"Type of event",
"example":"SCHEDULED",
"enum":[
"Scheduled",
"Unscheduled",
"Common"
]
},
"category":{
"type":"string",
"description":"Event category",
"example":"Main"
},
"oid":{
"type":"string",
"description":"Unique identifier OID for the event",
"example":"SE1"
}
},
"description":"Study Event Def data"
},
"formDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemGroupRef":{
"type":"array",
"description":"Item group references for this form",
"items":{
"$ref":"#/components/schemas/ItemGroupRef1"
}
},
"archiveLayout":{
"type":"array",
"description":"Archive layouts defined for this form",
"items":{
"$ref":"#/components/schemas/ArchiveLayout1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the form",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"Form name",
"example":"Demographics"
},
"repeating":{
"type":"string",
"description":"Whether the form is repeating",
"enum":[
"Yes",
"No"
]
},
"hasIPR":{
"type":"boolean",
"description":"Indicates IPR exists for the form",
"example":true
},
"note":{
"type":"string",
"description":"Additional note for the form",
"example":"Requires supervisor review"
},
"revisionDate":{
"type":"string",
"description":"Form revision date",
"example":"2023-01-01"
},
"oid":{
"type":"string",
"description":"Form object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"id":{
"type":"string",
"description":"Form identifier",
"example":"9B9B96B684BA4822B98BFA612A070251"
}
},
"description":"Form definition containing item group references, archive layouts and metadata."
},
"itemGroupDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemRef":{
"type":"array",
"description":"References to Items within this ItemGroup",
"items":{
"$ref":"#/components/schemas/ItemRef1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the ItemGroup",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"ItemGroup name",
"example":"Demographics Group"
},
"repeating":{
"type":"string",
"description":"Whether the ItemGroup is repeating",
"enum":[
"Yes",
"No"
]
},
"isReferenceData":{
"type":"string",
"description":"Indicates whether the ItemGroup holds reference data",
"enum":[
"Yes",
"No"
]
},
"domain":{
"type":"string",
"description":"Domain name for the ItemGroup",
"example":"DM"
},
"origin":{
"type":"string",
"description":"Origin of the ItemGroup data",
"example":"Collected"
},
"role":{
"type":"string",
"description":"Role of the ItemGroup",
"example":"CRF"
},
"purpose":{
"type":"string",
"description":"Purpose of the ItemGroup",
"example":"Analysis"
},
"comment":{
"type":"string",
"description":"Additional comments for the ItemGroup",
"example":"No special handling"
},
"SASDatasetName":{
"type":"string",
"description":"SAS dataset name mapped for the ItemGroup",
"example":"DM"
},
"oid":{
"type":"string",
"description":"ItemGroup object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"ItemGroup definition containing item references and metadata."
},
"itemDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"question":{
"$ref":"#/components/schemas/Question1"
},
"externalQuestion":{
"$ref":"#/components/schemas/ExternalQuestion1"
},
"measurementUnitRef":{
"type":"object",
"properties":{
"MeasurementUnitOID":{
"type":"string",
"description":"OID of the referenced measurement unit",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Data captured for a Measurement Unit "
},
"rangeCheck":{
"type":"object",
"properties":{
"checkValue":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value to check in a range validation",
"example":"10"
}
},
"description":"A value used within a range validation."
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"measurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"errorMessage":{
"$ref":"#/components/schemas/ErrorMessage1"
},
"comparator":{
"type":"string",
"description":"Comparator operation",
"enum":[
"LT",
"LE",
"GT",
"GE",
"EQ",
"NE",
"IN",
"NOTIN"
]
},
"softHard":{
"type":"string",
"description":"Indicates hard or soft validation",
"enum":[
"SOFT",
"HARD"
]
}
},
"description":"Range check configuration for item validation."
},
"codeListRef":{
"$ref":"#/components/schemas/CodeListRef1"
},
"role":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value or name of the role",
"example":"DataEntry"
}
},
"description":"Represents the role associated with an item or definition."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"Name":{
"type":"string",
"description":"Item name",
"example":"DROPDOWN_03"
},
"DataType":{
"type":"string",
"description":"Data type (e.g., STRING, INT)",
"example":"string",
"enum":[
"integer",
"float",
"date",
"datetime",
"time",
"text",
"string",
"double",
"URI",
"boolean",
"hexBinary",
"base64Binary",
"hexFloat",
"base64Float",
"partialDate",
"partialTime",
"partialDatetime",
"durationDatetime",
"intervalDatetime",
"incompleteDatetime",
"incompleteDate",
"incompleteTime"
]
},
"Length":{
"type":"integer",
"description":"Length of string/numeric",
"format":"int32",
"example":255
},
"SignificantDigits":{
"type":"integer",
"description":"Number of significant digits",
"format":"int32",
"example":2
},
"Origin":{
"type":"string",
"description":"Item's origin data",
"example":"derived"
},
"Comment":{
"type":"string",
"description":"Free-text comment",
"example":"This is a calculated item."
},
"CaptionText":{
"type":"string",
"description":"UI caption text",
"example":"Please enter your name"
},
"ControlType":{
"type":"string",
"description":"UI control type",
"example":"TEXTBOX",
"enum":[
"pulldown",
"text",
"group",
"radiogroup",
"checkbox",
"calendar",
"element",
"calculated",
"instructionaltext",
"file"
]
},
"ControlLayout":{
"type":"string",
"description":"UI control layout style.Allowed values are INF_NOTDEFINED,INF_HORIZONTAL,INF_VERTICAL,INF_NOWRAP,INF_TWOCOLUMN,INF_THREECOLUMN",
"example":"INF_NOTDEFINED",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5"
]
},
"CaptionAlignment":{
"type":"string",
"description":"Caption alignment. Allowed Values are INF_NOTDEFINED ,INF_LEFT ,INF_CENTER ,INF_RIGHT ,INF_TOP ,INF_MIDDLE ,INF_BOTTOM",
"example":"INF_TOP",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5",
"6"
]
},
"InitialRowCount":{
"type":"string",
"description":"Initial number of rows",
"example":"1"
},
"DisplayMask":{
"type":"string",
"description":"Display mask for input",
"example":"999-99-9999"
},
"StartYear":{
"type":"string",
"description":"Start year for date input",
"example":"2000"
},
"EndYear":{
"type":"string",
"description":"End year for date input",
"example":"2025"
},
"UnknownMask":{
"type":"string",
"description":"Unknown input mask",
"example":"UNK"
},
"Calculated":{
"type":"string",
"description":"Is this item calculated?",
"example":"1"
},
"SelectionValue":{
"type":"string",
"description":"Selection value for this item",
"example":"Y"
},
"itemRef":{
"type":"object",
"properties":{
"itemOID":{
"type":"string",
"description":"OID of referenced item",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"keySequence":{
"type":"integer",
"description":"Key sequence for composite key",
"format":"int64",
"example":1
},
"methodOID":{
"type":"string",
"description":"Method OID for derivation",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"imputationMethodOID":{
"type":"string",
"description":"Imputation method OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"role":{
"type":"string",
"description":"Role of the referenced item",
"example":"DataEntry"
},
"roleCodeListOID":{
"type":"string",
"description":"OID for role code list",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of the item",
"format":"int64",
"example":2
},
"mandatory":{
"type":"string",
"description":"Is this item mandatory?",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception condition",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to an Item within an ItemGroup."
},
"IsDynamic":{
"type":"integer",
"description":"Is this item dynamic?",
"format":"int32",
"example":0
},
"IsSmartItem":{
"type":"integer",
"description":"Is this a smart item?",
"format":"int32",
"example":1
},
"SASFieldName":{
"type":"string",
"description":"Field name in SAS export",
"example":"HEIGHT_SAS"
},
"SDSVarName":{
"type":"string",
"description":"Field name in SDS export",
"example":"HEIGHT_SDS"
},
"OID":{
"type":"string",
"description":"Unique OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Item definition including question, code list, range checks and metadata."
},
"codeList":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"externalCodeList":{
"$ref":"#/components/schemas/ExternalCodeList1"
},
"enumeratedItem":{
"type":"object",
"properties":{
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"rank":{
"type":"number",
"description":"Optional rank for ordering",
"example":1
},
"orderNumber":{
"type":"integer",
"description":"Order number within the code list",
"format":"int64",
"example":1
}
},
"description":"Enumerated item value with optional ordering and aliases."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Code list name",
"example":"GENDER"
},
"dataType":{
"type":"string",
"description":"Code list data type",
"enum":[
"INTEGER",
"FLOAT",
"TEXT",
"STRING"
]
},
"SASFormatName":{
"type":"string",
"description":"SAS format name for the code list",
"example":"BEST12."
},
"codeListItem":{
"type":"object",
"properties":{
"decode":{
"$ref":"#/components/schemas/Decode1"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"orderNumber":{
"type":"integer",
"description":"Order number of this item",
"format":"int64",
"example":1
}
},
"description":"Represents a single code list item with decode and metadata."
},
"oid":{
"type":"string",
"description":"CodeList object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Code list definition including items or external mappings."
},
"imputationMethod":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Imputation method value",
"example":"MeanImputation"
},
"oid":{
"type":"string",
"description":"Imputation method object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Imputation method definition with value and identifier."
},
"presentation":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Presentation value",
"example":"Form Layout A"
},
"lang":{
"type":"string",
"description":"Language code",
"example":"en"
},
"oid":{
"type":"string",
"description":"Presentation object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Presentation metadata including value, identifier and language."
},
"conditionDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Condition name",
"example":"AgeGreaterThan18"
},
"oid":{
"type":"string",
"description":"Condition object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Condition definition containing formal expressions and metadata."
},
"methodDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Method name",
"example":"DeriveBMI"
},
"type":{
"type":"string",
"description":"Method type",
"enum":[
"COMPUTATION",
"IMPUTATION",
"TRANSPOSE",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"Method object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Method definition containing formal expressions and metadata."
},
"name":{
"type":"string",
"description":"Name of this study version",
"example":"Main Study MetaData v1"
},
"description":{
"type":"string",
"description":"Description of this study version",
"example":"Main Study Metadata for Diabetes Trial"
},
"oid":{
"type":"string",
"description":"Unique identifier for this MetaDataVersion",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Represents the metadata about the study"
},
"OID":{
"type":"string",
"description":"Unique object identifier for the study, uppercase HEX UUID.",
"example":"D5E16DD550CB4AD1B330E0D09B4B8F3F"
}
},
"description":"ODM Study object"
},
"AdminData":{
"type":"object",
"properties":{
"User":{
"type":"object",
"properties":{
"loginName":{
"$ref":"#/components/schemas/LoginName1"
},
"displayName":{
"$ref":"#/components/schemas/DisplayName1"
},
"fullName":{
"$ref":"#/components/schemas/FullName10"
},
"firstName":{
"$ref":"#/components/schemas/FirstName10"
},
"lastName":{
"$ref":"#/components/schemas/LastName10"
},
"organization":{
"$ref":"#/components/schemas/Organization10"
},
"address":{
"type":"object",
"properties":{
"streetName":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Street name line.",
"example":"123 Main Street"
}
},
"description":"Street name component of a postal address."
},
"city":{
"$ref":"#/components/schemas/City1"
},
"stateProv":{
"$ref":"#/components/schemas/StateProv1"
},
"country":{
"$ref":"#/components/schemas/Country1"
},
"postalCode":{
"$ref":"#/components/schemas/PostalCode1"
},
"otherText":{
"$ref":"#/components/schemas/OtherText1"
}
},
"description":"Postal or location address for an ODM user or site, with support for street, city, state, country, and postal code."
},
"email":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Email address.",
"example":"john.smith@email.com"
}
},
"description":"Email address record for an ODM user."
},
"picture":{
"$ref":"#/components/schemas/Picture1"
},
"pager":{
"$ref":"#/components/schemas/Pager1"
},
"fax":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Fax number.",
"example":"555-5678"
}
},
"description":"Fax number/contact for an ODM User."
},
"phone":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Phone number.",
"example":"555-9876"
}
},
"description":"Phone number/contact entry for ODM User."
},
"locationRef":{
"type":"object",
"properties":{
"LocationOID":{
"type":"string",
"description":"OID/ID for the associated location.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Reference to a study/site location for an ODM User."
},
"certificate":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Certificate/credential identifier.",
"example":"CERT123"
}
},
"description":"Digital certificate or identity for an ODM User."
},
"userType":{
"type":"string",
"description":"Enumeration of possible user types/roles for ODM User.",
"enum":[
"SPONSOR",
"INVESTIGATOR",
"LAB",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"User OID value ",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Represents a user in the ODM AdminData structure (site personnel, investigator, etc)."
},
"Location":{
"type":"object",
"properties":{
"metaDataVersionRef":{
"type":"object",
"properties":{
"studyOID":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0C7CBA3F70034C47947E2FAB086BFBF5"
},
"metaDataVersionOID":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the metadata version.",
"example":"A1B2C3D4E5F6478899AABBCCDDEEFF11"
},
"effectiveDate":{
"type":"string",
"description":"Effective date for this metadata version in YYYY-MM-DD format.",
"example":"2025-01-31"
},
"effectiveDateTime":{
"type":"string",
"description":"Effective date and time for this metadata version in ISO-8601 format.",
"example":"2025-01-31T10:15:30Z"
}
},
"description":"Reference to a specific study metadata version with effective date information."
},
"name":{
"type":"string",
"description":"Name of the location.",
"example":"Main Site"
},
"locationType":{
"type":"string",
"description":"Type of location.",
"example":"OTHER",
"enum":[
"SPONSOR",
"SITE",
"CRO",
"LAB",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"ID of the site or depot of the kit",
"example":"A8C41D8062A14FCC89EDA475C3E3AF12"
}
},
"description":"Represents a site or location entity within the ODM context."
},
"SignatureDef":{
"type":"object",
"properties":{
"group":{
"type":"string",
"description":"Signature group or category.",
"example":"INVESTIGATOR"
},
"type":{
"type":"string",
"description":"Signature type.",
"example":"DIGITAL"
},
"meaning":{
"$ref":"#/components/schemas/Meaning1"
},
"legalReason":{
"$ref":"#/components/schemas/LegalReason1"
},
"oid":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"Definition of a signature including meaning, legal reason, and identifiers."
},
"StudyOID":{
"type":"string",
"description":"Study OID to which this admin data refers.",
"example":"D5E16DD550CB4AD1B330E0D09B4B8F3F"
}
},
"description":"ODM AdminData section: definition of users, locations, digital signatures, and study OID metadata."
},
"ReferenceData":{
"type":"object",
"properties":{
"ItemGroupData":{
"type":"object",
"properties":{
"auditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"signature":{
"$ref":"#/components/schemas/Signature1"
},
"annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"items":{
"type":"object",
"properties":{
"AuditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"Signature":{
"$ref":"#/components/schemas/Signature1"
},
"MeasurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"Annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"ItemOID":{
"type":"string",
"description":"OID of the item",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"TransactionType":{
"type":"string",
"description":"Transaction type- INSERT, UPDATE, REMOVE, UPSERT or CONTEXT",
"example":"UPDATE",
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
},
"ParentItemOID":{
"type":"string",
"description":"OID of parent item",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"NotDone":{
"type":"string",
"description":"Whether item is not done (0 or 1)",
"example":"0"
},
"SelectedCodeListItemsType":{
"type":"string",
"description":"Selected code list items type",
"example":"CODE_A"
},
"Value":{
"type":"string",
"description":"Value for this item",
"example":"130"
},
"DocumentId":{
"type":"string",
"description":"Document ID reference",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"DocumentVersion":{
"type":"number",
"description":"Document version",
"example":1
}
},
"description":"Data captured for a Item "
},
"itemGroupOID":{
"type":"string",
"description":"OID for this item group",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"itemGroupRepeatKey":{
"type":"string",
"description":"Repeat key for this group",
"example":"RPT1"
},
"transactionType":{
"type":"string",
"description":"Transaction type for the group",
"example":"INSERT",
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
}
},
"description":"Data captured for a Item Group"
},
"AuditRecords":{
"type":"object",
"properties":{
"auditRecord":{
"type":"array",
"description":"List of audit records associated with the subject or form.",
"items":{
"$ref":"#/components/schemas/AuditRecord100"
}
}
},
"description":"Container for a list of ODM audit record entries."
},
"Signatures":{
"type":"object",
"properties":{
"signature":{
"type":"array",
"description":"List of signature entries associated with the ODM structure.",
"items":{
"$ref":"#/components/schemas/Signature1"
}
}
},
"description":"Container for a list of ODM Signature entries."
},
"Annotations":{
"type":"object",
"properties":{
"annotation":{
"type":"array",
"description":"List of Annotation entries associated to the ODM structure.",
"items":{
"$ref":"#/components/schemas/Annotation2"
}
}
},
"description":"Container for a list of ODM Annotation entries."
},
"StudyOID":{
"type":"string",
"description":"OID of referenced study",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"MetaDataVersionOID":{
"type":"string",
"description":"OID for referenced MetaDataVersion",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"ReferenceData DTO."
},
"ClinicalData":{
"type":"object",
"properties":{
"subjectData":{
"type":"array",
"description":"List of subject-level clinical data records",
"items":{
"$ref":"#/components/schemas/SubjectData1"
}
},
"auditRecords":{
"type":"array",
"description":"List of audit records associated with clinical data",
"items":{
"$ref":"#/components/schemas/AuditRecords1"
}
},
"Signatures":{
"type":"array",
"description":"List of digital signatures applied to the clinical data",
"items":{
"$ref":"#/components/schemas/Signatures1"
}
},
"Annotations":{
"type":"array",
"description":"List of annotations attached to the clinical data",
"items":{
"$ref":"#/components/schemas/Annotations1"
}
},
"StudyOID":{
"type":"string",
"description":"Study OID for which this clinical data applies",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"MetaDataVersionOID":{
"type":"string",
"description":"Metadata version OID associated with the study design",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"ODM ClinicalData section containing study OID, metadata version OID, and lists of subject data, audit records, signatures, and annotations."
},
"Association":{
"type":"object",
"properties":{
"content":{
"type":"array",
"description":"List of associated elements",
"example":[
],
"items":{
"type":"object",
"description":"List of associated elements",
"example":[
]
}
},
"studyOID":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2.0.0.39.222eabde-1b96-48f6-9d3b-6250880a2b09"
},
"metaDataVersionOID":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
}
},
"description":"Association between study and metadata version with embedded content"
},
"Signature":{
"type":"object",
"properties":{
"signedInfo":{
"$ref":"#/components/schemas/SignedInfoType1"
},
"signatureValue":{
"$ref":"#/components/schemas/SignatureValueType1"
},
"keyInfo":{
"$ref":"#/components/schemas/KeyInfoType1"
},
"object":{
"type":"object",
"properties":{
"content":{
"type":"array",
"description":"List of embedded content",
"example":[
],
"items":{
"type":"object",
"description":"List of embedded content",
"example":[
]
}
},
"mimeType":{
"type":"string",
"description":"MIME type of the encapsulated content",
"example":"application/pdf"
},
"encoding":{
"type":"string",
"description":"Character encoding of the content",
"example":"UTF-8"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"3F2504E04F8911D39A0C0305E82C3301"
}
},
"description":"Generic container for embedded object content and metadata"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"XML Digital Signature container including SignedInfo, SignatureValue, KeyInfo and optional Object elements."
},
"Description":{
"type":"string",
"description":"Description of this ODM payload/report.",
"example":"CRF Report ODM data for sample study."
},
"FileType":{
"type":"string",
"description":"Output file type of ODM report.The values can be SNAPSHOT or TRANSACTIONAL",
"example":"SNAPSHOT"
},
"Granularity":{
"type":"string",
"description":"Granularity of report (e.g. ALL, SUBJECT, VISIT).",
"example":"ALL"
},
"Archival":{
"type":"string",
"description":"Archival indicator (YES or NO).",
"example":"YES"
},
"FileOID":{
"type":"string",
"description":"File OID of generated ODM file. (UUID uppercase hex format)",
"example":"FFBAA1C5287D40679B1ED676151C7F63"
},
"CreationDateTime":{
"type":"string",
"description":"ISO timestamp for creation of this ODM.",
"example":"2025-10-27T10:00:00Z"
},
"PriorFileOID":{
"type":"string",
"description":"File OID of the prior ODM in the generation sequence.",
"example":"9678B5A2C18C4A20A1400729839CC661"
},
"AsOfDateTime":{
"type":"string",
"description":"As-of timestamp for this ODM.",
"example":"2025-10-26T23:59:59Z"
},
"Originator":{
"type":"string",
"description":"Originating system for ODM.",
"example":"ORACLE_CDM_SYSTEM"
},
"SourceSystem":{
"type":"string",
"description":"Source system identifier.",
"example":"ClinicalOne"
},
"SourceSystemVersion":{
"type":"string",
"description":"Source system version.",
"example":"3.0.0.0"
},
"ODMVersion":{
"type":"string",
"description":"ODM version spec string.",
"example":"1.3.2"
},
"ID":{
"type":"string",
"description":"Unique report/package identifier (UUID uppercase hex format).",
"example":"71C8CED11E264FFDB165B07AF5117602"
}
},
"description":"Oracle Clinical Data Management model object for CRF report result data, including study, admin, reference, clinical, and associated metadata."
},
"ObjectType10":{
"type":"object",
"properties":{
"content":{
"type":"array",
"description":"List of embedded content",
"example":[
],
"items":{
"type":"object",
"description":"List of embedded content",
"example":[
]
}
},
"mimeType":{
"type":"string",
"description":"MIME type of the encapsulated content",
"example":"application/pdf"
},
"encoding":{
"type":"string",
"description":"Character encoding of the content",
"example":"UTF-8"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"3F2504E04F8911D39A0C0305E82C3301"
}
},
"description":"Generic container for embedded object content and metadata"
},
"Organization10":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Name of the user's organization.",
"example":"Site 101 Hospital"
}
},
"description":"Organization name associated with the User."
},
"OtherText1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Additional address text.",
"example":"Apt 4B"
}
},
"description":"Additional address information or notes."
},
"Pager1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Pager contact number or info.",
"example":"555-1234"
}
},
"description":"Pager number or contact info for an ODM User."
},
"Phone":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Phone number.",
"example":"555-9876"
}
},
"description":"Phone number/contact entry for ODM User."
},
"Picture1":{
"type":"object",
"properties":{
"pictureFileName":{
"type":"string",
"description":"Picture filename or image reference.",
"example":"photo.jpg"
},
"imageType":{
"type":"string",
"description":"MIME/image type information, e.g. image/jpeg",
"example":"image/jpeg"
}
},
"description":"Profile or avatar image info for ODM User."
},
"PostalCode1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Postal or ZIP code.",
"example":"94043"
}
},
"description":"Postal or ZIP code component of a postal address."
},
"Presentation1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Presentation value",
"example":"Form Layout A"
},
"lang":{
"type":"string",
"description":"Language code",
"example":"en"
},
"oid":{
"type":"string",
"description":"Presentation object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Presentation metadata including value, identifier and language."
},
"Protocol10":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"studyEventRef":{
"type":"object",
"properties":{
"orderNumber":{
"type":"integer",
"description":"Order of the event in schedule",
"format":"int32",
"example":1
},
"mandatory":{
"type":"string",
"description":"Is this event mandatory? YES or NO",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception",
"example":"COND1"
},
"studyEventOID":{
"type":"string",
"description":"OID of the referenced study event",
"example":"SE1"
}
},
"description":"Study Event Ref data",
"example":[
{
"eventOID":"SE1"
}
]
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit.",
"example":[
{
"context":"CDASH",
"name":"PROTID"
}
]
}
},
"description":"Protocol metadata"
},
"ProtocolName10":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Protocol name/code for the Study.",
"example":"P-2024-0001"
}
},
"description":"Protocol identifier/name for the ODM Study."
},
"Question1":{
"type":"object",
"properties":{
"translatedText":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Text value for this locale/language.",
"example":"gender"
},
"lang":{
"type":"string",
"description":"Language code for this translation, e.g. 'en'.",
"example":"null"
}
},
"description":"A localizable or translated representation of a symbol, label, or similar text element."
}
},
"description":"Question containing translated display text."
},
"RangeCheck1":{
"type":"object",
"properties":{
"checkValue":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value to check in a range validation",
"example":"10"
}
},
"description":"A value used within a range validation."
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"measurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"errorMessage":{
"$ref":"#/components/schemas/ErrorMessage1"
},
"comparator":{
"type":"string",
"description":"Comparator operation",
"enum":[
"LT",
"LE",
"GT",
"GE",
"EQ",
"NE",
"IN",
"NOTIN"
]
},
"softHard":{
"type":"string",
"description":"Indicates hard or soft validation",
"enum":[
"SOFT",
"HARD"
]
}
},
"description":"Range check configuration for item validation."
},
"ReasonForChange1":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Free-text reason describing the change.",
"example":"Correction of data entry error"
}
},
"description":"Explanation provided to justify why a data value was created or modified."
},
"ReferenceData10":{
"type":"object",
"properties":{
"ItemGroupData":{
"type":"object",
"properties":{
"auditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"signature":{
"$ref":"#/components/schemas/Signature1"
},
"annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"items":{
"type":"object",
"properties":{
"AuditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"Signature":{
"$ref":"#/components/schemas/Signature1"
},
"MeasurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"Annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment2"
},
"flag":{
"type":"object",
"properties":{
"FlagValue":{
"$ref":"#/components/schemas/FlagValue1"
},
"FlagType":{
"$ref":"#/components/schemas/FlagType1"
}
},
"description":"Annotation flag consisting of a type and value to classify or qualify data (e.g., Query, Review Required)."
},
"seqNum":{
"type":"integer",
"description":"Sequence number ordering annotations within the same context.",
"format":"int64",
"example":1
},
"transactionType":{
"type":"string",
"description":"Operation represented by this annotation (Example values are- INSERT, UPDATE, DELETE, REMOVE,UPSERT,CONTEXT).",
"example":"INSERT"
},
"id":{
"type":"string",
"description":"Annotation identifier unique within the context.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Note, query, or other annotation associated with a data point, including flags and a comment."
},
"ItemOID":{
"type":"string",
"description":"OID of the item",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"TransactionType":{
"type":"string",
"description":"Transaction type- INSERT, UPDATE, REMOVE, UPSERT or CONTEXT",
"example":"UPDATE",
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
},
"ParentItemOID":{
"type":"string",
"description":"OID of parent item",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"NotDone":{
"type":"string",
"description":"Whether item is not done (0 or 1)",
"example":"0"
},
"SelectedCodeListItemsType":{
"type":"string",
"description":"Selected code list items type",
"example":"CODE_A"
},
"Value":{
"type":"string",
"description":"Value for this item",
"example":"130"
},
"DocumentId":{
"type":"string",
"description":"Document ID reference",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"DocumentVersion":{
"type":"number",
"description":"Document version",
"example":1
}
},
"description":"Data captured for a Item "
},
"itemGroupOID":{
"type":"string",
"description":"OID for this item group",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"itemGroupRepeatKey":{
"type":"string",
"description":"Repeat key for this group",
"example":"RPT1"
},
"transactionType":{
"type":"string",
"description":"Transaction type for the group",
"example":"INSERT",
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
}
},
"description":"Data captured for a Item Group"
},
"AuditRecords":{
"type":"object",
"properties":{
"auditRecord":{
"type":"array",
"description":"List of audit records associated with the subject or form.",
"items":{
"$ref":"#/components/schemas/AuditRecord100"
}
}
},
"description":"Container for a list of ODM audit record entries."
},
"Signatures":{
"type":"object",
"properties":{
"signature":{
"type":"array",
"description":"List of signature entries associated with the ODM structure.",
"items":{
"$ref":"#/components/schemas/Signature1"
}
}
},
"description":"Container for a list of ODM Signature entries."
},
"Annotations":{
"type":"object",
"properties":{
"annotation":{
"type":"array",
"description":"List of Annotation entries associated to the ODM structure.",
"items":{
"$ref":"#/components/schemas/Annotation2"
}
}
},
"description":"Container for a list of ODM Annotation entries."
},
"StudyOID":{
"type":"string",
"description":"OID of referenced study",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"MetaDataVersionOID":{
"type":"string",
"description":"OID for referenced MetaDataVersion",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"ReferenceData DTO."
},
"ReferenceType1":{
"type":"object",
"properties":{
"transforms":{
"$ref":"#/components/schemas/TransformsType1"
},
"digestMethod":{
"$ref":"#/components/schemas/DigestMethodType1"
},
"digestValue":{
"type":"string",
"description":"Base64-encoded digest value of the referenced data.",
"format":"byte",
"example":"WVdKak1USXo="
},
"uri":{
"type":"string",
"description":"URI of the referenced resource.",
"example":"#object"
},
"type":{
"type":"string",
"description":"Type of the reference, typically a URI indicating the nature of the resource.",
"example":"http://www.w3.org/2000/09/xmldsig#Object"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"Reference to signed data including transforms, digest method, and digest value."
},
"RepeatingFormData1":{
"type":"object",
"properties":{
"formOID":{
"type":"string",
"description":"Identifier (OID) of the repeating form definition.",
"format":"oid",
"example":"95dc21fd-e522-4cc6-9d94-92ece0f25120.1_8_0_29"
},
"formID":{
"type":"string",
"description":"Human-readable identifier for the form instance.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"formHeader":{
"type":"array",
"description":"Header section for the repeating form instance (metadata about the form).",
"items":{
"$ref":"#/components/schemas/FormHeader1"
}
},
"Row":{
"type":"array",
"description":"Rows comprising items captured in this form instance.",
"items":{
"$ref":"#/components/schemas/Row2"
}
},
"summaryNote":{
"type":"string",
"description":"Optional summary or note for the form instance.",
"example":"Patient reported mild headache."
}
},
"description":"A single repeating form instance including headers and rows of item data."
},
"RepeatingFormSummary1":{
"type":"object",
"properties":{
"repeatingFormData":{
"type":"array",
"description":"Collection of repeating form data entries.",
"items":{
"$ref":"#/components/schemas/RepeatingFormData1"
}
}
},
"description":"Summary container for sets of repeating forms within a study event."
},
"Role1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value or name of the role",
"example":"DataEntry"
}
},
"description":"Represents the role associated with an item or definition."
},
"Row2":{
"type":"object",
"properties":{
"associatedFormList":{
"type":"array",
"description":"List of forms associated with this row, if any.",
"items":{
"$ref":"#/components/schemas/AssociatedFormList1"
}
},
"rowNo":{
"type":"string",
"description":"Row sequence identifier within the repeating form.",
"example":"1"
},
"formIndex":{
"type":"string",
"description":"Index value used to order or group rows.",
"example":"1"
},
"associated":{
"type":"boolean",
"description":"Indicates whether the row is associated to another form or entity.",
"example":true
},
"deleted":{
"type":"string",
"description":"Marks the row as logically deleted.",
"example":"false"
},
"item":{
"type":"array",
"description":"Items captured within this row.",
"items":{
"$ref":"#/components/schemas/Item1"
}
}
},
"description":"A single row within a repeating form instance containing associated forms and item data."
},
"Signature1":{
"type":"object",
"properties":{
"UserRef":{
"$ref":"#/components/schemas/UserRef10"
},
"LocationRef":{
"$ref":"#/components/schemas/LocationRef1"
},
"SignatureRef":{
"$ref":"#/components/schemas/SignatureRef1"
},
"DateTimeStamp":{
"$ref":"#/components/schemas/DateTimeStamp1"
},
"CryptoBindingManifest":{
"$ref":"#/components/schemas/CryptoBindingManifest10"
},
"ID":{
"type":"string",
"description":"Signature identifier",
"format":"identifier",
"example":"SIG123"
}
},
"description":"Digital signature record including signer, location, timestamp, and cryptographic binding manifest."
},
"SignatureDef1":{
"type":"object",
"properties":{
"group":{
"type":"string",
"description":"Signature group or category.",
"example":"INVESTIGATOR"
},
"type":{
"type":"string",
"description":"Signature type.",
"example":"DIGITAL"
},
"meaning":{
"$ref":"#/components/schemas/Meaning1"
},
"legalReason":{
"$ref":"#/components/schemas/LegalReason1"
},
"oid":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"Definition of a signature including meaning, legal reason, and identifiers."
},
"SignatureMethodType1":{
"type":"object",
"properties":{
"content":{
"type":"object",
"description":"Optional content/parameters for the SignatureMethod."
},
"algorithm":{
"type":"string",
"description":"Signature algorithm URI.",
"example":"Algo1"
}
},
"description":"Signature algorithm definition and associated parameters for XML Digital Signatures."
},
"SignatureRef1":{
"type":"object",
"properties":{
"SignatureOID":{
"type":"string",
"description":"Identifier (OID) of the referenced signature.",
"example":"SIG-0001"
}
},
"description":"Reference to a signature object used to approve or verify data."
},
"SignatureType1":{
"type":"object",
"properties":{
"signedInfo":{
"$ref":"#/components/schemas/SignedInfoType1"
},
"signatureValue":{
"$ref":"#/components/schemas/SignatureValueType1"
},
"keyInfo":{
"$ref":"#/components/schemas/KeyInfoType1"
},
"object":{
"type":"object",
"properties":{
"content":{
"type":"array",
"description":"List of embedded content",
"example":[
],
"items":{
"type":"object",
"description":"List of embedded content",
"example":[
]
}
},
"mimeType":{
"type":"string",
"description":"MIME type of the encapsulated content",
"example":"application/pdf"
},
"encoding":{
"type":"string",
"description":"Character encoding of the content",
"example":"UTF-8"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"3F2504E04F8911D39A0C0305E82C3301"
}
},
"description":"Generic container for embedded object content and metadata"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"XML Digital Signature container including SignedInfo, SignatureValue, KeyInfo and optional Object elements."
},
"SignatureValueType1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Base64-encoded signature value.",
"format":"byte"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"The actual value of the digital signature and optional identifier."
},
"Signatures1":{
"type":"object",
"properties":{
"signature":{
"type":"array",
"description":"List of signature entries associated with the ODM structure.",
"items":{
"$ref":"#/components/schemas/Signature1"
}
}
},
"description":"Container for a list of ODM Signature entries."
},
"SignedInfoType1":{
"type":"object",
"properties":{
"canonicalizationMethod":{
"$ref":"#/components/schemas/CanonicalizationMethodType1"
},
"signatureMethod":{
"$ref":"#/components/schemas/SignatureMethodType1"
},
"reference":{
"type":"object",
"properties":{
"transforms":{
"$ref":"#/components/schemas/TransformsType1"
},
"digestMethod":{
"$ref":"#/components/schemas/DigestMethodType1"
},
"digestValue":{
"type":"string",
"description":"Base64-encoded digest value of the referenced data.",
"format":"byte",
"example":"WVdKak1USXo="
},
"uri":{
"type":"string",
"description":"URI of the referenced resource.",
"example":"#object"
},
"type":{
"type":"string",
"description":"Type of the reference, typically a URI indicating the nature of the resource.",
"example":"http://www.w3.org/2000/09/xmldsig#Object"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"Reference to signed data including transforms, digest method, and digest value."
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"Contains canonicalization and signature methods, and references used in the XML Digital Signature."
},
"SiteRef10":{
"type":"object",
"properties":{
"LocationOID":{
"type":"string",
"description":"Identifier (OID) of the site location.",
"format":"oid",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
},
"Name":{
"type":"string",
"description":"Human-readable site name.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Reference to a study site/location."
},
"SourceID1":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Source identifier value (e.g., system code or external app ID).",
"format":"identifier",
"example":"SYS"
}
},
"description":"Identifier of the originating system or source that provided the data."
},
"StateProv1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"State or province code or name.",
"example":"CA"
}
},
"description":"State or province component of a postal address."
},
"StreetName1":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Street name line.",
"example":"123 Main Street"
}
},
"description":"Street name component of a postal address."
},
"Study":{
"type":"object",
"properties":{
"GlobalVariables":{
"$ref":"#/components/schemas/GlobalVariables10"
},
"BasicDefinitions":{
"$ref":"#/components/schemas/BasicDefinitions10"
},
"MetaDataVersion":{
"type":"object",
"properties":{
"include":{
"$ref":"#/components/schemas/Include10"
},
"protocol":{
"$ref":"#/components/schemas/Protocol10"
},
"studyEventDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formRef":{
"type":"object",
"properties":{
"formOID":{
"type":"string",
"description":"OID of the referenced form",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of this form in the event",
"format":"int32",
"example":1
},
"mandatory":{
"type":"string",
"description":"Is this form mandatory in the event?",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception",
"example":"43caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"FormRef metadata"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Event name",
"example":"Screening Event"
},
"repeating":{
"type":"string",
"description":"Whether this event may repeat",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"type":{
"type":"string",
"description":"Type of event",
"example":"SCHEDULED",
"enum":[
"Scheduled",
"Unscheduled",
"Common"
]
},
"category":{
"type":"string",
"description":"Event category",
"example":"Main"
},
"oid":{
"type":"string",
"description":"Unique identifier OID for the event",
"example":"SE1"
}
},
"description":"Study Event Def data"
},
"formDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemGroupRef":{
"type":"array",
"description":"Item group references for this form",
"items":{
"$ref":"#/components/schemas/ItemGroupRef1"
}
},
"archiveLayout":{
"type":"array",
"description":"Archive layouts defined for this form",
"items":{
"$ref":"#/components/schemas/ArchiveLayout1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the form",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"Form name",
"example":"Demographics"
},
"repeating":{
"type":"string",
"description":"Whether the form is repeating",
"enum":[
"Yes",
"No"
]
},
"hasIPR":{
"type":"boolean",
"description":"Indicates IPR exists for the form",
"example":true
},
"note":{
"type":"string",
"description":"Additional note for the form",
"example":"Requires supervisor review"
},
"revisionDate":{
"type":"string",
"description":"Form revision date",
"example":"2023-01-01"
},
"oid":{
"type":"string",
"description":"Form object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"id":{
"type":"string",
"description":"Form identifier",
"example":"9B9B96B684BA4822B98BFA612A070251"
}
},
"description":"Form definition containing item group references, archive layouts and metadata."
},
"itemGroupDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"itemRef":{
"type":"array",
"description":"References to Items within this ItemGroup",
"items":{
"$ref":"#/components/schemas/ItemRef1"
}
},
"alias":{
"type":"array",
"description":"Aliases for the ItemGroup",
"items":{
"$ref":"#/components/schemas/Alias1"
}
},
"name":{
"type":"string",
"description":"ItemGroup name",
"example":"Demographics Group"
},
"repeating":{
"type":"string",
"description":"Whether the ItemGroup is repeating",
"enum":[
"Yes",
"No"
]
},
"isReferenceData":{
"type":"string",
"description":"Indicates whether the ItemGroup holds reference data",
"enum":[
"Yes",
"No"
]
},
"domain":{
"type":"string",
"description":"Domain name for the ItemGroup",
"example":"DM"
},
"origin":{
"type":"string",
"description":"Origin of the ItemGroup data",
"example":"Collected"
},
"role":{
"type":"string",
"description":"Role of the ItemGroup",
"example":"CRF"
},
"purpose":{
"type":"string",
"description":"Purpose of the ItemGroup",
"example":"Analysis"
},
"comment":{
"type":"string",
"description":"Additional comments for the ItemGroup",
"example":"No special handling"
},
"SASDatasetName":{
"type":"string",
"description":"SAS dataset name mapped for the ItemGroup",
"example":"DM"
},
"oid":{
"type":"string",
"description":"ItemGroup object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"ItemGroup definition containing item references and metadata."
},
"itemDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"question":{
"$ref":"#/components/schemas/Question1"
},
"externalQuestion":{
"$ref":"#/components/schemas/ExternalQuestion1"
},
"measurementUnitRef":{
"type":"object",
"properties":{
"MeasurementUnitOID":{
"type":"string",
"description":"OID of the referenced measurement unit",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Data captured for a Measurement Unit "
},
"rangeCheck":{
"type":"object",
"properties":{
"checkValue":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value to check in a range validation",
"example":"10"
}
},
"description":"A value used within a range validation."
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"measurementUnitRef":{
"$ref":"#/components/schemas/MeasurementUnitRef1"
},
"errorMessage":{
"$ref":"#/components/schemas/ErrorMessage1"
},
"comparator":{
"type":"string",
"description":"Comparator operation",
"enum":[
"LT",
"LE",
"GT",
"GE",
"EQ",
"NE",
"IN",
"NOTIN"
]
},
"softHard":{
"type":"string",
"description":"Indicates hard or soft validation",
"enum":[
"SOFT",
"HARD"
]
}
},
"description":"Range check configuration for item validation."
},
"codeListRef":{
"$ref":"#/components/schemas/CodeListRef1"
},
"role":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Value or name of the role",
"example":"DataEntry"
}
},
"description":"Represents the role associated with an item or definition."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"Name":{
"type":"string",
"description":"Item name",
"example":"DROPDOWN_03"
},
"DataType":{
"type":"string",
"description":"Data type (e.g., STRING, INT)",
"example":"string",
"enum":[
"integer",
"float",
"date",
"datetime",
"time",
"text",
"string",
"double",
"URI",
"boolean",
"hexBinary",
"base64Binary",
"hexFloat",
"base64Float",
"partialDate",
"partialTime",
"partialDatetime",
"durationDatetime",
"intervalDatetime",
"incompleteDatetime",
"incompleteDate",
"incompleteTime"
]
},
"Length":{
"type":"integer",
"description":"Length of string/numeric",
"format":"int32",
"example":255
},
"SignificantDigits":{
"type":"integer",
"description":"Number of significant digits",
"format":"int32",
"example":2
},
"Origin":{
"type":"string",
"description":"Item's origin data",
"example":"derived"
},
"Comment":{
"type":"string",
"description":"Free-text comment",
"example":"This is a calculated item."
},
"CaptionText":{
"type":"string",
"description":"UI caption text",
"example":"Please enter your name"
},
"ControlType":{
"type":"string",
"description":"UI control type",
"example":"TEXTBOX",
"enum":[
"pulldown",
"text",
"group",
"radiogroup",
"checkbox",
"calendar",
"element",
"calculated",
"instructionaltext",
"file"
]
},
"ControlLayout":{
"type":"string",
"description":"UI control layout style.Allowed values are INF_NOTDEFINED,INF_HORIZONTAL,INF_VERTICAL,INF_NOWRAP,INF_TWOCOLUMN,INF_THREECOLUMN",
"example":"INF_NOTDEFINED",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5"
]
},
"CaptionAlignment":{
"type":"string",
"description":"Caption alignment. Allowed Values are INF_NOTDEFINED ,INF_LEFT ,INF_CENTER ,INF_RIGHT ,INF_TOP ,INF_MIDDLE ,INF_BOTTOM",
"example":"INF_TOP",
"enum":[
"0",
"1",
"2",
"3",
"4",
"5",
"6"
]
},
"InitialRowCount":{
"type":"string",
"description":"Initial number of rows",
"example":"1"
},
"DisplayMask":{
"type":"string",
"description":"Display mask for input",
"example":"999-99-9999"
},
"StartYear":{
"type":"string",
"description":"Start year for date input",
"example":"2000"
},
"EndYear":{
"type":"string",
"description":"End year for date input",
"example":"2025"
},
"UnknownMask":{
"type":"string",
"description":"Unknown input mask",
"example":"UNK"
},
"Calculated":{
"type":"string",
"description":"Is this item calculated?",
"example":"1"
},
"SelectionValue":{
"type":"string",
"description":"Selection value for this item",
"example":"Y"
},
"itemRef":{
"type":"object",
"properties":{
"itemOID":{
"type":"string",
"description":"OID of referenced item",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"keySequence":{
"type":"integer",
"description":"Key sequence for composite key",
"format":"int64",
"example":1
},
"methodOID":{
"type":"string",
"description":"Method OID for derivation",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"imputationMethodOID":{
"type":"string",
"description":"Imputation method OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"role":{
"type":"string",
"description":"Role of the referenced item",
"example":"DataEntry"
},
"roleCodeListOID":{
"type":"string",
"description":"OID for role code list",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of the item",
"format":"int64",
"example":2
},
"mandatory":{
"type":"string",
"description":"Is this item mandatory?",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception condition",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to an Item within an ItemGroup."
},
"IsDynamic":{
"type":"integer",
"description":"Is this item dynamic?",
"format":"int32",
"example":0
},
"IsSmartItem":{
"type":"integer",
"description":"Is this a smart item?",
"format":"int32",
"example":1
},
"SASFieldName":{
"type":"string",
"description":"Field name in SAS export",
"example":"HEIGHT_SAS"
},
"SDSVarName":{
"type":"string",
"description":"Field name in SDS export",
"example":"HEIGHT_SDS"
},
"OID":{
"type":"string",
"description":"Unique OID",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Item definition including question, code list, range checks and metadata."
},
"codeList":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"externalCodeList":{
"$ref":"#/components/schemas/ExternalCodeList1"
},
"enumeratedItem":{
"type":"object",
"properties":{
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"rank":{
"type":"number",
"description":"Optional rank for ordering",
"example":1
},
"orderNumber":{
"type":"integer",
"description":"Order number within the code list",
"format":"int64",
"example":1
}
},
"description":"Enumerated item value with optional ordering and aliases."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Code list name",
"example":"GENDER"
},
"dataType":{
"type":"string",
"description":"Code list data type",
"enum":[
"INTEGER",
"FLOAT",
"TEXT",
"STRING"
]
},
"SASFormatName":{
"type":"string",
"description":"SAS format name for the code list",
"example":"BEST12."
},
"codeListItem":{
"type":"object",
"properties":{
"decode":{
"$ref":"#/components/schemas/Decode1"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"codedValue":{
"type":"string",
"description":"Coded value",
"example":"M"
},
"orderNumber":{
"type":"integer",
"description":"Order number of this item",
"format":"int64",
"example":1
}
},
"description":"Represents a single code list item with decode and metadata."
},
"oid":{
"type":"string",
"description":"CodeList object identifier",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Code list definition including items or external mappings."
},
"imputationMethod":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Imputation method value",
"example":"MeanImputation"
},
"oid":{
"type":"string",
"description":"Imputation method object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Imputation method definition with value and identifier."
},
"presentation":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Presentation value",
"example":"Form Layout A"
},
"lang":{
"type":"string",
"description":"Language code",
"example":"en"
},
"oid":{
"type":"string",
"description":"Presentation object identifier",
"example":"a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29"
}
},
"description":"Presentation metadata including value, identifier and language."
},
"conditionDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Condition name",
"example":"AgeGreaterThan18"
},
"oid":{
"type":"string",
"description":"Condition object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Condition definition containing formal expressions and metadata."
},
"methodDef":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formalExpression":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Formal expression for validation",
"example":"@AGE > 18"
},
"context":{
"type":"string",
"description":"Context or language for expression",
"example":"XPath"
}
},
"description":"Formal expression used for validation."
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Method name",
"example":"DeriveBMI"
},
"type":{
"type":"string",
"description":"Method type",
"enum":[
"COMPUTATION",
"IMPUTATION",
"TRANSPOSE",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"Method object identifier",
"example":"86e83895-8674-443d-b2c9-f3a7ed25d119.2_0_0_39"
}
},
"description":"Method definition containing formal expressions and metadata."
},
"name":{
"type":"string",
"description":"Name of this study version",
"example":"Main Study MetaData v1"
},
"description":{
"type":"string",
"description":"Description of this study version",
"example":"Main Study Metadata for Diabetes Trial"
},
"oid":{
"type":"string",
"description":"Unique identifier for this MetaDataVersion",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"Represents the metadata about the study"
},
"OID":{
"type":"string",
"description":"Unique object identifier for the study, uppercase HEX UUID.",
"example":"D5E16DD550CB4AD1B330E0D09B4B8F3F"
}
},
"description":"ODM Study object"
},
"StudyDescription10":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Free-text description of the Study.",
"example":"Phase 3, double blind, randomized clinical study in Diabetes."
}
},
"description":"Free-text description of the ODM Study."
},
"StudyEventData1":{
"type":"object",
"properties":{
"auditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"signature":{
"$ref":"#/components/schemas/Signature1"
},
"annotation":{
"type":"array",
"description":"Annotations (queries, comments, flags) on this study event.",
"items":{
"$ref":"#/components/schemas/Annotation2"
}
},
"formData":{
"type":"array",
"description":"Forms captured within this study event.",
"items":{
"$ref":"#/components/schemas/FormData10"
}
},
"studyEventOID":{
"type":"string",
"description":"Identifier (OID) of the study event definition.",
"format":"oid",
"example":"SE.VISIT1"
},
"studyEventRepeatKey":{
"type":"string",
"description":"Repeat key when the same study event occurs multiple times.",
"example":"1"
},
"repeatingFormSummary":{
"$ref":"#/components/schemas/RepeatingFormSummary1"
},
"EventHistory":{
"type":"array",
"description":"History of actions performed on this study event.",
"example":[
{
"action":"Locked",
"actionDate":"2025-11-01T14:00:00Z"
}
],
"items":{
"$ref":"#/components/schemas/History1"
}
}
},
"description":"Subject visit or study event data block including forms, annotations and references."
},
"StudyEventDef1":{
"type":"object",
"properties":{
"description":{
"$ref":"#/components/schemas/Description10"
},
"formRef":{
"type":"object",
"properties":{
"formOID":{
"type":"string",
"description":"OID of the referenced form",
"example":"33caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
},
"orderNumber":{
"type":"integer",
"description":"Order of this form in the event",
"format":"int32",
"example":1
},
"mandatory":{
"type":"string",
"description":"Is this form mandatory in the event?",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception",
"example":"43caf3cb-1df6-4df5-a353-a337cbe6b50a.1_8_0_29"
}
},
"description":"FormRef metadata"
},
"alias":{
"type":"object",
"properties":{
"Context":{
"type":"string",
"description":"Locale, region, or terminology context.",
"example":"US"
},
"Name":{
"type":"string",
"description":"Alternative or alias name for the unit in this context.",
"example":"mg per deciliter"
}
},
"description":"A synonym, translation, or locale-specific label for a MeasurementUnit."
},
"name":{
"type":"string",
"description":"Event name",
"example":"Screening Event"
},
"repeating":{
"type":"string",
"description":"Whether this event may repeat",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"type":{
"type":"string",
"description":"Type of event",
"example":"SCHEDULED",
"enum":[
"Scheduled",
"Unscheduled",
"Common"
]
},
"category":{
"type":"string",
"description":"Event category",
"example":"Main"
},
"oid":{
"type":"string",
"description":"Unique identifier OID for the event",
"example":"SE1"
}
},
"description":"Study Event Def data"
},
"StudyEventRef1":{
"type":"object",
"properties":{
"orderNumber":{
"type":"integer",
"description":"Order of the event in schedule",
"format":"int32",
"example":1
},
"mandatory":{
"type":"string",
"description":"Is this event mandatory? YES or NO",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"collectionExceptionConditionOID":{
"type":"string",
"description":"OID for collection exception",
"example":"COND1"
},
"studyEventOID":{
"type":"string",
"description":"OID of the referenced study event",
"example":"SE1"
}
},
"description":"Study Event Ref data",
"example":[
{
"eventOID":"SE1"
}
]
},
"StudyName10":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Display name for the Study.",
"example":"Sample Study"
}
},
"description":"Human-readable display name for the ODM Study."
},
"SubjectData1":{
"type":"object",
"properties":{
"auditRecord":{
"$ref":"#/components/schemas/AuditRecord100"
},
"signature":{
"$ref":"#/components/schemas/Signature1"
},
"investigatorRef":{
"$ref":"#/components/schemas/InvestigatorRef1"
},
"siteRef":{
"$ref":"#/components/schemas/SiteRef10"
},
"annotation":{
"type":"array",
"description":"List of annotations (queries, notes, flags) linked to the subject data.",
"items":{
"$ref":"#/components/schemas/Annotation2"
}
},
"studyEventData":{
"type":"array",
"description":"All scheduled or unscheduled visit/event data for the subject.",
"items":{
"$ref":"#/components/schemas/StudyEventData1"
}
},
"subjectKey":{
"type":"string",
"description":"Unique key of the subject within the study/site.",
"format":"identifier",
"example":"SUBJ-0001"
},
"transactionType":{
"type":"string",
"description":"Operation represented by this payload, such as Insert, Update, or Delete.",
"example":"Update"
},
"initials":{
"type":"string",
"description":"Subject initials if captured.",
"example":"JD"
},
"transferData":{
"type":"array",
"description":"Data transfer records for this subject (e.g., imports or system migrations).",
"items":{
"$ref":"#/components/schemas/TransferData1"
}
},
"subjectHistory":{
"type":"array",
"description":"Chronological history of key actions for this subject.",
"items":{
"$ref":"#/components/schemas/History1"
}
}
},
"description":"ODM SubjectData structure including audit, signature, references and event data for a subject."
},
"Symbol10":{
"type":"object",
"properties":{
"TranslatedText":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Text value for this locale/language.",
"example":"gender"
},
"lang":{
"type":"string",
"description":"Language code for this translation, e.g. 'en'.",
"example":"null"
}
},
"description":"A localizable or translated representation of a symbol, label, or similar text element."
}
},
"description":"Symbol element for a MeasurementUnit."
},
"TransferData1":{
"type":"object",
"properties":{
"fromSiteName":{
"type":"string",
"description":"Name of the site the subject is transferred from",
"example":"Previous Site Name"
},
"toSiteName":{
"type":"string",
"description":"Name of the site the subject is transferred to",
"example":"New Site Name"
},
"transferDate":{
"type":"string",
"description":"Date when the subject transfer occurred",
"example":"2023-12-31"
}
},
"description":"Subject transfer details between sites"
},
"TransformType2":{
"type":"object",
"properties":{
"content":{
"type":"object",
"description":"Optional content/parameters for the Transform."
},
"algorithm":{
"type":"string",
"description":"Transform algorithm URI.",
"example":"http://www.w3.org/2000/09/xmldsig#enveloped-signature"
}
},
"description":"Transform algorithm definition and optional parameters applied to referenced data."
},
"TransformsType1":{
"type":"object",
"properties":{
"transform":{
"type":"object",
"properties":{
"content":{
"type":"object",
"description":"Optional content/parameters for the Transform."
},
"algorithm":{
"type":"string",
"description":"Transform algorithm URI.",
"example":"http://www.w3.org/2000/09/xmldsig#enveloped-signature"
}
},
"description":"Transform algorithm definition and optional parameters applied to referenced data."
}
},
"description":"Collection of Transform elements applied to the referenced data."
},
"TranslatedText1":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Text value for this locale/language.",
"example":"gender"
},
"lang":{
"type":"string",
"description":"Language code for this translation, e.g. 'en'.",
"example":"null"
}
},
"description":"A localizable or translated representation of a symbol, label, or similar text element."
},
"User100":{
"type":"object",
"properties":{
"loginName":{
"$ref":"#/components/schemas/LoginName1"
},
"displayName":{
"$ref":"#/components/schemas/DisplayName1"
},
"fullName":{
"$ref":"#/components/schemas/FullName10"
},
"firstName":{
"$ref":"#/components/schemas/FirstName10"
},
"lastName":{
"$ref":"#/components/schemas/LastName10"
},
"organization":{
"$ref":"#/components/schemas/Organization10"
},
"address":{
"type":"object",
"properties":{
"streetName":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Street name line.",
"example":"123 Main Street"
}
},
"description":"Street name component of a postal address."
},
"city":{
"$ref":"#/components/schemas/City1"
},
"stateProv":{
"$ref":"#/components/schemas/StateProv1"
},
"country":{
"$ref":"#/components/schemas/Country1"
},
"postalCode":{
"$ref":"#/components/schemas/PostalCode1"
},
"otherText":{
"$ref":"#/components/schemas/OtherText1"
}
},
"description":"Postal or location address for an ODM user or site, with support for street, city, state, country, and postal code."
},
"email":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Email address.",
"example":"john.smith@email.com"
}
},
"description":"Email address record for an ODM user."
},
"picture":{
"$ref":"#/components/schemas/Picture1"
},
"pager":{
"$ref":"#/components/schemas/Pager1"
},
"fax":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Fax number.",
"example":"555-5678"
}
},
"description":"Fax number/contact for an ODM User."
},
"phone":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Phone number.",
"example":"555-9876"
}
},
"description":"Phone number/contact entry for ODM User."
},
"locationRef":{
"type":"object",
"properties":{
"LocationOID":{
"type":"string",
"description":"OID/ID for the associated location.",
"example":"475454D6B7F247C88D401DB25CA2C7D2"
}
},
"description":"Reference to a study/site location for an ODM User."
},
"certificate":{
"type":"object",
"properties":{
"Value":{
"type":"string",
"description":"Certificate/credential identifier.",
"example":"CERT123"
}
},
"description":"Digital certificate or identity for an ODM User."
},
"userType":{
"type":"string",
"description":"Enumeration of possible user types/roles for ODM User.",
"enum":[
"SPONSOR",
"INVESTIGATOR",
"LAB",
"OTHER"
]
},
"oid":{
"type":"string",
"description":"User OID value ",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Represents a user in the ODM AdminData structure (site personnel, investigator, etc)."
},
"UserRef10":{
"type":"object",
"properties":{
"UserOID":{
"type":"string",
"description":"OID of the referenced user",
"format":"oid",
"example":"c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29"
}
},
"description":"Reference to a user within the study."
},
"SubjectEventInfoDto":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Event associated with the Subject. The acceptable values are - SubjectNumberReplaced, SubjectNumberChanged, Enrolled, New, Randomized, Complete, Undo_Withdrawn, Screened, Transferred, Screen_Failed, Visit_Complete, VisitDispensed, VisitRandomized and VisitScreened ",
"example":"SubjectNumberReplaced"
},
"subjects":{
"type":"array",
"description":"List of subject identifiers associated with the event",
"example":[
"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"93CC828113AC439181071CB44D2C6FE5"
],
"items":{
"type":"string",
"description":"List of subject identifiers associated with the event",
"format":"uuid"
}
}
},
"description":"Event summary including the event identifier and the list of associated subject identifiers."
},
"SubjectEventsInfoDto":{
"type":"object",
"properties":{
"tenant":{
"type":"string",
"description":"Tenant identifier",
"example":"TENANT-A"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"mode":{
"type":"string",
"description":"Indicates the operational mode of the study. Accepted values: active, test, or training.",
"example":"active"
},
"events":{
"type":"array",
"description":"List of event entries including event id and associated subjects",
"items":{
"$ref":"#/components/schemas/SubjectEventInfoDto"
}
}
},
"description":"Container for subject event details within a study and mode, including a list of event entries per subject."
},
"SubjectNumberDto":{
"required":[
"state",
"subjectNumber"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Subject unique identifier (UUID, 32-character uppercase hexadecimal string)",
"example":"A1B2C3D4E5F60718273645AABBCCDDEE"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0002"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"objectVersionNumber":{
"type":"integer",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":3
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Subject number mapping with state, ID, site, version and study linkage."
},
"SubjectSDVDto":{
"required":[
"subjectNumber"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier for the SDV subject (UUID, 32-character uppercase hexadecimal string)",
"example":"22223333444455556666777788889999"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0204"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"FEDCBA1234567890FEDCBA1234567890"
},
"sdvSelectionStatus":{
"type":"string",
"description":"Source data verification selection status for the subject it can be NOT_SELECTED, INITIALCOUNT_SELECTED, POST_INITIALCOUNT_SELECTED.",
"example":"NOT_SELECTED"
}
},
"description":"Basic SDV subject selection information."
},
"SubjectSDVDtoList":{
"type":"object",
"properties":{
"prevSelectedSubjectNumber":{
"type":"string",
"description":"Previously selected subject number for reference.",
"example":"SUBJ-0001"
},
"subjectsList":{
"type":"array",
"description":"List of SDV subject objects returned as selection status result.",
"items":{
"$ref":"#/components/schemas/SubjectSDVDto"
}
}
},
"description":"List of SDV subject selection objects with the previously selected subject number."
},
"SubjectsVisitScheduleRequest":{
"type":"object",
"properties":{
"sites":{
"type":"array",
"description":"List of site identifiers to scope the search",
"example":[
"D3C9A4B5E6F78123456789ABCDEF1234",
"E1F2A3B4C5D6E7F89012ABCDEF345678"
],
"items":{
"type":"string",
"description":"List of site identifiers to scope the search",
"format":"uuid"
}
},
"limit":{
"type":"integer",
"description":"Maximum number of results to return",
"format":"int32",
"example":25
},
"offset":{
"type":"integer",
"description":"Offset for pagination",
"format":"int32",
"example":0
},
"order":{
"type":"string",
"description":"Sort order for results",
"example":"asc"
},
"reviewStatus":{
"type":"string",
"description":"Review status filter applied to subjects. Values can be noopenqueries, openqueries, verified, signed, locked, allvisitscomplete, readytosign, allvisitscomplete, readytoverify, all, signedandverified, frozen ",
"example":"all"
},
"subjectStates":{
"type":"array",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed",
"example":[
"Auto_Screen_Failed"
],
"items":{
"type":"string",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed",
"example":"[\"Auto_Screen_Failed\"]"
}
},
"exactSearchKeywords":{
"type":"array",
"description":"Keywords for exact match in subject search which will be applied on subject number",
"example":[
"1001",
"SMITH"
],
"items":{
"type":"string",
"description":"Keywords for exact match in subject search which will be applied on subject number",
"example":"[\"1001\",\"SMITH\"]"
}
},
"containsSearchKeywords":{
"type":"array",
"description":"Keywords for contains match in subject search which will be applied on subject number",
"example":[
"100",
"SMI"
],
"items":{
"type":"string",
"description":"Keywords for contains match in subject search which will be applied on subject number",
"example":"[\"100\",\"SMI\"]"
}
},
"nextVisitOnly":{
"type":"boolean",
"description":"When true, only the next scheduled visit is returned per subject",
"example":false
},
"notStarted":{
"type":"boolean",
"description":"When true, include only subjects that have not started",
"example":false
}
},
"description":"Request payload to retrieve visit schedules for subjects filtered by sites, pagination, ordering, review status and state filters"
},
"DispensationKit":{
"title":"DispensationKit v13.0",
"type":"object",
"properties":{
"id":{
"title":"Dispensation Kit ID",
"type":"number",
"description":"Unique identifier of the dispensation kit.",
"format":"Integer",
"example":2
},
"kitDescription":{
"title":"Kit Description",
"type":"string",
"description":"Kit description.",
"example":"Kit A"
},
"dose":{
"title":"Dose",
"type":"number",
"description":"Dose.",
"format":"double",
"example":5
},
"measurement":{
"title":"Measurement",
"type":"string",
"description":"Dose Measurement.",
"example":"ml"
},
"frequency":{
"title":"Frequency",
"type":"string",
"description":"Dosing frequency.",
"example":"BID",
"enum":[
"Once",
"QD",
"BID",
"TID",
"QID",
"Q3",
"Q4",
"Q8",
"Q12",
"Q24",
"Bedtime",
"With meals",
"With meals and at bedtime"
]
},
"consumeAcrossDoses":{
"title":"Consume Across Doses",
"type":"boolean",
"description":"Indicates whether consumption across doses is allowed.",
"example":true
},
"deviceType":{
"title":"Device Type",
"type":"string",
"description":"Device type.",
"example":"ActivityWatch",
"enum":[
"ActivityWatch",
"BloodPressureMonitor",
"WeightScale",
"ECGReader",
"Spirometer",
"MobileApp",
"SmartPillBottle",
"PulseOximeter",
"WearablePatch",
"Other",
"GlucoseMonitor"
]
},
"deviceConnection":{
"title":"Device Connection Type",
"type":"string",
"description":"Device connection type.",
"example":"DevicetoCloud",
"enum":[
"CloudtoCloud",
"DevicetoCloud",
"NoConnection"
]
},
"inventoryId":{
"title":"Inventory ID",
"type":"string",
"description":"Inventory ID.",
"example":"D313327EF13845169A8ADADDA435431E"
},
"trialSupplyType":{
"title":"Trial Supply Type",
"type":"string",
"description":"Type of the trial supply.",
"example":"BOTTLE"
},
"conserved":{
"title":"Conserved",
"type":"boolean",
"description":"Conserved for dispensation.",
"example":true
},
"titrationKitLabel":{
"title":"Blinded Titration Label",
"type":"string",
"description":"Blinded titration label.",
"example":"High dose"
},
"barcode":{
"type":"string",
"description":"Barcode.",
"example":"1000"
},
"dispensationConfirmed":{
"type":"boolean",
"description":"Indicates whether dispensation is confirmed.",
"example":true
},
"groupingNumber":{
"title":"Grouping Number",
"type":"integer",
"description":"Grouping number for a kit.",
"format":"int32",
"example":1
},
"kitNumberUTF":{
"title":"Kit Number UTF",
"type":"string",
"description":"Kit number with UTF-8 support.",
"example":"A-1"
},
"dosingUnblinded":{
"title":"Dosing Unblinded",
"type":"boolean",
"description":"Indicates whether dosing is unblinded.",
"example":true
},
"titrationOption":{
"title":"Titration Option",
"type":"string",
"description":"Titration options to dispense kits. For example: up/down/maintain.",
"example":"up",
"enum":[
"up",
"down",
"maintain"
]
},
"locallySourced":{
"title":"Locally Sourced",
"type":"boolean",
"description":"Indicates whether the kit is locally sourced.",
"example":true
},
"quantity":{
"title":"Quantity",
"type":"number",
"description":"Kit quantity.",
"format":"BigDecimal",
"example":5
},
"lotId":{
"title":"Lot ID",
"type":"string",
"description":"Lot ID.",
"example":"D313327EF13845169A8ADADDA435431E"
},
"lotNumber":{
"title":"Lot Number",
"type":"string",
"description":"Lot number.",
"example":"LOT20240605A"
},
"dosingInstruction":{
"title":"Dosing Instruction",
"type":"string",
"description":"Dosing instruction.",
"example":"Take one capsule daily"
}
},
"description":"Contains information for the kit dispensation."
},
"VisitResultV11":{
"title":"VisitResult v11.0",
"type":"object",
"properties":{
"randomNumber":{
"title":"Random Number",
"type":"string",
"description":"Random number.",
"example":"10"
},
"kits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationKit"
}
},
"visitTimestamp":{
"title":"Visit Timestamp",
"type":"string",
"description":"Visit timestamp.",
"format":"date-time"
},
"treatmentTitle":{
"title":"Treatment Title",
"type":"string",
"description":"Treatment title.",
"example":"A"
},
"needsToVisitPharmacist":{
"title":"Needs To Visit Pharmacist",
"type":"boolean",
"description":"Indicates whether the subject needs to visit an unblinded pharmacist for kit dispensation.",
"example":true
},
"countOfKitTypesOnDoseHold":{
"title":"Count Of Kit Types On Dose Hold",
"type":"integer",
"description":"Number of kit types on dose hold.",
"format":"int32",
"example":1
}
},
"description":"Visit result."
},
"DoseHoldRequestV2":{
"title":"Dose Hold Request",
"type":"object",
"properties":{
"isUnblindedPharmacist":{
"title":"Treatment Assignment Visibility",
"type":"boolean",
"description":"Indicates whether treatment assignment information may be visible to study personnel. It should not be visible to study personnel and must be accessible only to an unblinded pharmacist.",
"example":true
},
"kitTypeSrcId":{
"title":"Kit Type Source ID",
"type":"string",
"description":"Kit type ID.",
"format":"uuid"
},
"trialSupplyType":{
"title":"Trial Supply Type",
"type":"string",
"description":"Type of the trial supply.",
"example":"BOTTLE"
},
"deviceType":{
"title":"Device Type",
"type":"string",
"description":"Device type.",
"example":"Spirometer"
},
"isTitration":{
"title":"Titration",
"type":"boolean",
"description":"Indicates whether the current medication is a titration.",
"example":true
}
},
"description":"Request containing dose hold settings."
},
"Parameter":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"uuid"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"uuid"
},
"value":{
"type":"string",
"description":"Value of the item",
"format":"uuid"
}
},
"description":"Contains details about parameters of the form"
},
"SubjectDto12":{
"title":"DCS Subject",
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Subject properties indicating completion capability and the locked study version"
},
"VisitRequest":{
"title":"Visit Request",
"required":[
"siteId",
"studyVersion",
"subjectId",
"visitId"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"uuid"
},
"visitId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"format":"uuid"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.5"
},
"visitTimestamp":{
"pattern":"(\\d){4}-(\\d){2}-(\\d){2} (\\d){2}:(\\d){2}:(\\d){2}",
"type":"string",
"description":"Visit date and time",
"example":"2018-11-23 08:43:01"
},
"AuthUserListDtoV1":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Parameter"
}
},
"reusableKits":{
"title":"Reusable Kits",
"uniqueItems":true,
"type":"array",
"description":"IDs of kits that can be reused in the visit.",
"items":{
"type":"string",
"format":"uuid"
}
},
"notifyDispensationFailureOnly":{
"type":"string"
},
"notifyRandomizationFailureOnly":{
"type":"string"
},
"titrationOption":{
"title":"Titration Option",
"pattern":"up|down|maintain",
"type":"string",
"description":"Titration options to dispense kits. For example: up/down/maintain.",
"example":"up",
"enum":[
"up",
"down",
"maintain"
]
},
"userConfirmationTaken":{
"title":"User Confirmation Taken",
"type":"boolean",
"description":"User confirmation for titration.",
"example":true
},
"instanceNumber":{
"title":"Instance Number",
"minimum":1,
"type":"number",
"description":"Visit instance number.",
"format":"BigDecimal",
"example":2
},
"kitTypesForDoseHold":{
"title":"Kit Types for Dose Hold",
"type":"array",
"description":"List of kit types configured for dose hold.",
"items":{
"$ref":"#/components/schemas/DoseHoldRequestV2"
}
},
"kitTypesForResumeDispensation":{
"title":"Kit Types for Resume Dispensation",
"type":"array",
"description":"List of kit types for which to resume dispensation.",
"items":{
"$ref":"#/components/schemas/DoseHoldRequestV2"
}
},
"resumePartialDispensation":{
"title":"Resume Partial Dispensation",
"type":"boolean",
"description":"Indicates whether to resume partial dispensation in the visit.",
"example":false
},
"notify_dispensation_failure_only":{
"title":"Notify Dispensation Failure Only",
"type":"string",
"description":"Send notification only for dispensation failures.",
"example":"true"
},
"notify_randomization_failure_only":{
"title":"Notify Randomization Failure Only",
"type":"string",
"description":"Send notification only for randomization failures.",
"example":"true"
},
"isVisitWithinWindow":{
"title":"Visit Within Window",
"type":"boolean",
"description":"Indicates whether the visit occurs within the configured window.",
"example":true
},
"visits":{
"title":"Visits",
"type":"array",
"description":"Visit status details.",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto9"
}
},
"dcssubjects":{
"$ref":"#/components/schemas/SubjectDto12"
},
"blind_rand_number_enabled":{
"title":"Blind Rand Number Enabled",
"type":"string",
"description":"Check if rand number needs to be blinded",
"example":"true"
},
"forcedRandLimitReached":{
"title":"forcedRandLimitReached",
"type":"boolean",
"description":"Check if forced limit is reached",
"example":true
}
},
"description":"Request containing subject visit details."
},
"VisitsStatusDto9":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
}
},
"description":"Visit status details including associated study version"
},
"MhealthSubjectDto":{
"type":"object",
"properties":{
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
}
},
"description":"DTO representing subject registration in mHealth context."
},
"SubjectDto4":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Subject details extended with mHealth subject identifier"
},
"RevertSubjectRequest":{
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"The reason for reverting or deleting the subject (max 255 chars)",
"example":"Duplicate entry detected"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments or context for the operation (max 2048 chars)",
"example":"Subject was mistakenly created twice and needs removal"
}
},
"description":"Request payload to revert/delete a subject, providing justification and details for auditing"
},
"SubjectDto_3":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Subject details including object version number for optimistic locking"
},
"SubjectNumberRequestDto":{
"required":[
"objectVersionNumber",
"reason",
"subjectNumber"
],
"type":"object",
"properties":{
"objectVersionNumber":{
"type":"integer",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":5
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0111"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for updating the subject number (max 255 chars)",
"example":"Subject number update required"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments for auditing",
"example":"Correction due to site transfer"
}
},
"description":"Request payload to update a subject number, specifying the new number with reason and comment."
},
"DcsResponseSubjectDto1":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectDto1"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectNumbersDto_V1":{
"required":[
"newSubjectNumber",
"objectVersionNumber"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"3BF8356C6E4B49678D0609FF244DB4E3"
},
"newSubjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUB-10"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":5
}
},
"description":"Subject details for subject number changes."
},
"SubjectNumbersRequestDto":{
"required":[
"reason",
"subjects"
],
"type":"object",
"properties":{
"subjects":{
"$ref":"#/components/schemas/SubjectNumbersDto_V1"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Others",
"example":"Wrong data entered."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Reason for change in subject number",
"example":"Wrong data entered."
}
},
"description":"Payload for bulk updating subject numbers in batch."
},
"SubjectDto8":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Subject details including any previous subject number reference"
},
"SubjectNumbersResponseV1":{
"title":"SubjectNumbersResponse v1.0",
"type":"object",
"properties":{
"subjects":{
"$ref":"#/components/schemas/SubjectDto8"
}
},
"description":"Response payload for bulk subject number updates, listing updated subject details (including previous subject number if available)."
},
"DcsResponseSubjectNumbersResponseV1":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectNumbersResponseV1"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectRespDto15":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"canBeReplaced":{
"type":"boolean",
"description":"Indicates if the subject can be replaced",
"example":true
},
"canBeUndoWithdrawn":{
"type":"boolean",
"description":"Indicates if a withdrawn subject can be undone",
"example":true
},
"reScreenEventInstanceNum":{
"type":"integer",
"description":"Event instance number for the re-screen event if present",
"format":"int32",
"example":2
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Screening number assigned to the subject",
"example":"SCR-0001"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-001"
},
"withdrawalReason":{
"type":"string",
"description":"Reason provided when the subject is withdrawn",
"example":"Not applicable"
},
"ehrLinkStatus":{
"type":"number",
"description":"EHR link status code for the subject",
"example":1
},
"withdrawalDate":{
"type":"string",
"description":"Date when the subject was withdrawn",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date when the subject completed the study",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"withdrawalComment":{
"type":"string",
"description":"Additional comment provided for withdrawal",
"example":"Subject breached protocols"
},
"screenFailureComment":{
"type":"string",
"description":"Additional comment for screen failure",
"example":"Subject breached protocols"
},
"replaceRand":{
"type":"string",
"description":"Replacement randomization identifier if applicable",
"example":"Y"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries for the subject",
"format":"int32",
"example":2
},
"incompleteVisits":{
"type":"integer",
"description":"Number of incomplete visits for the subject",
"format":"int32",
"example":1
}
},
"description":"Subject response details including re-screening event instance number and all inherited subject properties"
},
"DcsResponseListSubjectRespDto15":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectRespDto15"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectRespDto16":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"canBeReplaced":{
"type":"boolean",
"description":"Indicates if the subject can be replaced",
"example":true
},
"canBeUndoWithdrawn":{
"type":"boolean",
"description":"Indicates if a withdrawn subject can be undone",
"example":true
},
"reScreenEventInstanceNum":{
"type":"integer",
"description":"Event instance number for the re-screen event if present",
"format":"int32",
"example":2
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Screening number assigned to the subject",
"example":"SCR-0001"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-001"
},
"withdrawalReason":{
"type":"string",
"description":"Reason provided when the subject is withdrawn",
"example":"Not applicable"
},
"ehrLinkStatus":{
"type":"number",
"description":"EHR link status code for the subject",
"example":1
},
"withdrawalDate":{
"type":"string",
"description":"Date when the subject was withdrawn",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date when the subject completed the study",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"withdrawalComment":{
"type":"string",
"description":"Additional comment provided for withdrawal",
"example":"Subject breached protocols"
},
"screenFailureComment":{
"type":"string",
"description":"Additional comment for screen failure",
"example":"Subject breached protocols"
},
"replaceRand":{
"type":"string",
"description":"Replacement randomization identifier if applicable",
"example":"Y"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries for the subject",
"format":"int32",
"example":2
},
"incompleteVisits":{
"type":"integer",
"description":"Number of incomplete visits for the subject",
"format":"int32",
"example":1
},
"enrollmentDate":{
"type":"string",
"description":"Date the subject was enrolled",
"format":"date"
}
},
"description":"Subject response details including enrollment date and all inherited subject properties"
},
"DcsResponseListSubjectRespDto16":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectRespDto16"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectCountResponseDto":{
"type":"object",
"properties":{
"totalSubjects":{
"type":"integer",
"description":"Total number of subjects",
"format":"int32",
"example":200
},
"newSubjects":{
"type":"integer",
"description":"Number of newly added subjects",
"format":"int32",
"example":12
},
"activeSubjects":{
"type":"integer",
"description":"Number of currently active subjects",
"format":"int32",
"example":160
},
"withdrwanSubjects":{
"type":"integer",
"description":"Number of subjects withdrawn from the study",
"format":"int32",
"example":5
},
"enrolledSubjects":{
"type":"integer",
"description":"Number of subjects who have been enrolled",
"format":"int32",
"example":89
},
"screendSubjects":{
"type":"integer",
"description":"Number of subjects who have been screened",
"format":"int32",
"example":180
},
"screenFailedSubjects":{
"type":"integer",
"description":"Number of subjects who failed screening",
"format":"int32",
"example":4
},
"completedSubjects":{
"type":"integer",
"description":"Number of subjects who completed the study",
"format":"int32",
"example":23
}
},
"description":"Aggregate subject counts summary (total, active, withdrawn, enrolled, screened, failed, completed, new)"
},
"SubectNextVisitActionResultDto":{
"type":"object",
"properties":{
"nextVisitAction":{
"type":"integer",
"description":"Next Visit Action will happen. Its values can be SCREEN_ENABLE, SCREEN_DISABLE, RANDOMIZE_ENABLE, RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE",
"format":"int32"
}
}
},
"DcsResponseSubectNextVisitActionResultDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubectNextVisitActionResultDto"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectScreeningNumberResponseDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":" unique identifier (UUID, 32-character uppercase hexadecimal string) for a subject ",
"example":"9876543210ABCDEF1234567890ABCDEF"
},
"screeningNumber":{
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SCR-00123"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"objectVersionNumber":{
"type":"integer",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":3
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Organization ID (UUID, 32-character uppercase hexadecimal string) for subject number at site",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
}
},
"description":"Subject screening number and related site details"
},
"ResupplySubjectsListDto":{
"type":"object",
"properties":{
"siteResupplySubjectsList":{
"type":"array",
"description":"Collection of per-site resupply subject lists",
"items":{
"$ref":"#/components/schemas/SiteResupplySubjectsListDto"
}
}
},
"description":"Aggregated subjects per site for resupply evaluation based on visit windows and skip rules"
},
"SiteResupplySubjectsListDto":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"screenedSubjects":{
"type":"array",
"description":"Subject Identifiers (UUID, 32-character uppercase hexadecimal string) that are screened at the site",
"example":[
"A3F1C4B2D8E947F0A1B2C3D4E5F6A7B8",
"9F8E7D6C5B4A3A2B1C0D9E8F7A6B5C4D"
],
"items":{
"type":"string",
"description":"Subject Identifiers (UUID, 32-character uppercase hexadecimal string) that are screened at the site",
"format":"uuid"
}
},
"randomizedSubjects":{
"type":"array",
"description":"Subject Identifiers (UUID, 32-character uppercase hexadecimal string) that are randomized at the site",
"example":[
"3C1D5E7F9A0B2C4D6E8F0A1B2C3D4E5F",
"ABCDEF1234567890ABCDEF1234567890"
],
"items":{
"type":"string",
"description":"Subject Identifiers (UUID, 32-character uppercase hexadecimal string) that are randomized at the site",
"format":"uuid"
}
}
},
"description":"Subjects per site categorized by screening and randomization status for resupply processing"
},
"VisitsStatusDto12":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Locked status for the visit start date.Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Visit status details including lock status and lock timestamps"
},
"SubjectRespDto13":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Screening number assigned to the subject",
"example":"SCR-0001"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-001"
},
"withdrawalReason":{
"type":"string",
"description":"Reason provided when the subject is withdrawn",
"example":"Not applicable"
},
"ehrLinkStatus":{
"type":"number",
"description":"EHR link status code for the subject",
"example":1
},
"withdrawalDate":{
"type":"string",
"description":"Date when the subject was withdrawn",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date when the subject completed the study",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"withdrawalComment":{
"type":"string",
"description":"Additional comment provided for withdrawal",
"example":"Subject breached protocols"
},
"screenFailureComment":{
"type":"string",
"description":"Additional comment for screen failure",
"example":"Subject breached protocols"
}
},
"description":"Subject details including screening, randomization, completion status and withdrawal information"
},
"SubjectRespDto14":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"canBeReplaced":{
"type":"boolean",
"description":"Indicates if the subject can be replaced",
"example":true
},
"canBeUndoWithdrawn":{
"type":"boolean",
"description":"Indicates if a withdrawn subject can be undone",
"example":true
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Screening number assigned to the subject",
"example":"SCR-0001"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-001"
},
"withdrawalReason":{
"type":"string",
"description":"Reason provided when the subject is withdrawn",
"example":"Not applicable"
},
"ehrLinkStatus":{
"type":"number",
"description":"EHR link status code for the subject",
"example":1
},
"withdrawalDate":{
"type":"string",
"description":"Date when the subject was withdrawn",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date when the subject completed the study",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"withdrawalComment":{
"type":"string",
"description":"Additional comment provided for withdrawal",
"example":"Subject breached protocols"
},
"screenFailureComment":{
"type":"string",
"description":"Additional comment for screen failure",
"example":"Subject breached protocols"
},
"replaceRand":{
"type":"string",
"description":"Replacement randomization identifier if applicable",
"example":"Y"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries for the subject",
"format":"int32",
"example":2
},
"incompleteVisits":{
"type":"integer",
"description":"Number of incomplete visits for the subject",
"format":"int32",
"example":1
}
},
"description":"Subject response details including fields like replacement randomization, unresolved queries etc.."
},
"Subject1":{
"required":[
"state",
"subjectNumber"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Subject unique identifier (UUID, 32-character uppercase hexadecimal string) .",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Description of the subject record.",
"example":"Screened subject record"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0199"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"BEEFAABBCCDDEEDDFF00112233445566"
},
"dob":{
"type":"string",
"description":"Date of birth of the subject.",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Screened"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the 'state' was updated.",
"format":"date-time",
"example":"2025-10-01T09:00:01Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for subject screen failure, if applicable.",
"example":"Lost to follow up"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure (if the subject is not enrolled).",
"example":"Consent Required"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Administrative override details for subject enrollment, if any.",
"example":"Subject enrollment overidden"
},
"informedConsentDate":{
"type":"string",
"description":"Date the subject provided informed consent.",
"format":"date-time"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Subject gender: typically 'male', 'female', or 'other'.",
"example":"male"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"format":"uuid"
},
"fromStudyId":{
"type":"string",
"description":"Originating study id for transferred subjects UUID, 32-character uppercase hexadecimal string.",
"format":"uuid"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Organization/site identifier for subject number context.",
"example":"AABBCC11223344556677"
},
"sdvSelectionStatus":{
"type":"string",
"description":"Source data verification selection status for the subject it can be NOT_SELECTED, INITIALCOUNT_SELECTED, POST_INITIALCOUNT_SELECTED.",
"example":"NOT_SELECTED"
},
"withdrawalDate":{
"type":"string",
"description":"Date the subject was withdrawn from the study.",
"format":"date-time",
"example":"2025-10-01T09:00:01Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date the subject completed the study.",
"format":"date-time",
"example":"2025-10-01T09:00:01Z"
},
"unblindDate":{
"type":"string",
"description":"Date/time the subject was unblinded.",
"format":"date-time",
"example":"2025-10-01T09:00:01Z"
},
"unblindReason":{
"type":"string",
"description":"Reason for subject being unblinded.",
"example":"Reason"
},
"unblindComment":{
"type":"string",
"description":"Further comment on unblinding.",
"example":"required comment"
},
"withdrawalReason":{
"type":"string",
"description":"Reason for withdrawal.",
"example":"reason for withdrawal"
},
"withdrawalComment":{
"type":"string",
"description":"Comment on withdrawal.",
"example":"comment for withdrawal"
},
"screenFailureComment":{
"type":"string",
"description":"Extended comment about screen failure.",
"example":"comment for screen failure"
},
"replaceRand":{
"type":"string",
"description":"Indicates if subject's randomization was replaced (Y/N).",
"example":"Y"
},
"enrollmentDate":{
"type":"string",
"description":"Date the subject was enrolled.",
"format":"date-time",
"example":"2025-10-01T09:00:01Z"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject can be completed (UI-only transient flag).",
"example":true
},
"canBeReplaced":{
"type":"boolean",
"description":"Indicates if the subject randomization can be replaced (UI-only transient flag).",
"example":false
},
"canBeUndoWithdrawn":{
"type":"boolean",
"description":"Indicates if the subject's withdrawal can be undone (UI-only transient flag).",
"example":true
},
"reScreenEventInstanceNum":{
"type":"number",
"description":"Number of times the subject was re-screened (transient, computed on the fly).",
"example":2
},
"totalAllowedRescreenLimit":{
"type":"string",
"description":"The maximum number of rescreens allowed for the subject (transient, calculated).",
"example":"3"
},
"previousSubjectNumber":{
"type":"string",
"description":"The previous subject number, for audit/tracking purposes (if the subject number changed).",
"example":"SUBJ-0177"
},
"subjectSDVUpdated":{
"type":"boolean",
"description":"Indicates if the subject's Source Data Verification has been updated.",
"example":true
},
"randomizationNumber":{
"type":"string",
"description":"The randomization number assigned to the subject.",
"example":"RAND-00235"
},
"screenFailureDate":{
"type":"string",
"description":"The date the subject failed screening, if applicable.",
"format":"date-time"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"The timestamp or user who last signed the subject data, if transiently tracked.",
"example":"2025-10-15T08:00:00.000Z"
},
"lockedStatus":{
"type":"string",
"description":"Current locked status of the subject record from UI perspective.Values can be LOCKED, NEVER_LOCAKED, UNLOCKED, NOT_APPLICABLE",
"example":"LOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates if any data is locked for this subject (boolean, transient).",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"When this subject was locked, if at all (ISO date-time string).",
"format":"date-time",
"example":"2025-10-18T11:05:00Z"
},
"lockedInStudyVersion":{
"type":"string",
"description":"The study version string when the subject was locked.",
"example":"1.0.0.0"
}
},
"description":"Comprehensive subject details including identity, site, study, demographic and state details, with example showing all fields."
},
"SubjectScreenCandidateResponseDto":{
"required":[
"dataElements",
"subject"
],
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/Subject1"
},
"visit":{
"$ref":"#/components/schemas/VisitsStatus"
},
"dataElements":{
"type":"array",
"description":"All data elements extracted from the screen form for the subject.",
"items":{
"$ref":"#/components/schemas/DataElement"
}
}
},
"description":"Screen subject candidate response object: details of the subject, visit status, and data elements captured."
},
"VisitsStatus":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for visit status.",
"example":"AABBCCDDEEFF00112233445566778899"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AABBCCDDEEFF00112233445566778899"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D1AABBCCDDEEFF112233445566778899"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"BEEFAABBCCDDEEDDFF00112233445566"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.1.0.2"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETED"
},
"visitStartDate":{
"type":"string",
"description":"Date/time the visit was started.",
"format":"date-time",
"example":"2025-10-02T08:45:00Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"associatedStudyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Associated study version, if visit is linked to another protocol version.",
"example":"3.1.0.2"
},
"display":{
"type":"string",
"description":"Display indicator flag (Y/N), whether this visit should display in UIs.",
"example":"Y"
},
"leadingDataelementId":{
"type":"string",
"description":"Unique Identfier ( (UUID, 32-character uppercase hexadecimal string) of the leading data element for this visit, if any.",
"example":"EEDD00112233445566778899AABBCCDD"
},
"dynamicAllCycles":{
"type":"string",
"description":"Indicates if visit is part of dynamic all cycles (Y/N).",
"example":"N"
},
"visitWindowWarning":{
"type":"string",
"description":"Window warning details or messages for visit timing.",
"example":"Visit outside of permitted window."
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date (dynamic calculation for visit scheduling).",
"format":"date-time",
"example":"2025-09-30T00:00:00Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit (dynamic calculation).",
"format":"date-time",
"example":"2025-10-05T23:59:59Z"
},
"scheduledDate":{
"type":"string",
"description":"holds visit schedule date which is calculated from an anchor visit start date.",
"format":"date-time",
"example":"2025-10-02T09:00:00Z"
},
"scheduledStartDate":{
"type":"string",
"description":"holds visit schedule start date which is calculated from the visit scheduledDate.",
"format":"date-time",
"example":"2025-10-02T00:00:00Z"
},
"scheduledEndDate":{
"type":"string",
"description":"holds visit schedule end date which is calculated from the visit scheduledDate.",
"format":"date-time",
"example":"2025-10-03T23:59:59Z"
},
"scheduledFromEventGUID":{
"type":"string",
"description":"Event ID (UUID, 32-character uppercase hexadecimal string) from which the schedule for this visit was derived.",
"example":"EEDD00112233445566778899AABBCCDD"
},
"repeatingFormCount":{
"type":"number",
"description":"Count of repeating forms related to visit.",
"example":0
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"lockedStatus":{
"type":"string",
"description":"Lock status specifically for the visit start date.Values can be LOCKED, UNLOCKED, NEVER_LOCKED, NOT_APPLICABLE",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Date/time when the visit was locked (if applicable).",
"format":"date-time",
"example":"2025-10-02T12:00:00Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Datetime when visit start date was locked.",
"format":"date-time",
"example":"2025-10-02T12:00:00Z"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"Freezed"
},
"doseHoldAction":{
"type":"string",
"description":"Holds any dose hold action taken on this visit.",
"example":"ENABLE"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"ENABLE"
},
"designStudyVersion":{
"type":"string",
"description":"Design version for the study when visit was enerated.",
"example":"3.1.0.2"
},
"visitStartDateFreezeStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"visitStartDateVerifyStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFY"
},
"visitStartDateSignStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
}
},
"description":"Details of the visit for screening."
},
"ExecuteRuleTO":{
"title":"Rule Execution Result",
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Execution status for the rule.",
"example":"Success"
},
"message":{
"type":"string",
"description":"Detailed message describing the outcome or error.",
"example":"Rule executed successfully."
}
},
"description":"Represents the outcome of executing a single rule."
},
"RuleMemoryRespTO":{
"type":"object",
"properties":{
"ruleResults":{
"type":"array",
"description":"Outcomes for each executed rule.",
"items":{
"$ref":"#/components/schemas/ExecuteRuleTO"
}
},
"ruleTargets":{
"type":"array",
"description":"Targets affected by rule execution with optional value or validation changes.",
"items":{
"$ref":"#/components/schemas/RuleMemoryRespTargetTO"
}
}
},
"description":"Rule target updated during in-memory execution."
},
"RuleMemoryRespTargetTO":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Event identifier for the target.",
"example":"42CE52A1AF9A48EBABA25A361F6EC0FE"
},
"formId":{
"type":"string",
"description":"Form identifier for the target.",
"example":"F6DDCE2792924AF8AF633E1CED022FD9"
},
"itemId":{
"type":"string",
"description":"Item identifier for the target.",
"example":"DA1B647C20834350BC2086E1AB8FDFFE"
},
"itemValue":{
"type":"string",
"description":"Updated item value when applicable.",
"example":"target is updated with value"
},
"itemValidation":{
"type":"boolean",
"description":"Validation status resulting from the rule evaluation.",
"example":true
},
"validationComment":{
"type":"string",
"description":"Optional validation comment containing failure details.",
"example":"validation issue"
},
"ruleName":{
"type":"string",
"description":"Rule name.",
"example":"ruleName"
}
},
"description":"Rule target updated during in-memory execution."
},
"CoreDataElementV7":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Primary uuid identifier for the data element instance (HEX, upper case).",
"example":"C1234567C1234567C1234567C1234567"
},
"transactionStart":{
"type":"string",
"description":"Transaction start date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T12:00:00Z"
},
"transactionEnd":{
"type":"string",
"description":"Transaction end date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T13:00:00Z"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D9876543D9876543D9876543D9876543"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":2
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"example":"E5554444E5554444E5554444E5554444"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"example":"F4443333F4443333F4443333F4443333"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Code supplied by vendor.",
"example":"VENDOR42"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Measured value captured for this data element.",
"example":"42.0"
},
"measureUnit":{
"type":"string",
"description":"Unit of measurement for this value (if applicable).",
"example":"mg/dL"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this data entry/edit.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Any general comments for the data element instance.",
"example":"Measured after fasting"
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"propertyId":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) of data capture properties",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2024-01-01T00:00:00Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp from the data source when this element was generated.",
"format":"date-time",
"example":"2024-01-01T00:00:00Z"
},
"documentId":{
"type":"string",
"description":"Unique identifier of the associated source document (hex UUID, 32-character uppercase), enabling traceability between the data element and its original supporting document or file.",
"format":"uuid"
},
"documentVersion":{
"type":"number",
"description":"Version of the source or supporting document linked to this data element.",
"example":1
}
},
"description":"Core data element payload (v7).",
"example":[
]
},
"SubjectScreenContext":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"78DB4EF4847849CCB24EFCCB71CDA436"
},
"subjectNumber":{
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0123"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date for screening",
"format":"date-time",
"example":"2025-12-01T09:00:00Z"
}
},
"description":"Context for subject screening data, including site, event, subject, and visit date."
},
"SubjectScreenDataElementsRequestDto":{
"required":[
"dataElements"
],
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"A1B23C45D67E89F123456789ABCDEF12"
},
"dataElements":{
"type":"array",
"description":"List of data elements input by user in the form",
"items":{
"$ref":"#/components/schemas/CoreDataElementV7"
}
}
},
"description":"Screening subject form and its input data elements."
},
"SubjectScreenRequestDto":{
"required":[
"context",
"forms"
],
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/SubjectScreenContext"
},
"forms":{
"required":[
"dataElements"
],
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"A1B23C45D67E89F123456789ABCDEF12"
},
"dataElements":{
"type":"array",
"description":"List of data elements input by user in the form",
"items":{
"$ref":"#/components/schemas/CoreDataElementV7"
}
}
},
"description":"Screening subject form and its input data elements."
}
},
"description":"Subject screening request, containing enrollment context and submitted forms with data elements."
},
"SubjectScreenPreValidationResponseDto":{
"type":"object",
"properties":{
"sites":{
"type":"array",
"description":"Validation results for each requested site.",
"items":{
"$ref":"#/components/schemas/SubjectScreenSiteValidationDto"
}
}
},
"description":"Response payload for screening pre-validation across requested sites."
},
"SubjectScreenSiteValidationDto":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Site ID validated.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"allowed":{
"type":"boolean",
"description":"Whether screening is allowed for this site.",
"example":false
},
"reason":{
"$ref":"#/components/schemas/SubjectScreenValidationReasonDto"
}
},
"description":"Per-site pre-validation result for screening eligibility."
},
"SubjectScreenValidationReasonDto":{
"type":"object",
"properties":{
"scope":{
"type":"string",
"description":"Validation scope that triggered the block.",
"example":"COUNTRY"
},
"code":{
"type":"string",
"description":"Machine-readable reason code.",
"example":"COUNTRY_SCREENING_LIMIT_REACHED"
},
"message":{
"type":"string",
"description":"UI-facing reason message for why screening is blocked.",
"example":"Enrollment is closed or the screening limit has been reached for this country."
}
},
"description":"Reason details when screening is blocked for a site."
},
"SubjectScreenPreValidationRequestDto":{
"required":[
"siteIds"
],
"type":"object",
"properties":{
"siteIds":{
"type":"array",
"description":"List of site IDs for which screening eligibility needs to be validated.",
"items":{
"type":"string",
"description":"List of site IDs for which screening eligibility needs to be validated."
}
}
},
"description":"Request payload for pre-validating screening eligibility across one or more sites."
},
"DispensedVisit":{
"type":"object",
"properties":{
"visitId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"VisitName":{
"type":"string",
"description":"Name of the dispensed visit",
"example":"Baseline"
}
},
"description":"Represents a dispensed visit instance linked to a subject in a clinical study"
},
"SubjectCountBySiteResponseDto":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Site unique identifier (UUID, 32-character uppercase hex)",
"example":"AABBCCDDEEFF1234567890ABCDEF1234"
},
"totalSubjects":{
"type":"integer",
"description":"Total number of subjects at this site",
"format":"int32",
"example":50
},
"newSubjects":{
"type":"integer",
"description":"Number of new subjects at this site",
"format":"int32",
"example":12
},
"activeSubjects":{
"type":"integer",
"description":"Number of active subjects at this site",
"format":"int32",
"example":40
},
"withdrwanSubjects":{
"type":"integer",
"description":"Number of withdrawn subjects at this site",
"format":"int32",
"example":1
},
"enrolledSubjects":{
"type":"integer",
"description":"Number of enrolled subjects at this site",
"format":"int32",
"example":30
},
"screendSubjects":{
"type":"integer",
"description":"Number of screened subjects at this site",
"format":"int32",
"example":48
},
"screenFailedSubjects":{
"type":"integer",
"description":"Number of subjects who failed screening at this site",
"format":"int32",
"example":1
},
"completedSubjects":{
"type":"integer",
"description":"Number of completed subjects at this site",
"format":"int32",
"example":4
}
},
"description":"Subject count summary for a single site"
},
"SubjectCountResponseDto20":{
"type":"object",
"properties":{
"totalSubjects":{
"type":"integer",
"description":"Total number of subjects",
"format":"int32",
"example":200
},
"newSubjects":{
"type":"integer",
"description":"Number of newly added subjects",
"format":"int32",
"example":12
},
"activeSubjects":{
"type":"integer",
"description":"Number of currently active subjects",
"format":"int32",
"example":160
},
"withdrwanSubjects":{
"type":"integer",
"description":"Number of subjects withdrawn from the study",
"format":"int32",
"example":5
},
"enrolledSubjects":{
"type":"integer",
"description":"Number of subjects who have been enrolled",
"format":"int32",
"example":89
},
"screendSubjects":{
"type":"integer",
"description":"Number of subjects who have been screened",
"format":"int32",
"example":180
},
"screenFailedSubjects":{
"type":"integer",
"description":"Number of subjects who failed screening",
"format":"int32",
"example":4
},
"completedSubjects":{
"type":"integer",
"description":"Number of subjects who completed the study",
"format":"int32",
"example":23
},
"siteSummary":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Site unique identifier (UUID, 32-character uppercase hex)",
"example":"AABBCCDDEEFF1234567890ABCDEF1234"
},
"totalSubjects":{
"type":"integer",
"description":"Total number of subjects at this site",
"format":"int32",
"example":50
},
"newSubjects":{
"type":"integer",
"description":"Number of new subjects at this site",
"format":"int32",
"example":12
},
"activeSubjects":{
"type":"integer",
"description":"Number of active subjects at this site",
"format":"int32",
"example":40
},
"withdrwanSubjects":{
"type":"integer",
"description":"Number of withdrawn subjects at this site",
"format":"int32",
"example":1
},
"enrolledSubjects":{
"type":"integer",
"description":"Number of enrolled subjects at this site",
"format":"int32",
"example":30
},
"screendSubjects":{
"type":"integer",
"description":"Number of screened subjects at this site",
"format":"int32",
"example":48
},
"screenFailedSubjects":{
"type":"integer",
"description":"Number of subjects who failed screening at this site",
"format":"int32",
"example":1
},
"completedSubjects":{
"type":"integer",
"description":"Number of completed subjects at this site",
"format":"int32",
"example":4
}
},
"description":"Subject count summary for a single site"
}
},
"description":"Subject count summary including total, active, withdrawn, enrolled, screen failed and per-site counts"
},
"SubjectNextVisitActionResultDto20":{
"type":"object",
"properties":{
"nextVisitAction":{
"type":"integer",
"description":"Next Visit Action will happen. Its values can be SCREEN_ENABLE, SCREEN_DISABLE, RANDOMIZE_ENABLE, RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE",
"format":"int32"
},
"enableRescreen":{
"type":"boolean",
"description":"boolean indicating if a new rescreen visit can be initiated for the subject",
"example":true
}
}
},
"SubjectMigrationResponseDTO":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":9
},
"eventType":{
"type":"string",
"description":"Event type name tracked for subject migration",
"example":"MIGRATED"
},
"subjectTransferId":{
"type":"string",
"description":"UUID of subject transfer record (if subject was transferred)",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the subject was migrated or synchronized",
"format":"date-time",
"example":"2025-12-01T10:30:51Z"
}
},
"description":"Intermediate subject migration state, including subject audit/meta fields, event and version, and transfer information"
},
"DCSResponse":{
"type":"object",
"properties":{
"result":{
"type":"object"
},
"status":{
"type":"string"
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectMigrationRequest":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectMigrationRequestDTO"
}
},
"description":"Details of subject data for migration request"
},
"SubjectMigrationRequestDTO":{
"required":[
"state",
"subjectNumber"
],
"type":"object",
"properties":{
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0301"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AABBCCDDEEFF1234567890ABCDEF1234"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed.",
"example":"Active"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the migration was triggered/sourced",
"format":"date-time",
"example":"2025-12-01T09:50:00Z"
}
},
"description":"Core subject data for migration request"
},
"SubjectScreenCandidateResponseDto20":{
"required":[
"dataElements",
"subject"
],
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/Subject1"
},
"visit":{
"$ref":"#/components/schemas/VisitsStatus"
},
"dataElements":{
"type":"array",
"description":"All data elements extracted from the screen form for the subject.",
"items":{
"$ref":"#/components/schemas/DataElement"
}
},
"ruleTargets":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Event identifier for the target.",
"example":"42CE52A1AF9A48EBABA25A361F6EC0FE"
},
"formId":{
"type":"string",
"description":"Form identifier for the target.",
"example":"F6DDCE2792924AF8AF633E1CED022FD9"
},
"itemId":{
"type":"string",
"description":"Item identifier for the target.",
"example":"DA1B647C20834350BC2086E1AB8FDFFE"
},
"itemValue":{
"type":"string",
"description":"Updated item value when applicable.",
"example":"target is updated with value"
},
"itemValidation":{
"type":"boolean",
"description":"Validation status resulting from the rule evaluation.",
"example":true
},
"validationComment":{
"type":"string",
"description":"Optional validation comment containing failure details.",
"example":"validation issue"
},
"ruleName":{
"type":"string",
"description":"Rule name.",
"example":"ruleName"
}
},
"description":"Rule target updated during in-memory execution."
}
},
"description":"Subject screening candidate response for v2.0 including rule targets."
},
"SubjectScreenRequestDto20":{
"required":[
"context",
"forms"
],
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/SubjectScreenContext"
},
"forms":{
"required":[
"dataElements"
],
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"A1B23C45D67E89F123456789ABCDEF12"
},
"dataElements":{
"type":"array",
"description":"List of data elements input by user in the form",
"items":{
"$ref":"#/components/schemas/CoreDataElementV7"
}
}
},
"description":"Screening subject form and its input data elements."
}
},
"description":"Subject screening request for v2.0."
},
"SubjectRequest30":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectDto_3"
}
}
},
"SubjectSetting":{
"required":[
"attributeKey",
"attributeValue"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the subject setting.",
"example":"9C67E72C1F2A4BE997B5C0F7A3C91E45"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T00:00:00Z"
},
"attributeKey":{
"type":"string",
"description":"Key of the subject setting attribute. Possible values:
- sequential_across_study_or_site
- limit_screened_subjects
- withdraw_subject_codebreak
- limit_randomize_subjects
- user_enters_screening_visit_date
- user_edits_screening_visit_date
- user_enters_randomization_visit_date
- user_edits_randomization_visit_date
- user_enters_dispensation_visit_date
- user_edits_dispensation_visit_date
- user_enters_non_dispensation_visit_date
- user_edits_non_dispensation_visit_date
- user_enters_optional_visit_date
- user_edits_optional_visit_date
- user_enters_withdraw_visit_date
- user_edits_withdraw_visit_date
- randomization_visit_date_additional_setting
- dispensation_visit_date_additional_setting
- can_dispensation_visit_be_skipped
- can_non_dispensation_visit_be_skipped
- separate_siteid_and_subjectid_hyphen
- limit_study_status
- limit_site_scr
- limit_site_rand
- limit_site_alerts
- limit_site_status
- limit_country_scr
- limit_country_rand
- limit_country_alerts
- limit_country_status
- padding_for_subject_id
- max_randomize_subject
- subject_alerts
- max_screened_subject
- subject_addition_allowed
- subject_number_selection_allowed
- subject_number_format
- retry_partial_sdv_selection
- notify_unsched_visit_failure_only
- notify_screening_failure_only
- notify_optional_visit_failure_only
- notify_nondisp_visit_failure_only
- notify_randomization_failure_only
- notify_dispensation_failure_only
- notify_subjcomplete_visit_failure_only
- show_visit_window
- notify_first_screened_in_study
- notify_first_screened_at_site
- notify_first_randomized_in_study
- notify_first_randomized_at_site
- allow_withdrawal_before_enrollment
- allow_display_signature_elements
- replace_subject_number_rand_number
- code_data_for_new_and_screen_failed_subjects
- blind_rand_number_enabled
- replace_randomisation_enabled
- replace_randomisation_prefix
- replace_randomisation_max_limit
- allow_rescreening
- number_of_rescreen_allowed
- lock_screen_data_on_failure
- user_enters_rescreening_visit_date
- user_edits_rescreening_visit_date
- notify_rescreening_failure_only
- replace_subject_number_enabled
- assign_subject_number
- allow_screen_fail_before_screened
- limit_country_AF_status
- limit_country_AF_scr
- limit_country_AF_alerts
- limit_country_AF_name
- limit_country_AF_rand
- limit_country_DZ_alerts
- limit_country_DZ_rand
- limit_country_DZ_status
- limit_country_DZ_name
- limit_country_DZ_scr
- minimum_subject_number
- allow_withdrawal_for_screen_failed
- allow_completion_for_screen_failed
- enable_assign_subject_number
- limit_study_forced_rand
- limit_site_forced_rand
- enable_assign_subject_number
",
"example":"assign_subject_number"
},
"attributeValue":{
"type":"string",
"description":"String value assigned to this subject setting attribute.",
"example":"YES"
}
},
"description":"Entity representing a single subject setting. Contains business key, value, version, and audit info. Used in requests and responses."
},
"SubjectSettingRequest":{
"type":"object",
"properties":{
"subjectSettings":{
"type":"array",
"description":"List of subject setting objects, each including unique identifier, versioning, key, value, and audit details.",
"items":{
"$ref":"#/components/schemas/SubjectSetting"
}
}
},
"description":"Request payload containing a list of subject settings to create or update."
},
"SubjectSettingDto":{
"required":[
"attributeKey",
"attributeValue"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this operation or audit action.",
"example":"Initial setup"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comments or additional notes for this operation.",
"example":"Enabled based on protocol"
},
"objectVersionNumber":{
"type":"integer",
"description":"Audit trail field that represents the version number of the data.",
"format":"int32",
"example":1
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the subject setting.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T00:00:00Z"
},
"attributeKey":{
"type":"string",
"description":"Key of the subject setting attribute. Possible values:
- sequential_across_study_or_site
- limit_screened_subjects
- withdraw_subject_codebreak
- limit_randomize_subjects
- user_enters_screening_visit_date
- user_edits_screening_visit_date
- user_enters_randomization_visit_date
- user_edits_randomization_visit_date
- user_enters_dispensation_visit_date
- user_edits_dispensation_visit_date
- user_enters_non_dispensation_visit_date
- user_edits_non_dispensation_visit_date
- user_enters_optional_visit_date
- user_edits_optional_visit_date
- user_enters_withdraw_visit_date
- user_edits_withdraw_visit_date
- randomization_visit_date_additional_setting
- dispensation_visit_date_additional_setting
- can_dispensation_visit_be_skipped
- can_non_dispensation_visit_be_skipped
- separate_siteid_and_subjectid_hyphen
- limit_study_status
- limit_site_scr
- limit_site_rand
- limit_site_alerts
- limit_site_status
- limit_country_scr
- limit_country_rand
- limit_country_alerts
- limit_country_status
- padding_for_subject_id
- max_randomize_subject
- subject_alerts
- max_screened_subject
- subject_addition_allowed
- subject_number_selection_allowed
- subject_number_format
- retry_partial_sdv_selection
- notify_unsched_visit_failure_only
- notify_screening_failure_only
- notify_optional_visit_failure_only
- notify_nondisp_visit_failure_only
- notify_randomization_failure_only
- notify_dispensation_failure_only
- notify_subjcomplete_visit_failure_only
- show_visit_window
- notify_first_screened_in_study
- notify_first_screened_at_site
- notify_first_randomized_in_study
- notify_first_randomized_at_site
- allow_withdrawal_before_enrollment
- allow_display_signature_elements
- replace_subject_number_rand_number
- code_data_for_new_and_screen_failed_subjects
- blind_rand_number_enabled
- replace_randomisation_enabled
- replace_randomisation_prefix
- replace_randomisation_max_limit
- allow_rescreening
- number_of_rescreen_allowed
- lock_screen_data_on_failure
- user_enters_rescreening_visit_date
- user_edits_rescreening_visit_date
- notify_rescreening_failure_only
- replace_subject_number_enabled
- assign_subject_number
- allow_screen_fail_before_screened
- limit_country_AF_status
- limit_country_AF_scr
- limit_country_AF_alerts
- limit_country_AF_name
- limit_country_AF_rand
- limit_country_DZ_alerts
- limit_country_DZ_rand
- limit_country_DZ_status
- limit_country_DZ_name
- limit_country_DZ_scr
- minimum_subject_number
- allow_withdrawal_for_screen_failed
- allow_completion_for_screen_failed
- enable_assign_subject_number
- limit_study_forced_rand
- limit_site_forced_rand
- enable_assign_subject_number
",
"example":"assign_subject_number"
},
"attributeValue":{
"type":"string",
"description":"Value of the subject setting attribute.",
"example":"YES"
}
},
"description":"Subject setting data including start version, key/value, and auditing info."
},
"SubjectSettingRequest20":{
"required":[
"SubjectSettingDto"
],
"type":"object",
"properties":{
"SubjectSettingDto":{
"$ref":"#/components/schemas/SubjectSettingDto"
}
},
"description":"Subject setting batch request for v2 API. Contains a list of subject settings."
},
"SubjectSettingDto1":{
"required":[
"attributeKey",
"attributeValue"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Brief reason for the data change.",
"example":"Correction of previous entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments related to the operation.",
"example":"Updated per subject request."
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the subject setting.",
"example":"A591839ABCC4431C8B9FF80219DA1D9A"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T08:00:00Z"
},
"attributeKey":{
"type":"string",
"description":"Key of the subject setting attribute. Possible values:
- sequential_across_study_or_site
- limit_screened_subjects
- withdraw_subject_codebreak
- limit_randomize_subjects
- user_enters_screening_visit_date
- user_edits_screening_visit_date
- user_enters_randomization_visit_date
- user_edits_randomization_visit_date
- user_enters_dispensation_visit_date
- user_edits_dispensation_visit_date
- user_enters_non_dispensation_visit_date
- user_edits_non_dispensation_visit_date
- user_enters_optional_visit_date
- user_edits_optional_visit_date
- user_enters_withdraw_visit_date
- user_edits_withdraw_visit_date
- randomization_visit_date_additional_setting
- dispensation_visit_date_additional_setting
- can_dispensation_visit_be_skipped
- can_non_dispensation_visit_be_skipped
- separate_siteid_and_subjectid_hyphen
- limit_study_status
- limit_site_scr
- limit_site_rand
- limit_site_alerts
- limit_site_status
- limit_country_scr
- limit_country_rand
- limit_country_alerts
- limit_country_status
- padding_for_subject_id
- max_randomize_subject
- subject_alerts
- max_screened_subject
- subject_addition_allowed
- subject_number_selection_allowed
- subject_number_format
- retry_partial_sdv_selection
- notify_unsched_visit_failure_only
- notify_screening_failure_only
- notify_optional_visit_failure_only
- notify_nondisp_visit_failure_only
- notify_randomization_failure_only
- notify_dispensation_failure_only
- notify_subjcomplete_visit_failure_only
- show_visit_window
- notify_first_screened_in_study
- notify_first_screened_at_site
- notify_first_randomized_in_study
- notify_first_randomized_at_site
- allow_withdrawal_before_enrollment
- allow_display_signature_elements
- replace_subject_number_rand_number
- code_data_for_new_and_screen_failed_subjects
- blind_rand_number_enabled
- replace_randomisation_enabled
- replace_randomisation_prefix
- replace_randomisation_max_limit
- allow_rescreening
- number_of_rescreen_allowed
- lock_screen_data_on_failure
- user_enters_rescreening_visit_date
- user_edits_rescreening_visit_date
- notify_rescreening_failure_only
- replace_subject_number_enabled
- assign_subject_number
- allow_screen_fail_before_screened
- limit_country_AF_status
- limit_country_AF_scr
- limit_country_AF_alerts
- limit_country_AF_name
- limit_country_AF_rand
- limit_country_DZ_alerts
- limit_country_DZ_rand
- limit_country_DZ_status
- limit_country_DZ_name
- limit_country_DZ_scr
- minimum_subject_number
- allow_withdrawal_for_screen_failed
- allow_completion_for_screen_failed
- enable_assign_subject_number
- limit_study_forced_rand
- limit_site_forced_rand
- enable_assign_subject_number
",
"example":"limit_screened_subjects"
},
"attributeValue":{
"type":"string",
"description":"Value for the subject-level setting key.",
"example":"true"
}
},
"description":"Subject setting version 1 DTO, extends audit fields with attribute key/value and version metadata."
},
"SubjectTransfer":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the subject involved in the transfer.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred from.",
"example":"938D23FA6B7241CCA41BD627E5DB60DA"
},
"toSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred to.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the entity creation or latest modification.",
"example":"Initial import."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment regarding the last change made to the entity.",
"example":"Imported via migration tool."
},
"operationType":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"REMOVED"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the subject transfer record.",
"example":"A1B2C3D4E5F64789AABBCCDDEEFF1122"
},
"versionStart":{
"type":"string",
"description":"Timestamp representing the start of the version for this record.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Subject number before transfer.",
"example":"SUBJ-0001"
},
"newSubjectNumber":{
"type":"string"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number associated with the subject, if assigned.",
"example":"RANDOM123"
}
},
"description":"Represents a subject transfer between sites, including identifiers and audit metadata.",
"example":{
"id":"A1B2C3D4E5F64789AABBCCDDEEFF1122",
"versionStart":"2023-01-01T09:00:00Z",
"subjectId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"subjectNumber":"SUBJ-0001",
"newSubjectNumber":"SUBJ-0001-NEW",
"fromSiteId":"938D23FA6B7241CCA41BD627E5DB60DA",
"toSiteId":"699EF3745FC545589F186D2198F3C65E",
"randomizationNumber":"RANDOM123",
"reason":"Site change",
"comment":"Transferred due to site closure"
}
},
"SubjectTransferDto":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the subject being transferred.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred from.",
"example":"938D23FA6B7241CCA41BD627E5DB60DA"
},
"toSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred to.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the subject transfer.",
"example":"Site change"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment or note about the subject transfer.",
"example":"Moved subject to new site"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the subject transfer record.",
"example":"A1B2C3D4E5F64789AABBCCDDEEFF1122"
},
"versionStart":{
"type":"string",
"description":"Timestamp representing the start of the version for this subject transfer record.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"newSubjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"New subject number after transfer or renumbering.",
"example":"SUBJ-0001-NEW"
}
},
"description":"Represents a subject transfer between sites used for API request/response bodies."
},
"SubjectTransferRequestDto":{
"type":"object",
"properties":{
"subjectTransfer":{
"$ref":"#/components/schemas/SubjectTransferDto"
}
},
"description":"Subject transfer request payload. Contains the subjectTransfer object representing details of a transfer."
},
"VisitsStatusDto":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Base visit status information including identity, study metadata and status fields"
},
"VisitsStatusDto4":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
}
},
"description":"Visit status including the specific event instance number within a repeating schedule"
},
"MultipleVisitsStatusRequestDto":{
"type":"object",
"properties":{
"visitDetails":{
"type":"array",
"description":"List of visit details containing subject and event identifiers.",
"example":[
{
"subjectId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"eventId":"53915DD9B758466AB2226CBCC4466B7E"
}
],
"items":{
"$ref":"#/components/schemas/VisitDetails"
}
}
},
"description":"Request payload containing a list of visit details for which visit statuses are requested."
},
"VisitDetails":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"53915DD9B758466AB2226CBCC4466B7E"
}
},
"description":"Subject and event identifier pair used to query visit status",
"example":[
{
"subjectId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"eventId":"53915DD9B758466AB2226CBCC4466B7E"
}
]
},
"SubjectVisitsReq":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subject identifiers in UUID, 32-character uppercase hexadecimal string",
"example":[
"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"2ABC8A2C11045A584ADEA8760F72B114"
],
"items":{
"type":"string",
"description":"List of subject identifiers in UUID, 32-character uppercase hexadecimal string",
"format":"uuid"
}
}
},
"description":"Request payload containing a list of subject identifiers."
},
"VisitDynamicAssoFormsResponse":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"isVisible":{
"type":"boolean",
"description":"Flag indicating if the form should be visible on the visit for the subject",
"example":true
},
"formType":{
"type":"integer",
"description":"Form type indicator where 0 represents ASSOCIATED_FORM and 1 represents DYNAMIC_FORM",
"format":"int32",
"example":0
}
},
"description":"Response object describing dynamic or associated form visibility for a given visit."
},
"SubjectAECountDto":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"53915DD9B758466AB2226CBCC4466B7E"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
}
},
"description":"Adverse event count details per subject and event in a given study version."
},
"VisitDataMigrationDtoV1":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"A1B2C3D4E5F6471890ABCDEF12345678"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"53915DD9B758466AB2226CBCC4466B7E"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"8F2B7E6C5D4A3B2C1D0E9F8A7B6C5D4E"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"All data verified"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"9F8E7D6C5B4A3A2B1C0D9E8F7A6B5C4D"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"sourceTimeStamp":{
"type":"string",
"description":"Source timestamp when the record was generated in the source system",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"visitStartDate":{
"type":"string",
"description":"Date of visit",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"Visit data migration payload/response containing identity, versioning, visit status and timing fields."
},
"VisitDataMigrationRequest":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"53915DD9B758466AB2226CBCC4466B7E"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"8F2B7E6C5D4A3B2C1D0E9F8A7B6C5D4E"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date-time in ISO 8601 UTC",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp in ISO 8601 UTC",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"Request payload to migrate visit data for a subject and event. Contains identifiers and timestamps."
},
"SubjectVisitInfo":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A1B2C3D4E5F6471890ABCDEF12345678"
},
"subjectNumber":{
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-001"
},
"screeningNumber":{
"type":"string",
"description":"Screening number captured for the subject",
"example":"SCR-0001"
},
"visits":{
"type":"array",
"description":"List of visit details for the subject",
"example":[
{
"eventId":"53915DD9B758466AB2226CBCC4466B7E",
"eventInstanceNum":1,
"visitStartDate":"2023-01-01T09:00:00Z"
}
],
"items":{
"$ref":"#/components/schemas/VisitInfoDetail"
}
}
},
"description":"Subject level visit information including subject identifiers and visit details."
},
"SubjectVisitInfoResponse":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitInfo"
}
}
}
},
"VisitInfoDetail":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"53915DD9B758466AB2226CBCC4466B7E"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"visitStartDate":{
"type":"string",
"description":"Date of visit",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"Visit detail containing event identifier, optional instance number, and optional start date.",
"example":[
{
"eventId":"53915DD9B758466AB2226CBCC4466B7E",
"eventInstanceNum":1,
"visitStartDate":"2023-01-01T09:00:00Z"
}
]
},
"DcsResponseSubjectVisitInfoResponse":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitInfoResponse"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectVisitInfoRequest":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subjects with requested visit details.",
"example":[
{
"subjectId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"visits":[
{
"eventId":"53915DD9B758466AB2226CBCC4466B7E",
"eventInstanceNum":1
}
]
}
],
"items":{
"$ref":"#/components/schemas/SubjectVisitsInfoReq"
}
}
},
"description":"Request payload to retrieve subject visit information with specific events and instances."
},
"SubjectVisitsInfoReq":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Subject identifier in uppercase hex UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"visits":{
"type":"array",
"description":"Requested visit detail filters for this subject",
"example":[
{
"eventId":"53915DD9B758466AB2226CBCC4466B7E",
"eventInstanceNum":1
}
],
"items":{
"$ref":"#/components/schemas/VisitInfoDetailReq"
}
}
},
"description":"Subject with optional visit filters for retrieving visit information.",
"example":[
{
"subjectId":"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"visits":[
{
"eventId":"53915DD9B758466AB2226CBCC4466B7E",
"eventInstanceNum":1
}
]
}
]
},
"VisitInfoDetailReq":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"53915DD9B758466AB2226CBCC4466B7E"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
}
},
"description":"Requested visit detail including event identifier and optional instance number.",
"example":[
{
"eventId":"53915DD9B758466AB2226CBCC4466B7E",
"eventInstanceNum":1
}
]
},
"CodedDerrivedItemsRequest":{
"required":[
"source_value"
],
"type":"object",
"properties":{
"source_propertyId":{
"type":"string",
"description":"Source property Unique identifier(UUID, 32-character uppercase hexadecimal string). Must be unique per data context.",
"example":"A3B9C7D6E8F041BBA1C7B3C8E182D43A"
},
"source_value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"The original/raw value from the source.",
"example":"ALT"
},
"codeValuesList":{
"required":[
"code_value"
],
"type":"object",
"properties":{
"coding_info_id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding info used to derive the code.",
"example":"3A1A5E8B0F894A9CA9F324D04B162F23"
},
"item_id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"5B3B7E0ED4F24E30B5A3A44C5A896C90"
},
"target_id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding result target.",
"example":"F843B5478028498882E3AF11FEBA3F2A"
},
"code_value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"The actual code value derived from the coding process.",
"example":"R79.0"
}
},
"description":"Represents a coded value applied to a source value. Includes coding information, item and target identifiers and the coded result."
}
},
"description":"Request object for inserting or updating coded values for a source, with a list of codes applied."
},
"CodedDataDTO":{
"title":"CodedDataDTO",
"required":[
"Id",
"eventName",
"eventRefName",
"formId",
"formName",
"formRefName",
"itemId",
"itemName",
"itemRefName",
"siteId",
"siteMnemonic",
"siteName",
"studyVersion",
"subjectId",
"subjectInitials",
"subjectNumber",
"value",
"visitId"
],
"type":"object",
"properties":{
"subjectInitials":{
"type":"string",
"description":"Subject initials as captured in study.",
"example":"JD"
},
"siteName":{
"type":"string",
"description":"Name of the clinical site.",
"example":"Main Site"
},
"siteMnemonic":{
"type":"string",
"description":"Mnemonic code of the site.",
"example":"SITE001"
},
"formRefName":{
"type":"string",
"description":"Reference name of the form as defined in the study design.",
"example":"AE_FORM"
},
"formName":{
"type":"string",
"description":"Display name of the form.",
"example":"Adverse Events"
},
"itemRefName":{
"type":"string",
"description":"Reference name of the data item as defined in the study design.",
"example":"AE_TERM"
},
"itemName":{
"type":"string",
"description":"Display name of the data item.",
"example":"Adverse Event Term"
},
"eventRefName":{
"type":"string",
"description":"Reference name of the study event as defined in the study design.",
"example":"VISIT_1"
},
"eventName":{
"type":"string",
"description":"Display name of the study event.",
"example":"Visit 1"
},
"Id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the coded data record.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A1B2C3D4E5F647839ABCDEF012345678"
},
"visitId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the visit",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"938D23FA6B7241CCA41BD627E5DB60DA"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"D4E5F6A1B2C347839ABCDEF012345678"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"value":{
"type":"string",
"description":"Verbatim or coded value captured for the item.",
"example":"Headache"
},
"subjectNumber":{
"type":"string",
"description":"Subject number assigned within the study.",
"example":"SUBJ-0001"
},
"context":{
"type":"string",
"description":"Additional context information for the coded value.",
"example":"{}"
},
"verstionStart":{
"type":"string",
"description":"Record version start timestamp.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"dataElementId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the underlying data element.",
"example":"318148C517104168B7F7AA90EA888DDA"
}
},
"description":"Represents coded data details for a verbatim term including identifiers for study, subject, visit, form, item and associated metadata."
},
"CodeDataRequest":{
"type":"object",
"properties":{
"sourceIds":{
"type":"array",
"description":"A list of upper-case hexadecimal UUID strings identifying source objects for coding.",
"example":[
"123E4567E89B12D3A456426655440000",
"123E4567E89B12D3A45642665544AAAA"
],
"items":{
"type":"string",
"description":"A list of upper-case hexadecimal UUID strings identifying source objects for coding.",
"example":"[\"123E4567E89B12D3A456426655440000\",\"123E4567E89B12D3A45642665544AAAA\"]"
}
}
},
"description":"Request object for retrieving coded data using a set of source IDs."
},
"CodedDerrivedItemsResponse":{
"type":"object",
"properties":{
"source_propertyId":{
"type":"string",
"description":"Source property Unique identifier(UUID, 32-character uppercase hexadecimal string). Must be unique per data context.",
"example":"A3B9C7D6E8F041BBA1C7B3C8E182D43A"
},
"source_value":{
"type":"string",
"description":"The original/raw value from the source.",
"example":"ALT"
},
"codeValuesList":{
"type":"object",
"properties":{
"coding_info_id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding info used to derive the code.",
"example":"3A1A5E8B0F894A9CA9F324D04B162F23"
},
"dataElement":{
"$ref":"#/components/schemas/DataElementDto"
},
"source_propertyId":{
"type":"string",
"description":"Source property Unique identifier(UUID, 32-character uppercase hexadecimal string). Must be unique per data context.",
"format":"UUID",
"example":"C2D20B70E856463EBC6C830C693D1B40"
},
"source_value":{
"type":"string",
"description":"Original value from the source that is being coded.",
"example":"ALT"
}
},
"description":"Represents a coded item in a data element response, including identifiers, source value, and a referenced DataElement object."
}
},
"description":"Response object containing coded items for a given source, including property, value, and applied codes."
},
"DataElementCodedItemsDto":{
"type":"object",
"properties":{
"coding_info_id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding info used to derive the code.",
"example":"3A1A5E8B0F894A9CA9F324D04B162F23"
},
"dataElement":{
"$ref":"#/components/schemas/DataElementDto"
},
"source_propertyId":{
"type":"string",
"description":"Source property Unique identifier(UUID, 32-character uppercase hexadecimal string). Must be unique per data context.",
"format":"UUID",
"example":"C2D20B70E856463EBC6C830C693D1B40"
},
"source_value":{
"type":"string",
"description":"Original value from the source that is being coded.",
"example":"ALT"
}
},
"description":"Represents a coded item in a data element response, including identifiers, source value, and a referenced DataElement object."
},
"EHRCategoryDTO":{
"type":"object",
"properties":{
"recordedDate":{
"type":"string",
"description":"The date/time clinical data was recorded for this EHR category record.",
"format":"date-time",
"example":"2023-10-01T08:15:00Z"
},
"recordedData":{
"$ref":"#/components/schemas/EHRRecordedDataDTO"
}
},
"description":"Represents a single record within an OCC EHR category, corresponding to measured or recorded clinical data at a point in time. Includes a list of the individual data points."
},
"EHRDataAttributesDTO":{
"type":"object",
"properties":{
"parentName":{
"type":"string",
"description":"Parent name or grouping for this clinical property or attribute.",
"example":"Lab Panel"
},
"name":{
"type":"string",
"description":"Canonical name of the measured property or attribute.",
"example":"Hemoglobin"
},
"values":{
"type":"array",
"description":"Recorded values for this property.",
"example":[
"13.7"
],
"items":{
"type":"string",
"description":"Recorded values for this property.",
"example":"[\"13.7\"]"
}
},
"units":{
"type":"string",
"description":"Units for the measured property value.",
"example":"g/dL"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"C091C9D975C44E87B8D417C3AC867A43"
},
"occCodes":{
"type":"array",
"description":"OCC codes referencing controlled vocabulary/clinical mapping.",
"example":[
"2.16.840.1.113883.5.50"
],
"items":{
"type":"string",
"description":"OCC codes referencing controlled vocabulary/clinical mapping.",
"example":"[\"2.16.840.1.113883.5.50\"]"
}
},
"sourceUnit":{
"type":"string",
"description":"Original source unit for the measurement.",
"example":"g/dL"
},
"sourceValue":{
"type":"string",
"description":"Original source value for the measurement.",
"example":"13.7"
}
},
"description":"Detailed attribute or measured value associated with an OCC EHR clinical record. Includes property name, value, units, codes and HDI identifier."
},
"EHRRecordedDataDTO":{
"type":"object",
"properties":{
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"D2E9219A568740A78CC570066F56C2D6"
},
"attributes":{
"$ref":"#/components/schemas/EHRDataAttributesDTO"
}
},
"description":"Stores the individual recorded EHR data values for a given measurement, with HDI identifier and clinical data attributes."
},
"OCCCategoryDataDto":{
"type":"object",
"properties":{
"category":{
"type":"string",
"description":"The OCC EHR category type can be of LABS, MEDICAL, MEDICATIONHISTORY, VITALS, DEMOGRAPHICS, PROCEDURES.",
"example":"LABS"
},
"categoryData":{
"$ref":"#/components/schemas/EHRCategoryDTO"
}
},
"description":"Represents a category of EHR data associated with a subject for a specific visit event in OCC. Contains the name of the EHR category and the list of category data records retrieved for the subject."
},
"PaginatedResponseOCCCategoryDataDto":{
"type":"object",
"properties":{
"hasMore":{
"type":"boolean"
},
"totalResults":{
"type":"integer",
"format":"int32"
},
"count":{
"type":"integer",
"format":"int32"
},
"limit":{
"type":"integer",
"format":"int32"
},
"offset":{
"type":"integer",
"format":"int32"
},
"resultData":{
"$ref":"#/components/schemas/OCCCategoryDataDto"
}
}
},
"EHRtoEDCAddressDTO":{
"type":"object",
"properties":{
"city":{
"type":"string",
"description":"Name of the city for patient residence.",
"example":"Los Angeles"
},
"state":{
"type":"string",
"description":"Two-letter state code.",
"example":"CA"
}
},
"description":"Simple postal address details for an EHR patient."
},
"EHRtoEDCPatientInfoDTO":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Uppercase HEX patient unique identifier.",
"example":"C0A8010AC8ED432F8A2AD12B28F95C84"
},
"mrn":{
"type":"string",
"description":"Medical record number for patient.",
"example":"MRN13456"
},
"name":{
"type":"string",
"description":"Patient's full name.",
"example":"Jane Doe"
},
"gender":{
"type":"string",
"description":"Gender/sex of the patient (e.g. 'MALE', 'FEMALE').",
"example":"FEMALE"
},
"dateOfBirth":{
"type":"string",
"description":"Date of birth in ISO format YYYY-MM-DD.",
"format":"date",
"example":"1979-03-22"
},
"address":{
"$ref":"#/components/schemas/EHRtoEDCAddressDTO"
}
},
"description":"DTO representing detailed EHR patient demographics for MRN-based lookup."
},
"EHRtoEDCPatientLinkStatusRequestDTO":{
"type":"object",
"properties":{
"siteIds":{
"type":"array",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":[
"AA12BB34CC56DD78EE90FF98DD11CC22",
"11223344AABBCC55DD66EE77FF88GG99"
],
"items":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"uuid"
}
}
},
"description":"Request DTO for querying the EHR-to-EDC patient link status for a set of site IDs."
},
"EHRtoEDCPatientLinkStatusCollectionDTO":{
"type":"object",
"properties":{
"subjectLinks":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AB12CD34EF56A7890B12C34D56EF7890"
},
"subjectLinkStatus":{
"type":"string",
"description":"The EHR/EDC patient link status it values can LINKED/UNLINKED).",
"example":"LINKED"
}
},
"description":"Result DTO detailing link status for a site in an EHR-to-EDC patient link status response."
}
},
"description":"Response wrapper containing an array of patient link statuses for one or more sites."
},
"EHRtoEDCPatientLinkStatusDTO":{
"type":"object",
"properties":{
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AB12CD34EF56A7890B12C34D56EF7890"
},
"subjectLinkStatus":{
"type":"string",
"description":"The EHR/EDC patient link status it values can LINKED/UNLINKED).",
"example":"LINKED"
}
},
"description":"Result DTO detailing link status for a site in an EHR-to-EDC patient link status response."
},
"ContextEhr":{
"required":[
"studyName",
"studyVersion"
],
"type":"object",
"properties":{
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.0"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"65DFE0E1F48C4097A0F6B1F7A1F9F8C8"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AEBC7137B253422D8A23C8C12B8DF125"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2E4567890ABCDEF1234567890ABCDEF0"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"The user-friendly name of the study.",
"example":"Clinical Study ABC"
},
"validateOCCData":{
"type":"boolean",
"description":"Pass true if submitted data should be OCC validated, otherwise false.",
"example":false
}
},
"description":"Submission context for an EHR data operation, identifying the study, subject, event, and site details."
},
"CoreDataEHRFormElementRequestDto":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"85B29A9062BD4C8B9584E0907A37A84A"
},
"dataElements":{
"$ref":"#/components/schemas/CoreDataElementEhr"
}
},
"description":"Represents a form definition and set of core data elements to be submitted as part of an EHR save operation."
},
"CoreDataElementEhr":{
"type":"object",
"properties":{
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"C1234567C1234567C1234567C1234567"
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"recordedDate":{
"type":"string",
"description":"Calendar date/time the data was originally recorded.",
"format":"date-time",
"example":"2023-01-01T07:00:00Z"
},
"occCodes":{
"type":"array",
"description":"List of OCC codes associated with this data element instance.",
"example":[
"2.16.840.1.113883.5.50"
],
"items":{
"type":"string",
"description":"List of OCC codes associated with this data element instance.",
"example":"[\"2.16.840.1.113883.5.50\"]"
}
},
"id":{
"type":"string",
"description":"Primary uuid identifier for the data element instance (HEX, upper case).",
"example":"C1234567C1234567C1234567C1234567"
},
"transactionStart":{
"type":"string",
"description":"Transaction start date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T12:00:00Z"
},
"transactionEnd":{
"type":"string",
"description":"Transaction end date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T13:00:00Z"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D9876543D9876543D9876543D9876543"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":2
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"example":"E5554444E5554444E5554444E5554444"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"example":"F4443333F4443333F4443333F4443333"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Code supplied by vendor.",
"example":"VENDOR42"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Measured value captured for this data element.",
"example":"42.0"
},
"measureUnit":{
"type":"string",
"description":"Unit of measurement for this value (if applicable).",
"example":"mg/dL"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this data entry/edit.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Any general comments for the data element instance.",
"example":"Measured after fasting"
},
"sourceValue":{
"type":"string",
"description":"Source value for this element as provided in upstream system.",
"format":"date-time",
"example":"2024-08-26T14:57:36.039373-07:00"
},
"sourceUnit":{
"type":"string",
"description":"Source units for this value.",
"example":"258677007"
}
},
"description":"Represents a single EHR data element instance submitted as part of a form with supporting metadata and identifiers."
},
"DataElementsEhrRequestDto":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/ContextEhr"
},
"forms":{
"$ref":"#/components/schemas/CoreDataEHRFormElementRequestDto"
}
},
"description":"Request payload for saving EHR data elements for a subject in a study visit event, including context and a list of EHR form data submissions."
},
"DataElementDto15":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"sourceTimeStamp":{
"type":"string",
"description":"Source timestamp for this data element version.",
"format":"date-time",
"example":"2024-03-15T10:22:11Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"D2E9219A568740A78CC570066F56C2D6"
},
"operation":{
"type":"string",
"description":"Indicates the type of operation performed on a data element like update, clear, insert",
"example":"insert"
}
},
"description":"Represents a single data element involved in an EHR form association request/response, with identifying and status fields."
},
"DataElementDto130":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the data element was captured in the source system",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Data element details including source timestamp from source system."
},
"DataElementsFormAssociationsDto31":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements returned for the visit",
"items":{
"$ref":"#/components/schemas/DataElementDto11"
}
},
"formsAssociations":{
"type":"array",
"description":"List of form association mappings for the visit",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
}
},
"description":"Container holding visit data elements and their form associations"
},
"DcsResponseDataElementsFormAssociationsDto31":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/DataElementsFormAssociationsDto31"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElementFormAssociationsReq21":{
"type":"object",
"properties":{
"formsAssociations":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormAssociationsDataElmntsReqDto21"
}
},
"context":{
"$ref":"#/components/schemas/Context2"
},
"dataElements":{
"type":"array",
"description":"List of data elements to process for the given context.",
"items":{
"$ref":"#/components/schemas/CoreDataElementV4"
}
}
}
},
"FormAssociationsDataElmntsReqDto21":{
"type":"object",
"properties":{
"associatedEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"associatedEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"associatedFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"associatedRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"example":1
},
"srcItemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"associatedStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.9"
},
"srcFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A0B1C2D3E4F5678901234567890ABCDE"
},
"associatedFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"B1C2D3E4F5678901234567890ABCDE0A"
},
"associatedRepeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
}
},
"description":"Extended form associations request with section and repeat form details"
},
"DataElementDto14":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"propertyVersionStart":{
"type":"string",
"description":"Study version start",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"lockedStatus":{
"type":"string",
"description":"Lock state of the data element. Values LOCKED, UNLOCKED, NEVER_LOCKED",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the data element lock state last changed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
},
"description":"DataElement details."
},
"DataElementRequestDto14":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto14"
}
},
"description":"Request wrapper containing DataElementDto14 payload."
},
"DcsResponseListSubjectRespDto13":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectRespDto13"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"ScheduledVisitsDto20":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"title":{
"type":"string",
"description":"Display title for the visit",
"example":"Baseline"
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Window start date for scheduling the visit",
"format":"date-time",
"example":"2025-10-10T14:30:31.892Z"
},
"scheduledDate":{
"type":"string",
"description":"Scheduled date for the visit",
"format":"date-time",
"example":"2025-10-12T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Window end date for scheduling the visit",
"format":"date-time",
"example":"2025-10-20T14:30:31.892Z"
},
"eventInstanceNum":{
"type":"number",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"cycleCount":{
"type":"number",
"description":"Cycle count for the visit",
"format":"int32",
"example":1
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
}
},
"description":"Scheduled visit details including scheduling windows and action to be taken"
},
"SubjectsVisitScheduleDto100":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectRespDto14"
},
"visits":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Locked status for the visit start date.Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
},
"doseHoldAction":{
"type":"string",
"description":"Dose hold action for the visit. The acceptable values are ENABLE or DISABLE",
"example":"ENABLE"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries associated with this visit",
"format":"int32",
"example":0
}
},
"description":"List of visit status for each actual or projected visit"
},
"scheduledVisits":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"title":{
"type":"string",
"description":"Display title for the visit",
"example":"Baseline"
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Window start date for scheduling the visit",
"format":"date-time",
"example":"2025-10-10T14:30:31.892Z"
},
"scheduledDate":{
"type":"string",
"description":"Scheduled date for the visit",
"format":"date-time",
"example":"2025-10-12T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Window end date for scheduling the visit",
"format":"date-time",
"example":"2025-10-20T14:30:31.892Z"
},
"eventInstanceNum":{
"type":"number",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"cycleCount":{
"type":"number",
"description":"Cycle count for the visit",
"format":"int32",
"example":1
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
}
},
"description":"Scheduled visit details including scheduling windows and action to be taken"
},
"crntStateStudyVrsn":{
"type":"string",
"description":"Study version for the current visit/subject state",
"example":"3.0.0.4"
}
},
"description":"Schedule and status of all planned and actual subject visits, including current subject and visit state details, visit windows, and projected visits."
},
"VisitsStatusDto14":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Locked status for the visit start date.Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
},
"doseHoldAction":{
"type":"string",
"description":"Dose hold action for the visit. The acceptable values are ENABLE or DISABLE",
"example":"ENABLE"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries associated with this visit",
"format":"int32",
"example":0
}
},
"description":"List of visit statuses, including query counts, lock status, windowing, and other state."
},
"VisitWindowInfoDTO":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0A1B2C3D4E5F6A7B8C9D0E1F2A3B4C5D"
},
"visitName":{
"type":"string",
"description":"Name of the visit as defined in the protocol.",
"example":"Screening"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"scheduledDate":{
"type":"string",
"description":"Start date/time of the schedule for the visit",
"format":"date-time",
"example":"2025-11-05T10:00:00Z"
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Start date/time of the scheduled window for the visit.",
"format":"date-time",
"example":"2025-11-01T08:00:00Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"End date/time of the scheduled window for the visit.",
"format":"date-time",
"example":"2025-11-10T17:00:00Z"
},
"isSkipped":{
"type":"boolean",
"description":"Flag indicating if the visit was skipped.",
"example":false
}
},
"description":"DTO containing detailed visit window information for a subject's visit schedule in a study, including event and visit identifier, dates and flags."
},
"DcsResponseListVisitWindowInfoDTO":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitWindowInfoDTO"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"ScheduledVisitsDto":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"title":{
"type":"string",
"description":"Display title for the visit",
"example":"Baseline"
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Window start date for scheduling the visit",
"format":"date-time",
"example":"2025-10-10T14:30:31.892Z"
},
"scheduledDate":{
"type":"string",
"description":"Scheduled date for the visit",
"format":"date-time",
"example":"2025-10-12T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Window end date for scheduling the visit",
"format":"date-time",
"example":"2025-10-20T14:30:31.892Z"
},
"eventInstanceNum":{
"type":"number",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"cycleCount":{
"type":"number",
"description":"Cycle count for the visit",
"format":"int32",
"example":1
}
},
"description":"Base scheduled visit details including scheduling windows and identifiers"
},
"SubjectVisitsDto80":{
"type":"object",
"properties":{
"subjectId":{
"type":"string"
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto12"
}
},
"scheduledVisits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ScheduledVisitsDto"
}
},
"crntStateStudyVrsn":{
"type":"string"
},
"signedStatus":{
"type":"string"
},
"verifiedStatus":{
"type":"string"
},
"freezedStatus":{
"type":"string"
},
"lastSigned":{
"type":"string"
}
}
},
"SubjectVisitsStatusResponse80":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto80"
}
}
}
},
"DcsResponseSubjectVisitsStatusResponse80":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse80"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElementDto131":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the data element was captured in the source system",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock state of the data element. Values LOCKED, UNLOCKED, NEVER_LOCKED",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the data element lock state last changed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"NEVER_LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date lock state last changed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"DataElementDto is a wrapper containing DataElementDto130 and additional fields like lockedStatus, lockedDateTime, visitStartDateLockedStatus and visitStartDateLockedDateTime."
},
"CoreDataElementV5":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Primary uuid identifier for the data element instance (HEX, upper case).",
"example":"C1234567C1234567C1234567C1234567"
},
"transactionStart":{
"type":"string",
"description":"Transaction start date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T12:00:00Z"
},
"transactionEnd":{
"type":"string",
"description":"Transaction end date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T13:00:00Z"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D9876543D9876543D9876543D9876543"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":2
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"example":"E5554444E5554444E5554444E5554444"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"example":"F4443333F4443333F4443333F4443333"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Code supplied by vendor.",
"example":"VENDOR42"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Measured value captured for this data element.",
"example":"42.0"
},
"measureUnit":{
"type":"string",
"description":"Unit of measurement for this value (if applicable).",
"example":"mg/dL"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this data entry/edit.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Any general comments for the data element instance.",
"example":"Measured after fasting"
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"propertyId":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) of data capture properties",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2024-01-01T00:00:00Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
}
},
"description":"Core data element payload (v5)."
},
"DataElementFormAssociationsReq2":{
"type":"object",
"properties":{
"formsAssociations":{
"type":"array",
"description":"List of form association definitions to apply",
"items":{
"$ref":"#/components/schemas/FormAssociationsDataElmntsReqDto21"
}
},
"context":{
"$ref":"#/components/schemas/Context3"
},
"dataElements":{
"type":"array",
"description":"List of core data element payloads to be processed",
"items":{
"$ref":"#/components/schemas/CoreDataElementV5"
}
}
},
"description":"Request wrapper that includes data elements and corresponding form associations to update"
},
"SubjectsVisitScheduleDto110":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectRespDto16"
},
"visits":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Locked status for the visit start date.Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
},
"doseHoldAction":{
"type":"string",
"description":"Dose hold action for the visit. The acceptable values are ENABLE or DISABLE",
"example":"ENABLE"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries associated with this visit",
"format":"int32",
"example":0
}
},
"description":"List of visit status for each actual or projected visit"
},
"scheduledVisits":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"title":{
"type":"string",
"description":"Display title for the visit",
"example":"Baseline"
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Window start date for scheduling the visit",
"format":"date-time",
"example":"2025-10-10T14:30:31.892Z"
},
"scheduledDate":{
"type":"string",
"description":"Scheduled date for the visit",
"format":"date-time",
"example":"2025-10-12T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Window end date for scheduling the visit",
"format":"date-time",
"example":"2025-10-20T14:30:31.892Z"
},
"eventInstanceNum":{
"type":"number",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"cycleCount":{
"type":"number",
"description":"Cycle count for the visit",
"format":"int32",
"example":1
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
}
},
"description":"Scheduled visit details including scheduling windows and action to be taken"
},
"crntStateStudyVrsn":{
"type":"string",
"description":"Study version for the current visit/subject state",
"example":"3.0.0.4"
}
},
"description":"Schedule and status of all planned and actual subject visits, including current subject and visit state details, visit windows, and projected visits."
},
"SubjectVisitsDto90":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique subject identifier representing the participant enrolled in the study",
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
},
"visits":{
"type":"array",
"description":"List of visit status records for the subject",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto12"
}
},
"scheduledVisits":{
"type":"array",
"description":"List of scheduled visits with scheduling windows",
"items":{
"$ref":"#/components/schemas/ScheduledVisitsDto"
}
},
"crntStateStudyVrsn":{
"type":"string",
"description":"String representing the version of the study configuration or protocol. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"signedStatus":{
"type":"string",
"description":"Subject-level signed status aggregated across visits",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Subject-level verified status aggregated across visits",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Subject-level freeze status aggregated across visits",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp of the last sign action for the subject",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"lockedStatus":{
"type":"string",
"description":"Subject-level locked status",
"example":"LOCKED"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if subject can be completed based on current data and rules",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked, if applicable",
"example":"3.0.0.1"
}
},
"description":"Subject level visit status summary including current statuses, scheduled visits and schedules."
},
"DcsResponseSubjectVisitsStatusResponse90":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse90"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectVisitsStatusResponse90":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subjects with visit status and schedule information.",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto90"
}
}
},
"description":"Response wrapper containing a list of subjects with visit status details and schedules."
},
"VisitStatusRulesTargetWithSVFDto8":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"targets":{
"type":"array",
"description":"List of rule targets affected by this operation",
"example":[
"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC"
],
"items":{
"type":"string",
"description":"List of rule targets affected by this operation",
"example":"[\"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC\"]"
}
},
"associatedStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"visitStartDateFreezeStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"LOCKED"
},
"visitStartDateVerifyStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFY"
},
"visitStartDateSignStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
}
}
},
"DataElementDto134":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the data element was captured in the source system",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock state of the data element. Values LOCKED, UNLOCKED, NEVER_LOCKED",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the data element lock state last changed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"NEVER_LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date lock state last changed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"affidavitCodeValue":{
"type":"string",
"description":"Affidavit code value when affidavit applies",
"example":"Electronic Signature Affidavit"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"C1234567C1234567C1234567C1234567"
}
},
"description":"DataElementDto is a wrapper containing data fields regarding the dataElement like : hdiId, affidavitCodeValue, lockedDateTime, visitStartDateLockedStatus, visitStartDateLockedDateTime etc."
},
"DataElementDto123":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"LOCK"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the data element was captured in the source system",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the data element. Acceptable Values are LOCKED, NOT_APPLICABLE",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the data element was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"93CC828113AC439181071CB44D2C6FE5"
},
"documentId":{
"type":"string",
"description":"Unique identifier of the associated source document (hex UUID, 32-character uppercase), enabling traceability between the data element and its original supporting document or file.",
"example":"93CC828113AC439181071CB44D2C6FE5"
},
"documentVersion":{
"type":"number",
"description":"Document version number",
"example":1
},
"validationRules":{
"type":"array",
"description":"Validation rules evaluated for this data element",
"items":{
"$ref":"#/components/schemas/ValidationRuleDto"
}
},
"clearedLabs":{
"type":"array",
"description":"List of laboratory properties associated with the data element",
"items":{
"$ref":"#/components/schemas/DCPropertyDto"
}
},
"clearedChildDataElements":{
"type":"array",
"description":"List of cleared child data elements",
"items":{
"$ref":"#/components/schemas/DataElementDto123"
}
},
"dataEventType":{
"type":"string",
"description":"Event type indicating data change lifecycle.",
"example":"FORM_RESTORED"
},
"affidavitCodeValue":{
"type":"string",
"description":"Affidavit code value when affidavit applies",
"example":"Electronic Signature Affidavit"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Locked timestamp for visit start date",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"Data element with document linkage, validation rules, cleared labs and child elements, and visit start date lock metadata."
},
"DataElementFormAssociationsReq3":{
"type":"object",
"properties":{
"formsAssociations":{
"type":"array",
"description":"List of form associations for the provided data elements.",
"example":[
],
"items":{
"$ref":"#/components/schemas/FormAssociationsDataElmntsReqDto21"
}
},
"context":{
"$ref":"#/components/schemas/Context3"
},
"dataElements":{
"type":"array",
"description":"List of data elements for the request.",
"example":[
],
"items":{
"$ref":"#/components/schemas/CoreDataElementV7"
}
}
},
"description":"Request including context, data elements and associated forms."
},
"SubjectVisitsDto100":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique subject identifier representing the participant enrolled in the study",
"example":"AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA"
},
"visits":{
"type":"array",
"description":"List of visit status records for the subject",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto12"
}
},
"scheduledVisits":{
"type":"array",
"description":"List of scheduled visits with scheduling windows",
"items":{
"$ref":"#/components/schemas/ScheduledVisitsDto"
}
},
"crntStateStudyVrsn":{
"type":"string",
"description":"String representing the version of the study configuration or protocol. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"signedStatus":{
"type":"string",
"description":"Subject-level signed status aggregated across visits",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Subject-level verified status aggregated across visits",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Subject-level freeze status aggregated across visits",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp of the last sign action for the subject",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"lockedStatus":{
"type":"string",
"description":"Subject-level locked status",
"example":"LOCKED"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if subject can be completed based on current data and rules",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked, if applicable",
"example":"3.0.0.1"
},
"ehrLinkStatus":{
"type":"number"
},
"withdrawalDate":{
"type":"string",
"format":"date-time"
},
"studyCompletionDate":{
"type":"string",
"format":"date-time"
}
}
},
"DcsResponseSubjectVisitsStatusResponse100":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse100"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectVisitsStatusResponse100":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto100"
}
}
}
},
"DcsResponseSubjectVisitsStatusResponse110":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse110"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectVisitsDto110":{
"type":"object",
"properties":{
"subjectId":{
"type":"string"
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto12"
}
},
"scheduledVisits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ScheduledVisitsDto20"
}
},
"crntStateStudyVrsn":{
"type":"string"
},
"signedStatus":{
"type":"string"
},
"verifiedStatus":{
"type":"string"
},
"freezedStatus":{
"type":"string"
},
"lastSigned":{
"type":"string"
},
"lockedStatus":{
"type":"string"
},
"canBeCompleted":{
"type":"boolean"
},
"lockedInStudyVersion":{
"type":"string"
},
"ehrLinkStatus":{
"type":"number"
},
"withdrawalDate":{
"type":"string",
"format":"date-time"
},
"studyCompletionDate":{
"type":"string",
"format":"date-time"
}
}
},
"SubjectVisitsStatusResponse110":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto110"
}
}
}
},
"SubjectVisitsDto12":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"visits":{
"type":"array",
"description":"Visit statuses for the subject",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto14"
}
},
"scheduledVisits":{
"type":"array",
"description":"Scheduled visits derived for the subject",
"items":{
"$ref":"#/components/schemas/ScheduledVisitsDto20"
}
},
"crntStateStudyVrsn":{
"type":"string",
"description":"Current state study version in which the subject resides",
"example":"3.0.0.1"
},
"signedStatus":{
"type":"string",
"description":"Signed status of the subject. Acceptable Values are - SIGNED, NEVER_SIGNED, NOT_APPLICABLE",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status of the subject. Acceptable Values are - VERIFIED, NEVER_VERIFIED, NOT_APPLICABLE",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the subject. Acceptable Values are - FROZEN, NEVER_FROZEN, NOT_APPLICABLE",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the subject. Acceptable Values are - LOCKED, NEVER_LOCKED, NOT_APPLICABLE",
"example":"LOCKED"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if all required data is present to mark subject as completed",
"example":true
},
"canBeReplaced":{
"type":"boolean",
"description":"Indicates if subject randomization can be replaced",
"example":false
},
"canBeUndoWithdrawn":{
"type":"boolean",
"description":"Indicates if subject withdrawal can be undone",
"example":false
},
"replaceRand":{
"type":"string",
"description":"Randomization replacement state or action",
"example":"REPLACE_ALLOWED"
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study design version in which the subject is locked",
"example":"3.0.0.1"
},
"ehrLinkStatus":{
"type":"number",
"description":"Status code indicating EHR link state",
"format":"int32",
"example":1
},
"withdrawalDate":{
"type":"string",
"description":"Subject withdrawal date",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Subject study completion date",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"List of subject visit status entries"
},
"SubjectVisitsStatusResponse12":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subject visit status entries",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto12"
}
}
},
"description":"Response wrapper containing the list of subject visit status entries for the requested study and mode"
},
"DcsResponseSubjectVisitsStatusResponse12":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse12"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectVisitsDto13":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"visits":{
"type":"array",
"description":"Visit statuses for the subject",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto15"
}
},
"scheduledVisits":{
"type":"array",
"description":"Scheduled visits derived for the subject",
"items":{
"$ref":"#/components/schemas/ScheduledVisitsDto20"
}
},
"crntStateStudyVrsn":{
"type":"string",
"description":"Current state study version in which the subject resides",
"example":"3.0.0.1"
},
"signedStatus":{
"type":"string",
"description":"Signed status of the subject. Acceptable values are - SIGNED, NEVER_SIGNED, NOT_APPLICABLE",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status of the subject. Acceptable values are - VERIFIED, NEVER_VERIFIED, NOT_APPLICABLE",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the subject.Acceptable values are - FROZEN, NEVER_FROZEN, NOT_APPLICABLE",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the subject.Acceptable values are - LOCKED, NEVER_LOCKED, NOT_APPLICABLE",
"example":"LOCKED"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if all required data is present to mark subject as completed",
"example":true
},
"canBeReplaced":{
"type":"boolean",
"description":"Indicates if subject randomization can be replaced",
"example":false
},
"canBeUndoWithdrawn":{
"type":"boolean",
"description":"Indicates if subject withdrawal can be undone",
"example":false
},
"replaceRand":{
"type":"string",
"description":"Randomization replacement state or action. Acceptable Values are - Y or N",
"example":"Y"
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study design version in which the subject is locked",
"example":"3.0.0.1"
},
"ehrLinkStatus":{
"type":"number",
"description":"Status code indicating EHR link state",
"format":"int32",
"example":1
},
"withdrawalDate":{
"type":"string",
"description":"Subject withdrawal date",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Subject study completion date",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
}
},
"description":"List of subject visit status entries"
},
"SubjectVisitsStatusResponse13":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"description":"List of subject visit status entries",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto13"
}
}
},
"description":"Response wrapper containing the list of subject visit status entries for the requested study and mode"
},
"VisitsStatusDto15":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Locked status for the visit start date.Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
},
"doseHoldAction":{
"type":"string",
"description":"Dose hold action for the visit. The acceptable values are ENABLE or DISABLE",
"example":"ENABLE"
},
"designStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries associated with this visit",
"format":"int32",
"example":0
}
},
"description":"Visit statuses for the subject"
},
"DcsResponseSubjectVisitsStatusResponse13":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse13"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"CodedDerrivedItemsResponse2":{
"type":"object",
"properties":{
"source_propertyId":{
"type":"string",
"description":"Source property Unique identifier(UUID, 32-character uppercase hexadecimal string). Must be unique per data context.",
"example":"C2D20B70E856463EBC6C830C693D1B40"
},
"source_value":{
"type":"string",
"description":"Original value from the source that is being coded.",
"example":"ALT"
},
"coding_context":{
"type":"string",
"description":"Context in which the coding is performed.",
"example":"{\"Route of Administration\":\"as\",\"Indication\":\"fer\"}"
},
"codeValuesList":{
"type":"object",
"properties":{
"coding_info_id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding info used to derive the code.",
"example":"3A1A5E8B0F894A9CA9F324D04B162F23"
},
"dataElement":{
"$ref":"#/components/schemas/DataElementDto"
},
"source_propertyId":{
"type":"string",
"description":"Source property Unique identifier(UUID, 32-character uppercase hexadecimal string). Must be unique per data context.",
"format":"UUID",
"example":"C2D20B70E856463EBC6C830C693D1B40"
},
"source_value":{
"type":"string",
"description":"Original value from the source that is being coded.",
"example":"ALT"
}
},
"description":"Represents a coded item in a data element response, including identifiers, source value, and a referenced DataElement object."
}
},
"description":"Response object for returning coded derived items. Includes original identifiers, context and coded result items."
},
"CodedDerrivedItemsRequest2":{
"required":[
"coding_context",
"source_value"
],
"type":"object",
"properties":{
"source_propertyId":{
"type":"string",
"description":"Source property Unique identifier(UUID, 32-character uppercase hexadecimal string). Must be unique per data context.",
"example":"C2D20B70E856463EBC6C830C693D1B40"
},
"source_value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Original value from the source that is being coded.",
"example":"ALT"
},
"coding_context":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Context in which the coding is performed.",
"example":"{\"Route of Administration\":\"as\",\"Indication\":\"fer\"}"
},
"codeValuesList":{
"required":[
"code_value"
],
"type":"object",
"properties":{
"coding_info_id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding info used to derive the code.",
"example":"3A1A5E8B0F894A9CA9F324D04B162F23"
},
"item_id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"5B3B7E0ED4F24E30B5A3A44C5A896C90"
},
"target_id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding result target.",
"example":"F843B5478028498882E3AF11FEBA3F2A"
},
"code_value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"The actual code value derived from the coding process.",
"example":"R79.0"
}
},
"description":"Represents a coded value applied to a source value. Includes coding information, item and target identifiers and the coded result."
}
},
"description":"Request object for inserting or updating coded derived items. Contains the source property ID, source value, coding context, and a list of code values."
},
"ChildItemDto2":{
"type":"object",
"properties":{
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"type":{
"type":"string",
"description":"Type/category of the child item (e.g., Question, Section)",
"example":"Question"
},
"title":{
"type":"string",
"description":"Display title of the child item",
"example":"Height"
},
"branchVisit":{
"type":"boolean",
"description":"Indicates if the item belongs to a branch visit",
"example":false
},
"visitTitle":{
"type":"string",
"description":"Title of the visit containing this item",
"example":"Screening"
},
"inFuture":{
"type":"boolean",
"description":"Whether the item belongs to a future visit instance",
"example":false
},
"isHidden":{
"type":"boolean",
"description":"Whether the item is hidden by rule or configuration",
"example":false
},
"isReadOnly":{
"type":"boolean",
"description":"Whether the item is read-only",
"example":false
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
}
},
"description":"Extended child item metadata with event instance number"
},
"DataElementDto20":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
}
},
"description":"Data element extension adding object version number for optimistic locking"
},
"DataElementDto100":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the data element. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED",
"example":"NEVER_LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the current lock status became effective",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int64",
"example":2
}
},
"description":"Data element including lock metadata and repeat form number"
},
"DataElementDto10":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"formStatus":{
"type":"string",
"enum":[
"NOT_STARTED",
"COMPLETED",
"COMPLETED_WITH_ERROR",
"IN_PROGRESS",
"INCOMPLETE_WITH_ERROR",
"INCOMPLETE",
"REMOVED"
]
}
}
},
"DataElementsFormAssociationsDto2":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements",
"items":{
"$ref":"#/components/schemas/DataElementDto11"
}
},
"formsAssociations":{
"type":"array",
"description":"List of form associations",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto"
}
}
},
"description":"Aggregated data elements and form associations"
},
"FormsAssociationsHistoryDto2":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the association record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"srcEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"srcEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"srcFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"srcRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"srcStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"associatedEventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"93CC828113AC439181071CB44D2C6FE5"
},
"associatedEventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"associatedFormId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"AA11BB22CC33DD44EE55FF6677889900"
},
"associatedRepeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"associatedStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.2"
},
"reason":{
"type":"string",
"description":"Reason",
"example":"Association created"
},
"comment":{
"type":"string",
"description":"Comment",
"example":"Linked forms across events"
},
"srcItemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"User identifier (UUID) who created or modified the association",
"example":"9F8E7D6C5B4A3A2B1C0D9E8F7A6B5C4D"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-01T10:00:00Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"srcFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"associatedFormSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"C6E0C7D5A1F3428C8B8B6A77C5E9D4AB"
},
"srcRepeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
},
"associatedRepeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
}
},
"description":"Extends FormsAssociationsHistoryDto with version end timestamp, software version number and section linkage details for source and associated forms including repeat form numbers."
},
"DataElementDetails20":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"BBCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"repeatTwoSectionFormNumber":{
"type":"integer",
"description":"Repeat section form number, if applicable.",
"format":"int32",
"example":1
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"50DB4EF4847849CCB24EFCCB71CDA436"
}
},
"description":"Data element details (v2) including two-section form repeat number and form section identifier."
},
"MultipleDataElementsRequestDto20":{
"type":"object",
"properties":{
"dataElementDetails":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDetails20"
}
}
}
},
"LabAssociationFormDto":{
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"formRepeats":{
"type":"array",
"description":"List of lab association repeat mappings",
"items":{
"$ref":"#/components/schemas/LabAssociationRepeatingDto"
}
}
},
"description":"Lab association details for a specific form, including repeat mappings"
},
"LabAssociationRepeatingDto":{
"type":"object",
"properties":{
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":1
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"labId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the lab normals record. Include for update requests; omit for new create.",
"example":"0123456789ABCDEF0123456789ABCDEF"
}
},
"description":"Lab association mapping for a repeating form instance"
},
"LabAssociationsDto":{
"type":"object",
"properties":{
"forms":{
"type":"array",
"description":"List of lab association forms",
"items":{
"$ref":"#/components/schemas/LabAssociationFormDto"
}
}
},
"description":"Container for lab association details grouped by forms"
},
"VisitDataDto20":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDto121"
}
},
"formsAssociations":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
},
"forms":{
"type":"array",
"items":{
"$ref":"#/components/schemas/FormLockDto10"
}
},
"visit":{
"$ref":"#/components/schemas/VisitLockDto"
},
"labAssociations":{
"$ref":"#/components/schemas/LabAssociationsDto"
}
}
},
"DataElementRequest20":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto20"
}
}
},
"DataElementsFormAssociationsDto3":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements",
"items":{
"$ref":"#/components/schemas/DataElementDto12"
}
},
"formsAssociations":{
"type":"array",
"description":"List of form associations",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto"
}
}
},
"description":"Aggregated data elements and form associations"
},
"DcsResponseDataElementsFormAssociationsDto3":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/DataElementsFormAssociationsDto3"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElementRepeatingFormsReq2":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context"
},
"repeatingForms":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RepeatingFormsDataElementReqDto2"
}
}
}
},
"RepeatingFormsDataElementReqDto2":{
"type":"object",
"properties":{
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"dataElements":{
"type":"array",
"description":"List of core data elements for this form instance",
"items":{
"$ref":"#/components/schemas/CoreDataElementV4"
}
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
}
},
"description":"Extends RepeatingFormsDataElementReqDto with repeat form number."
},
"FormAssociationsUpdateDto2":{
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Change for encoding"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Updated association details"
},
"formsAssociations":{
"type":"array",
"description":"List of form association updates to apply",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
}
},
"description":"Payload to update form associations for a given form context"
},
"FormAssociationsUpdateRespDto2":{
"type":"object",
"properties":{
"formsAssociations":{
"type":"array",
"description":"List of form associations",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
}
},
"description":"Form associations update response (v2)"
},
"DcsResponseFormAssociationsUpdateRespDto2":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/FormAssociationsUpdateRespDto2"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SignVerifyFreezeDTOv30":{
"type":"object",
"properties":{
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0C50E26E482246B2BB9646C739E97CAA"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the Sign/Verify/Freeze record in UUID format",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-02T17:30:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2C3F40649C654D0F995A7FDBBCEA4FAB"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":100
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"reason to make this change",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments if provided",
"example":"Data discrepancy observed and clarified"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"C39E34A9152148E0BB831239BAA3E502"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"signed":{
"type":"string",
"description":"Signed status can be of SIGNED, UNSIGNED, NEVER_SIGNED, PARTIAL_SIGNED ",
"example":"2C3F40649C654D0F995A7FDBBCEA4FAB"
},
"verify":{
"type":"string",
"description":"Verify status can be UNVERIFIED, VERIFIED, NEVER_VERIFIED, VERIFY_REQUIRED",
"example":"VERIFIED"
},
"freeze":{
"type":"string",
"description":"Freeze status can be of FROZEN, UNFROZEN, NEVER_FROZEN",
"example":"FROZEN"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int64",
"example":0
}
},
"description":"Extends v20 by adding form section identifier and repeat form number for repeating forms."
},
"VisitsStatusDto2":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
}
},
"description":"Visit status details including visit type and event type"
},
"SubjectVisitsDto20":{
"type":"object",
"properties":{
"subjectId":{
"type":"string"
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto2"
}
},
"crntStateStudyVrsn":{
"type":"string"
}
}
},
"ClearDataResponseDto20":{
"type":"object",
"properties":{
"clearedData":{
"type":"array",
"description":"List of cleared data details",
"items":{
"$ref":"#/components/schemas/ClearedDataDto20"
}
}
},
"description":"Response wrapper containing cleared data details"
},
"ClearedDataDto20":{
"type":"object",
"properties":{
"visits":{
"$ref":"#/components/schemas/Visits"
},
"dataElements":{
"type":"array",
"description":"List of cleared data elements",
"items":{
"$ref":"#/components/schemas/DataElementDto131"
}
},
"labs":{
"type":"array",
"description":"List of cleared lab property details",
"items":{
"$ref":"#/components/schemas/DCPropertyDto"
}
}
},
"description":"Container for cleared data including visit details, cleared data elements, and lab property IDs"
},
"DataElementDto120":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
}
},
"description":"Data element details including form status information for the associated form."
},
"DataElementDto122":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"parentId":{
"type":"string",
"description":"Identifier (UUID, 32-character uppercase hexadecimal string) of the parent data element in uppercase hex.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"rootId":{
"type":"string",
"description":"Identifier of root data element in UUID, 32-character uppercase hexadecimal string.",
"format":"UUID",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"LOCK"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the data element version",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"itemType":{
"type":"string",
"description":"Type of item represented by this data element",
"example":"TEXT"
},
"itemD":{
"type":"string",
"description":"The decoded value of the raw value, which provides a more meaningful representation of the data. For dates, it follows the ISO 8601 standard. For questions with multiple choice options, it uses the corresponding code from the codelist. Additionally, ItemD decodes special flags like NA, ND, and UNK to their corresponding meanings, making it easier to understand the data.",
"example":"DETAIL"
},
"itemF":{
"type":"string",
"description":"The formatted value that matches the data type of the question, such as a date in a specific format or a number with correct decimal places. If the user didn't provide a valid response, ItemF will be null.",
"example":"FLAG"
},
"itemR":{
"type":"string",
"description":"The raw value entered by the user, which can be a text, number, or date, and is stored as alphanumeric data. It may also contain special flags such as NA (Not Applicable), ND (Not Done), UNK (Unknown), or Not Answered if the user didn't provide a response.",
"example":"REASON"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":2
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the data element was captured in the source system",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the data element. Acceptable Values are LOCKED, NOT_APPLICABLE",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the data element was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"93CC828113AC439181071CB44D2C6FE5"
}
},
"description":"List of data elements for the visit."
},
"VisitDataDto30":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements for the visit.",
"items":{
"$ref":"#/components/schemas/DataElementDto122"
}
},
"formsAssociations":{
"type":"array",
"description":"List of form associations for the visit.",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
},
"forms":{
"type":"array",
"description":"List of forms for the visit.",
"items":{
"$ref":"#/components/schemas/FormLockDto10"
}
},
"labAssociations":{
"$ref":"#/components/schemas/LabAssociationsDto"
},
"visit":{
"$ref":"#/components/schemas/VisitLockDto"
}
},
"description":"Visit-level data including data elements, forms, and lock information."
},
"DataElementRequest30":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto30"
}
}
},
"DataElementRepeatingFormsReq3":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context"
},
"repeatingForms":{
"type":"array",
"description":"List of repeating form requests containing data elements for each repeat instance.",
"items":{
"$ref":"#/components/schemas/RepeatingFormsDataElementReqDto3"
}
}
},
"description":"Request payload containing context and repeating form data elements."
},
"RepeatingFormsDataElementReqDto3":{
"type":"object",
"properties":{
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"dataElements":{
"type":"array",
"description":"List of core data elements for this form instance",
"items":{
"$ref":"#/components/schemas/CoreDataElementV4"
}
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
}
},
"description":"Extends RepeatingFormsDataElementReqDto2 with inner and outer repeat indices."
},
"LabRequestDto20":{
"required":[
"eventId",
"formId",
"siteId",
"studyVersion",
"subjectId"
],
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A1B2C3D4E5F6471890ABCDEF12345678"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"799EF3745FC545589F186D2198F3C65E"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"899EF3745FC545589F186D2198F3C65E"
},
"labId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the lab normals record. Include for update requests; omit for new create.",
"example":"999EF3745FC545589F186D2198F3C65E"
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
}
}
},
"SubjectDto_30":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when this subject was updated/imported",
"format":"date-time",
"example":"2025-12-05T12:12:35Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Subject details for version 3.0, including all past event and version fields and the source timestamp when an external system submitted the subject"
},
"ReasonCommentRequest20":{
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Incorrect entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Removing incorrect data captured by mistake"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp for the code break request (ISO 8601 format, UTC).",
"format":"date-time",
"example":"2025-11-06T12:45:00Z"
}
},
"description":"Request payload providing a reason, optional comment, and a timestamp for code break."
},
"SubjectDto9":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Subject attributes including source system timestamp metadata"
},
"VisitResult":{
"title":"VisitResult",
"type":"object",
"properties":{
"randomNumber":{
"title":"Random Number",
"type":"string",
"description":"Random number.",
"example":"10"
},
"kits":{
"title":"Kits",
"type":"array",
"description":"Contains information for the kit dispensation.",
"items":{
"$ref":"#/components/schemas/DispensationKit"
}
},
"visitTimestamp":{
"title":"Visit Timestamp",
"type":"string",
"description":"Visit timestamp.",
"format":"date-time"
},
"treatmentTitle":{
"title":"Treatment Title",
"type":"string",
"description":"Treatment title.",
"example":"A"
},
"needsToVisitPharmacist":{
"title":"Needs To Visit Pharmacist",
"type":"boolean",
"description":"Indicates whether the subject needs to visit an unblinded pharmacist for kit dispensation.",
"example":true
},
"countOfKitTypesOnDoseHold":{
"title":"Count Of Kit Types On Dose Hold",
"type":"integer",
"description":"Number of kit types on dose hold.",
"format":"int32",
"example":1
},
"pendingKitQuantity":{
"title":"Pending Kit Quantity",
"type":"integer",
"description":"Number of kits pending dispensation.",
"format":"int32",
"example":1
},
"forcedRandomized":{
"title":"Forced Randomized",
"type":"boolean",
"description":"Indicates whether the subject was forced randomized.",
"example":true
}
},
"description":"Visit result."
},
"SubjectMigrationResponseDTO2":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":9
},
"eventType":{
"type":"string",
"description":"Event type name tracked for subject migration",
"example":"MIGRATED"
},
"subjectTransferId":{
"type":"string",
"description":"UUID of subject transfer record (if subject was transferred)",
"example":"1234567890ABCDEF1234567890ABCDEF"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned post migration.",
"example":"RND-123"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the subject was migrated or synchronized",
"format":"date-time",
"example":"2025-12-01T10:30:51Z"
}
},
"description":"Response payload for subject migration, including audit trail, object/version, subject event and randomization number"
},
"SubjectMigrationRequest2":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectMigrationRequestDTO2"
}
}
},
"SubjectMigrationRequestDTO2":{
"required":[
"state",
"subjectNumber"
],
"type":"object",
"properties":{
"randomizationNumber":{
"type":"string",
"description":"Randomization number for the subject at migration",
"example":"RND-123"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0301"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AABBCCDDEEFF1234567890ABCDEF1234"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed.",
"example":"Active"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp when the migration was triggered/sourced",
"format":"date-time",
"example":"2025-12-01T09:50:00Z"
}
},
"description":"Details for subject migration, including randomization number, subject identifiers, site, status, and timestamps"
},
"SubjectTransferDto3":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the subject being transferred.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred from.",
"example":"938D23FA6B7241CCA41BD627E5DB60DA"
},
"toSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred to.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the subject transfer.",
"example":"Site change"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment or note about the subject transfer.",
"example":"Moved subject to new site"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":8
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"3099-12-31T00:00:00Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the subject transfer record.",
"example":"A1B2C3D4E5F64789AABBCCDDEEFF1122"
},
"versionStart":{
"type":"string",
"description":"Timestamp representing the start of the version for this subject transfer record.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"newSubjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"New subject number after transfer or renumbering.",
"example":"SUBJ-0001-NEW"
}
},
"description":"Represents a subject transfer between sites used for API rresponse bodies including version end."
},
"VisitsStatusDto3":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
}
},
"description":"Visit status details including object version number for optimistic locking"
},
"ClearDataResponseDto30":{
"type":"object",
"properties":{
"clearedData":{
"type":"array",
"description":"List of cleared data entries",
"items":{
"$ref":"#/components/schemas/ClearedDataDto30"
}
}
},
"description":"Clear data response DTO"
},
"ClearedDataDto30":{
"type":"object",
"properties":{
"visits":{
"$ref":"#/components/schemas/Visits"
},
"dataElements":{
"type":"array",
"description":"List of cleared data elements",
"items":{
"$ref":"#/components/schemas/DataElementDto136"
}
},
"labs":{
"type":"array",
"description":"List of lab properties",
"items":{
"$ref":"#/components/schemas/DCPropertyDto"
}
},
"formsStatus":{
"type":"array",
"description":"List of form statuses",
"items":{
"$ref":"#/components/schemas/FormsStatusResponseDto"
}
}
},
"description":"Cleared data details"
},
"DataElementListFormStatusesDto":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements captured/updated",
"items":{
"$ref":"#/components/schemas/DataElementDto123"
}
},
"formsStatus":{
"type":"array",
"description":"List of form status entries with repeat hierarchy",
"items":{
"$ref":"#/components/schemas/FormsStatusResponseDto"
}
}
},
"description":"Response wrapper containing data elements and their corresponding form statuses."
},
"DataElementDto60":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
}
},
"description":"Data element sign/verify/freeze status fields inherited by higher versions"
},
"MultipleDataElementsRequestDto30":{
"type":"object",
"properties":{
"dataElementDetails":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDetails30"
}
}
}
},
"VisitDataDto4":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements captured for the visit",
"items":{
"$ref":"#/components/schemas/DataElementDto123"
}
},
"formsAssociations":{
"type":"array",
"description":"List of form associations for the visit",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
},
"forms":{
"type":"array",
"description":"List of form lock details for the visit",
"items":{
"$ref":"#/components/schemas/FormLockDto10"
}
},
"labAssociations":{
"$ref":"#/components/schemas/LabAssociationsDto"
},
"visit":{
"$ref":"#/components/schemas/VisitLockDto"
},
"formsStatus":{
"type":"array",
"description":"List of form statuses for the visit",
"items":{
"$ref":"#/components/schemas/FormsStatusResponseDto"
}
}
},
"description":"Visit-level data including data elements, forms associations, lock details, lab associations, and form statuses."
},
"DcsResponseVisitDataDto4":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/VisitDataDto4"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElementDto40":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
}
},
"description":"Data element properties including targeting metadata, extending v3 with targets list"
},
"DataElementsRequestDto2":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context2"
},
"dataElements":{
"type":"array",
"items":{
"$ref":"#/components/schemas/CoreDataElement"
}
}
}
},
"CoreDataElementV50":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Primary uuid identifier for the data element instance (HEX, upper case).",
"example":"C1234567C1234567C1234567C1234567"
},
"transactionStart":{
"type":"string",
"description":"Transaction start date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T12:00:00Z"
},
"transactionEnd":{
"type":"string",
"description":"Transaction end date/time for this observation.",
"format":"date-time",
"example":"2024-01-01T13:00:00Z"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D9876543D9876543D9876543D9876543"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":2
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"example":"E5554444E5554444E5554444E5554444"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"example":"F4443333F4443333F4443333F4443333"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Code supplied by vendor.",
"example":"VENDOR42"
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Measured value captured for this data element.",
"example":"42.0"
},
"measureUnit":{
"type":"string",
"description":"Unit of measurement for this value (if applicable).",
"example":"mg/dL"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for this data entry/edit.",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Any general comments for the data element instance.",
"example":"Measured after fasting"
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"propertyId":{
"type":"string",
"description":"Unique Identfier (UUID, 32-character uppercase hexadecimal string) of data capture properties",
"example":"299BC76CF0F943E6BAC1D209BC3D1CDC"
},
"propertyVersionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2024-01-01T00:00:00Z"
},
"hdiId":{
"type":"string",
"description":"Stores the ID as received from Oracle Clinical Conector (OCC). It could be different for each data element in a form, but can also be the same. Uses UUID, 32-character uppercase hexadecimal string format.",
"example":"A86F2D0BB610404DB62D37AFA9C20B50"
},
"documentId":{
"type":"string",
"description":"Unique identifier of the associated source document (hex UUID, 32-character uppercase), enabling traceability between the data element and its original supporting document or file.",
"format":"uuid"
},
"documentVersion":{
"type":"number",
"description":"Version of the source or supporting document linked to this data element.",
"example":1
}
},
"description":"Core data element payload with optional document linkage information"
},
"DataElementRepeatingFormsReq4":{
"type":"object",
"properties":{
"context":{
"$ref":"#/components/schemas/Context"
},
"repeatingForms":{
"type":"array",
"description":"List of repeating form payloads with their repeat numbers and data elements",
"items":{
"$ref":"#/components/schemas/RepeatingFormsDataElementReqDto10"
}
}
},
"description":"Request to save multiple data elements for repeating forms within a context"
},
"RepeatingFormsDataElementReqDto10":{
"type":"object",
"properties":{
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"example":1
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"example":1
},
"dataElements":{
"type":"array",
"description":"List of core data element values to store for this repeating form instance",
"items":{
"$ref":"#/components/schemas/CoreDataElementV50"
}
}
},
"description":"Payload for a single repeating form instance with its repeat numbers and data elements"
},
"DcsResponseDataElementListFormStatusesDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/DataElementListFormStatusesDto"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SignDTO":{
"type":"object",
"properties":{
"signLevel":{
"type":"string",
"description":"Level at which signature is required. Typical values: SUBJECT_LEVEL, FORM_LEVEL.",
"example":"SUBJECT_LEVEL"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"3234E620DE2E41D69A36571064E727B2"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"configId":{
"type":"string",
"description":"Signature configuration identifier (UUID, 32-character uppercase hexadecimal string).",
"example":"F9E5DBD829B34E298CB6FF4ED60DC927"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":0
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"7DB612AF851A442098B674AA1A97AF36"
}
},
"description":"Details for a single sign request for the subject signature API."
},
"SignRequestDto":{
"required":[
"signRequest"
],
"type":"object",
"properties":{
"signRequest":{
"$ref":"#/components/schemas/SignDTO"
}
},
"description":"Request body for subject signature. Contains a list of signatures to process."
},
"SubjectDto40":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp for the code break (ISO 8601 format, UTC).",
"format":"date-time",
"example":"2025-11-06T12:45:00Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
}
},
"SubjectDto13":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Indicates the number of screened subject ",
"example":"SCR-0001"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-0001"
},
"mrnNumber":{
"type":"string",
"description":"Medical record number of subject",
"example":"mrn-0001"
},
"withdrawalDate":{
"type":"string",
"description":"withdrawl Date of subject",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date at which clinical study completed",
"example":"2025-10-16T14:30:31.892Z"
},
"withdrawalReason":{
"type":"string",
"description":"Reason to withdraw subject",
"example":"not suitable"
},
"withdrawalComment":{
"type":"string",
"description":"Comment to withdraw subject",
"example":"Subject fails in trial"
},
"screenFailureComment":{
"type":"string",
"description":"Comment to make Subject fail in screening",
"example":"screeing failure"
}
},
"description":"Subject properties indicating Screening Number"
},
"SubjectRequest50":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectDto13"
}
}
},
"DispensationKitV12":{
"title":"DispensationKit v12.0",
"type":"object",
"properties":{
"id":{
"title":"Dispensation Kit ID",
"type":"number",
"description":"Unique identifier of the dispensation kit.",
"format":"Integer",
"example":2
},
"kitDescription":{
"title":"Kit Description",
"type":"string",
"description":"Kit description.",
"example":"Kit A"
},
"dose":{
"title":"Dose",
"type":"number",
"description":"Dose.",
"format":"double",
"example":5
},
"measurement":{
"title":"Measurement",
"type":"string",
"description":"Dose Measurement.",
"example":"ml"
},
"frequency":{
"title":"Frequency",
"type":"string",
"description":"Dosing frequency.",
"example":"BID",
"enum":[
"Once",
"QD",
"BID",
"TID",
"QID",
"Q3",
"Q4",
"Q8",
"Q12",
"Q24",
"Bedtime",
"With meals",
"With meals and at bedtime"
]
},
"consumeAcrossDoses":{
"title":"Consume Across Doses",
"type":"boolean",
"description":"Indicates whether consumption across doses is allowed.",
"example":true
},
"deviceType":{
"title":"Device Type",
"type":"string",
"description":"Device type.",
"example":"ActivityWatch",
"enum":[
"ActivityWatch",
"BloodPressureMonitor",
"WeightScale",
"ECGReader",
"Spirometer",
"MobileApp",
"SmartPillBottle",
"PulseOximeter",
"WearablePatch",
"Other",
"GlucoseMonitor"
]
},
"deviceConnection":{
"title":"Device Connection Type",
"type":"string",
"description":"Device connection type.",
"example":"DevicetoCloud",
"enum":[
"CloudtoCloud",
"DevicetoCloud",
"NoConnection"
]
},
"inventoryId":{
"title":"Inventory ID",
"type":"string",
"description":"Inventory ID.",
"example":"D313327EF13845169A8ADADDA435431E"
},
"trialSupplyType":{
"title":"Trial Supply Type",
"type":"string",
"description":"Type of the trial supply.",
"example":"BOTTLE"
},
"conserved":{
"title":"Conserved",
"type":"boolean",
"description":"Conserved for dispensation.",
"example":true
},
"titrationKitLabel":{
"title":"Blinded Titration Label",
"type":"string",
"description":"Blinded titration label.",
"example":"High dose"
},
"barcode":{
"type":"string",
"description":"Barcode.",
"example":"1000"
},
"dispensationConfirmed":{
"type":"boolean",
"description":"Indicates whether dispensation is confirmed.",
"example":true
},
"groupingNumber":{
"title":"Grouping Number",
"type":"integer",
"description":"Grouping number for a kit.",
"format":"int32",
"example":1
},
"kitNumberUTF":{
"title":"Kit Number UTF",
"type":"string",
"description":"Kit number with UTF-8 support.",
"example":"A-1"
},
"dosingUnblinded":{
"title":"Dosing Unblinded",
"type":"boolean",
"description":"Indicates whether dosing is unblinded.",
"example":true
},
"titrationOption":{
"title":"Titration Option",
"type":"string",
"description":"Titration options to dispense kits. For example: up/down/maintain.",
"example":"up",
"enum":[
"up",
"down",
"maintain"
]
},
"locallySourced":{
"title":"Locally Sourced",
"type":"boolean",
"description":"Indicates whether the kit is locally sourced.",
"example":true
},
"quantity":{
"title":"Quantity",
"type":"number",
"description":"Kit quantity.",
"format":"BigDecimal",
"example":5
},
"lotId":{
"title":"Lot ID",
"type":"string",
"description":"Lot ID.",
"example":"D313327EF13845169A8ADADDA435431E"
},
"lotNumber":{
"title":"Lot Number",
"type":"string",
"description":"Lot number.",
"example":"LOT20240605A"
}
},
"description":"Contains information for the kit dispensation."
},
"VisitResultV15":{
"title":"VisitResult v15.0",
"type":"object",
"properties":{
"randomNumber":{
"title":"Random Number",
"type":"string",
"description":"Random number.",
"example":"10"
},
"kits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationKitV12"
}
},
"visitTimestamp":{
"title":"Visit Timestamp",
"type":"string",
"description":"Visit timestamp.",
"format":"date-time"
},
"treatmentTitle":{
"title":"Treatment Title",
"type":"string",
"description":"Treatment title.",
"example":"A"
},
"needsToVisitPharmacist":{
"title":"Needs To Visit Pharmacist",
"type":"boolean",
"description":"Indicates whether the subject needs to visit an unblinded pharmacist for kit dispensation.",
"example":true
},
"countOfKitTypesOnDoseHold":{
"title":"Count Of Kit Types On Dose Hold",
"type":"integer",
"description":"Number of kit types on dose hold.",
"format":"int32",
"example":1
},
"pendingKitQuantity":{
"title":"Pending Kit Quantity",
"type":"integer",
"description":"Number of kits pending dispensation.",
"format":"int32",
"example":1
}
},
"description":"Visit result."
},
"SubjectDto10":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Subject attributes including screen failure date information"
},
"SubjectRequest40":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectDto10"
}
}
},
"SubjectVisitsDto40":{
"type":"object",
"properties":{
"subjectId":{
"type":"string"
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto5"
}
},
"crntStateStudyVrsn":{
"type":"string"
},
"signedStatus":{
"type":"string"
},
"verifiedStatus":{
"type":"string"
},
"freezedStatus":{
"type":"string"
},
"lastSigned":{
"type":"string"
}
}
},
"VisitsStatusDto5":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
}
},
"description":"Visit status including sign, verify and freeze statuses"
},
"DcsResponseVisitDataDto5":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/VisitDataDto5"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"VisitDataDto5":{
"type":"object",
"properties":{
"dataElements":{
"type":"array",
"description":"List of data elements captured for the visit",
"items":{
"$ref":"#/components/schemas/DataElementDto123"
}
},
"formsAssociations":{
"type":"array",
"description":"List of form associations for the visit",
"items":{
"$ref":"#/components/schemas/FormsAssociationsDto2"
}
},
"forms":{
"type":"array",
"description":"List of form lock details for the visit",
"items":{
"$ref":"#/components/schemas/FormLockDto10"
}
},
"labAssociations":{
"$ref":"#/components/schemas/LabAssociationsDto"
},
"visit":{
"$ref":"#/components/schemas/VisitLockDto2"
},
"formsStatus":{
"type":"array",
"description":"List of form statuses for the visit",
"items":{
"$ref":"#/components/schemas/FormsStatusResponseDto"
}
}
}
},
"VisitLockDto2":{
"type":"object",
"properties":{
"lockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value.Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Date and time when the visit was locked.",
"format":"date-time",
"example":"2024-12-01T10:15:30Z"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Date and time when the visit start date was locked.",
"format":"date-time",
"example":"2024-12-01T10:15:30Z"
},
"visitStartDateFreezeStatus":{
"type":"string",
"description":"Freeze status of the Visit start date, applicable values are FROZEN, UNFROZEN",
"example":"UNFROZEN"
},
"visitStartDateVerifyStatus":{
"type":"string",
"description":"Verify status of the Visit start date,applicable values are UNVERIFIED, VERIFIED, VERIFY_REQUIRED",
"example":"VERIFY_REQUIRED"
},
"visitStartDateSignStatus":{
"type":"string",
"description":"Sign status of the Visit start date,applicable values are SIGNED, UNSIGNED, PARTIAL_SIGN",
"example":"PARTIAL_SIGN"
}
},
"description":"Sign, Verify and Freeze status of visit start date"
},
"DataElementRequestDto40":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto50"
}
}
},
"RandomizeDetailsV15":{
"title":"RandomizeDetails",
"type":"object",
"properties":{
"randomization":{
"$ref":"#/components/schemas/VisitResultV15"
},
"subject":{
"$ref":"#/components/schemas/SubjectDto10"
},
"visit":{
"$ref":"#/components/schemas/VisitsStatusDto13"
}
},
"description":"Contains randomization details with subject and visit summary."
},
"VisitsStatusDto13":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Locked status for the visit start date.Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
},
"doseHoldAction":{
"type":"string",
"description":"Dose hold action for the visit. The acceptable values are ENABLE or DISABLE",
"example":"ENABLE"
}
},
"description":"Visit status including window warning and dose hold action fields"
},
"VisitsStatusDto11":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
}
},
"description":"Visit status including action to be taken based on current visit state"
},
"SubjectVisitsDto50":{
"type":"object",
"properties":{
"subjectId":{
"type":"string"
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto6"
}
},
"crntStateStudyVrsn":{
"type":"string"
},
"signedStatus":{
"type":"string"
},
"verifiedStatus":{
"type":"string"
},
"freezedStatus":{
"type":"string"
},
"lastSigned":{
"type":"string"
}
}
},
"SubjectVisitsStatusResponse50":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto50"
}
}
}
},
"VisitsStatusDto6":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
}
},
"description":"Visit status including count of repeating forms captured for the visit"
},
"VisitsStatusRuleTargetsDto5":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"targets":{
"type":"array",
"description":"List of rule targets affected by this operation",
"example":[
"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC"
],
"items":{
"type":"string",
"description":"List of rule targets affected by this operation",
"example":"[\"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC\"]"
}
}
},
"description":"Visit status update response including rule targets list"
},
"RestResponseSubjectRespDto13":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectRespDto13"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectDto6":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
}
},
"description":"Subject sign, verify and freeze status fields added on top of previous subject versions"
},
"RandomizeDetailsV16":{
"title":"RandomizeDetails",
"type":"object",
"properties":{
"randomization":{
"$ref":"#/components/schemas/VisitResultV16"
},
"subject":{
"$ref":"#/components/schemas/SubjectDto10"
},
"visit":{
"$ref":"#/components/schemas/VisitsStatusDto13"
}
},
"description":"Contains randomization details with subject and visit summary."
},
"VisitResultV16":{
"title":"VisitResult v16.0",
"type":"object",
"properties":{
"randomNumber":{
"title":"Random Number",
"type":"string",
"description":"Random number.",
"example":"10"
},
"kits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DispensationKit"
}
},
"visitTimestamp":{
"title":"Visit Timestamp",
"type":"string",
"description":"Visit timestamp.",
"format":"date-time"
},
"treatmentTitle":{
"title":"Treatment Title",
"type":"string",
"description":"Treatment title.",
"example":"A"
},
"needsToVisitPharmacist":{
"title":"Needs To Visit Pharmacist",
"type":"boolean",
"description":"Indicates whether the subject needs to visit an unblinded pharmacist for kit dispensation.",
"example":true
},
"countOfKitTypesOnDoseHold":{
"title":"Count Of Kit Types On Dose Hold",
"type":"integer",
"description":"Number of kit types on dose hold.",
"format":"int32",
"example":1
},
"pendingKitQuantity":{
"title":"Pending Kit Quantity",
"type":"integer",
"description":"Number of kits pending dispensation.",
"format":"int32",
"example":1
}
},
"description":"Visit result."
},
"SubjectDto14":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"reScreenEventInstanceNum":{
"type":"string",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":"2"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Indicates the number of screened subject ",
"example":"SCR-0001"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-0001"
},
"mrnNumber":{
"type":"string",
"description":"Medical record number of subject",
"example":"mrn-0001"
},
"withdrawalDate":{
"type":"string",
"description":"withdrawl Date of subject",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date at which clinical study completed",
"example":"2025-10-16T14:30:31.892Z"
},
"withdrawalReason":{
"type":"string",
"description":"Reason to withdraw subject",
"example":"not suitable"
},
"withdrawalComment":{
"type":"string",
"description":"Comment to withdraw subject",
"example":"Subject fails in trial"
},
"screenFailureComment":{
"type":"string",
"description":"Comment to make Subject fail in screening",
"example":"screeing failure"
}
},
"description":"Contains information related to subject reScreen Event Instanc eNum"
},
"SubjectRequest60":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectDto14"
}
}
},
"VisitsStatusDto610":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp from the source system indicating when this record originated",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Visit status including repeating form counts (v5) and source timestamp"
},
"ConsolidatedRepeatInstanceResponseDto":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"CBCDEF1234567890ABCDEF1234567890"
},
"eventInstanceNumber":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"instances":{
"type":"array",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":[
"1",
"2"
],
"items":{
"type":"string",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"example":"[\"1\",\"2\"]"
}
}
},
"description":"Consolidated repeat instance numbers per form and event."
},
"DcsResponseListConsolidatedRepeatInstanceResponseDto":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ConsolidatedRepeatInstanceResponseDto"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"ConsolidatedRepeatInstanceRequestDto":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"forms":{
"type":"array",
"description":"List of form IDs for which consolidated repeat instance numbers are requested",
"example":[
"40DB4EF4847849CCB24EFCCB71CDA436",
"50DB4EF4847849CCB24EFCCB71CDA436"
],
"items":{
"type":"string",
"description":"List of form IDs for which consolidated repeat instance numbers are requested",
"example":"[\"40DB4EF4847849CCB24EFCCB71CDA436\",\"50DB4EF4847849CCB24EFCCB71CDA436\"]"
}
}
},
"description":"Request to compute consolidated repeat instance numbers across multiple forms for a subject"
},
"DcsResponseListDataElementDto10":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/DataElementDto10"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"DataElementRequestDto50":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto7"
}
}
},
"SubjectDto15":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
"example":"UNLOCKED"
},
"hasLockData":{
"type":"boolean",
"description":"Indicates whether lock related data exists for the subject",
"example":false
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the subject was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"canBeCompleted":{
"type":"boolean",
"description":"Indicates if the subject has met conditions to be completed",
"example":true
},
"lockedInStudyVersion":{
"type":"string",
"description":"Study version in which the subject is locked",
"example":"3.0.0.4"
},
"reScreenEventInstanceNum":{
"type":"string",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"example":"2"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Indicates the number of screened subject ",
"example":"SCR-0001"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-0001"
},
"mrnNumber":{
"type":"string",
"description":"Medical record number of subject",
"example":"mrn-0001"
},
"withdrawalDate":{
"type":"string",
"description":"withdrawl Date of subject",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"studyCompletionDate":{
"type":"string",
"description":"Date at which clinical study completed",
"example":"2025-10-16T14:30:31.892Z"
},
"withdrawalReason":{
"type":"string",
"description":"Reason to withdraw subject",
"example":"not suitable"
},
"withdrawalComment":{
"type":"string",
"description":"Comment to withdraw subject",
"example":"Subject fails in trial"
},
"screenFailureComment":{
"type":"string",
"description":"Comment to make Subject fail in screening",
"example":"screeing failure"
},
"enrollmentDate":{
"type":"string",
"description":"Date the subject was enrolled",
"format":"date"
}
},
"description":"Subject request/response payload including enrollmentDate and all inherited subject properties"
},
"SubjectRequest70":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectDto15"
}
}
},
"VisitsStatusDto710":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp from the source system indicating when this record originated",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action performed on visit start date LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Visit status including lock status for the visit and its start date, with corresponding lock timestamps"
},
"DataElementRequestDto60":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto8"
}
}
},
"SubjectsVisitScheduleRequestV2":{
"type":"object",
"properties":{
"sites":{
"type":"array",
"description":"List of site identifiers to scope the search",
"example":[
"D3C9A4B5E6F78123456789ABCDEF1234",
"E1F2A3B4C5D6E7F89012ABCDEF345678"
],
"items":{
"type":"string",
"description":"List of site identifiers to scope the search",
"format":"uuid"
}
},
"limit":{
"type":"integer",
"description":"Maximum number of results to return",
"format":"int32",
"example":25
},
"offset":{
"type":"integer",
"description":"Offset for pagination",
"format":"int32",
"example":0
},
"order":{
"type":"string",
"description":"Sort order for results",
"example":"asc"
},
"reviewStatus":{
"type":"string",
"description":"Review status filter applied to subjects. Values can be noopenqueries, openqueries, verified, signed, locked, allvisitscomplete, readytosign, allvisitscomplete, readytoverify, all, signedandverified, frozen ",
"example":"all"
},
"subjectStates":{
"type":"array",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed",
"example":[
"Auto_Screen_Failed"
],
"items":{
"type":"string",
"description":"States of subjects to filter by Active, New, Screening_Initiated, Enrolled, Complete, Withdrawn, ehrLinked, ehrNotLinked, Screen_Failed, Auto_Screen_Failed",
"example":"[\"Auto_Screen_Failed\"]"
}
},
"exactSearchKeywords":{
"type":"array",
"description":"Keywords for exact match in subject search which will be applied on subject number",
"example":[
"1001",
"SMITH"
],
"items":{
"type":"string",
"description":"Keywords for exact match in subject search which will be applied on subject number",
"example":"[\"1001\",\"SMITH\"]"
}
},
"containsSearchKeywords":{
"type":"array",
"description":"Keywords for contains match in subject search which will be applied on subject number",
"example":[
"100",
"SMI"
],
"items":{
"type":"string",
"description":"Keywords for contains match in subject search which will be applied on subject number",
"example":"[\"100\",\"SMI\"]"
}
},
"nextVisitOnly":{
"type":"boolean",
"description":"When true, only the next scheduled visit is returned per subject",
"example":false
},
"notStarted":{
"type":"boolean",
"description":"When true, include only subjects that have not started",
"example":false
},
"safetyCaseStatus":{
"type":"string",
"description":"Indicates the safety case status filter. values can be SUBMITTED, CREATED, MODIFIED, SUBMIT_FAILED, CANCEL_FAILED, CANCELLED, DISMISSED, ACCEPTED, REJECTED, TRANSFER_FAILED, ALL.",
"example":"ALL"
}
},
"description":"DTO for version 2 specifying filters, safety case status, and scheduling options for visits."
},
"SubjectVisitsDto70":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Subject identifier in uppercase hex format",
"example":"42CE52A1AF9A48EBABA25A361F6EC0FE"
},
"visits":{
"$ref":"#/components/schemas/VisitsStatusDto9"
},
"scheduledVisits":{
"$ref":"#/components/schemas/ScheduledVisitsDto"
},
"crntStateStudyVrsn":{
"type":"string",
"description":"Current study version under which the subject state is recorded",
"example":"1.0.0.3"
},
"signedStatus":{
"type":"string",
"description":"Signed status at the subject level, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status at the subject level, can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status at the subject level, ,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Subject visits and schedule along with current study version and sign/verify/freeze statuses"
},
"DcsResponseSubjectVisitsStatusResponse70":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse70"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectVisitsStatusResponse70":{
"type":"object",
"properties":{
"subjects":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectVisitsDto70"
}
}
}
},
"VisitsStatusDto810":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"sourceTimeStamp":{
"type":"string",
"description":"Timestamp from the source system indicating when this record originated",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"LOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action performed on visit start date LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateFreezeStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"LOCKED"
},
"visitStartDateVerifyStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFY"
},
"visitStartDateSignStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
}
}
},
"DataElementDto9":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"signedStatus":{
"type":"string",
"description":"Signature status of the data element, can have Values NOT_APPLICABLE, SIGNED",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verification status of the data element can have Values NOT_APPLICABLE, VERIFIED",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Freeze status of the data element,can have Values NOT_APPLICABLE, FROZEN",
"example":"FROZEN"
},
"propertyId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the property.",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"propertyVersionStart":{
"type":"string",
"description":"Study version start",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int32",
"example":1
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":1
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":1
}
}
},
"DataElementRequestDto70":{
"type":"object",
"properties":{
"dataElement":{
"$ref":"#/components/schemas/DataElementDto9"
}
}
},
"SubjectScreeningNumberDto":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningNumber":{
"type":"string",
"description":"Subject screening number for enrollment tracking",
"example":"SCRN-ABC-1234"
},
"randomizationNumber":{
"type":"string",
"description":"Subject randomization number for trial assignment",
"example":"RAND-XYZ-9999"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Subject DTO with screening number and randomization number, encompassing all inherited subject metadata. Includes all typical fields."
},
"SubjectsVisitScheduleDto80":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectRespDto14"
},
"visits":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"lockedStatus":{
"type":"string",
"description":"Locked status of the visit. Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Locked status for the visit start date.Can have values LOCKED,UNLOCKED or NEVER_LOCKED",
"example":"UNLOCKED"
},
"lockedDateTime":{
"type":"string",
"description":"Timestamp when the visit was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
},
"doseHoldAction":{
"type":"string",
"description":"Dose hold action for the visit. The acceptable values are ENABLE or DISABLE",
"example":"ENABLE"
},
"unResolvedQueries":{
"type":"integer",
"description":"Number of unresolved queries associated with this visit",
"format":"int32",
"example":0
}
},
"description":"List of visit statuses, including query counts, lock status, windowing, and other state."
},
"scheduledVisits":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"title":{
"type":"string",
"description":"Display title for the visit",
"example":"Baseline"
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Window start date for scheduling the visit",
"format":"date-time",
"example":"2025-10-10T14:30:31.892Z"
},
"scheduledDate":{
"type":"string",
"description":"Scheduled date for the visit",
"format":"date-time",
"example":"2025-10-12T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Window end date for scheduling the visit",
"format":"date-time",
"example":"2025-10-20T14:30:31.892Z"
},
"eventInstanceNum":{
"type":"number",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"cycleCount":{
"type":"number",
"description":"Cycle count for the visit",
"format":"int32",
"example":1
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
}
},
"description":"Scheduled visit details including scheduling windows and action to be taken"
},
"crntStateStudyVrsn":{
"type":"string",
"description":"Current subject state with study version string.",
"example":"5.0.1.2"
}
},
"description":"Response DTO detailing a subject's visit schedule, current study version state, visits (with status and windowing info), and scheduled visit actions."
},
"VisitsStatusRuleTargetsDto9":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"targets":{
"type":"array",
"description":"List of rule targets affected by this operation",
"example":[
"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC"
],
"items":{
"type":"string",
"description":"List of rule targets affected by this operation",
"example":"[\"DDEEFF00112233445566778899AABBCC.1DEEFF00112233445566778899AABBCC\"]"
}
},
"associatedStudyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitAction":{
"type":"string",
"description":"Action taken on the visit start date value. Acceptable values are SCREEN_ENABLE ,SCREEN_DISABLE ,RANDOMIZE_ENABLE ,RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE, COMPLETE_STUDY_DISABLE.",
"example":"SCREEN_ENABLE"
},
"visitStartDateLockedStatus":{
"type":"string",
"description":"Action performed on visit start date LOCKED, UNLOCKED, NEVER_LOCKED."
},
"visitStartDateLockedDateTime":{
"type":"string",
"description":"Timestamp when the visit start date was locked",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
}
},
"description":"Visit status update response including visit window warning, visit start date lock details, and rule targets"
},
"VisitsStatusDto50":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"visitWindowWarning":{
"type":"string",
"description":"Warning for the visit scheduling window",
"example":"NONE"
}
},
"description":"Visit status including event instance number (v4) and visit window warning"
},
"StudyDtoV6":{
"title":"StudyDto v6.0",
"type":"object",
"properties":{
"identity":{
"type":"string",
"description":"Study identity - concatenation of study id and version",
"example":"8C4ECDFD9C214D38B4E68D3107BA0AF9:1.0.0.3"
},
"id":{
"type":"string",
"description":"Study Unique GUID",
"format":"uuid"
},
"version":{
"type":"string",
"description":"Study version",
"example":"1.0.0.3"
},
"versionStart":{
"type":"string",
"description":"Version Start date",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"description":"Version End",
"format":"date-time",
"example":"3099-12-31T05:00:00Z"
},
"studyTitle":{
"type":"string",
"description":"Study Title or protocol number",
"example":"TICIPS001"
},
"studyDescription":{
"type":"string",
"description":"Study description or protocol title",
"example":"A randomized double blind placebo controlled study to investigate the safety of microphylla in healthy adult volunteers."
},
"contractCode":{
"type":"string",
"description":"Study contract code or identifier",
"example":"NCT00000419"
},
"versionTitle":{
"type":"string",
"description":"Study Title or protocol number",
"example":"TICIPS001:1.0.0.3"
},
"studyPhase":{
"type":"string",
"description":"Study phase",
"example":"II"
},
"therapeuticArea":{
"type":"string",
"description":"Study therapeutic area",
"example":"Infectious Diseases"
},
"openLabelBlinded":{
"type":"string",
"description":"Study type for open label and blinded",
"example":"DoubleBlinded"
},
"studyStatus":{
"type":"string",
"description":"Current study status",
"example":"APPROVED",
"enum":[
"DRAFT",
"TESTING",
"APPROVED",
"ARCHIVED"
]
},
"versionPreviousStatus":{
"type":"string",
"description":"Previous study status",
"example":"TESTING",
"enum":[
"DRAFT",
"TESTING",
"APPROVED",
"ARCHIVED"
]
},
"versionStatus":{
"type":"string",
"description":"Study version status",
"example":"Active, not recruiting"
},
"versionType":{
"type":"string",
"description":"Study version type",
"example":"Active, not recruiting"
},
"hasObjects":{
"type":"integer",
"description":"If study contains any artifacts",
"format":"int32",
"example":1
},
"draftVersionsCount":{
"type":"integer",
"description":"Count of study in draft mode",
"format":"int32",
"example":1
},
"testingVersionsCount":{
"type":"integer",
"description":"Count of study in testing mode",
"format":"int32",
"example":1
},
"approvedVersionsCount":{
"type":"integer",
"description":"Count of study in approved mode",
"format":"int32",
"example":1
},
"archivedVersionsCount":{
"type":"integer",
"description":"Count of study in archived mode",
"format":"int32",
"example":1
},
"everApprovedCount":{
"type":"integer",
"description":"If study was ever approved",
"format":"int32",
"example":1
},
"sourceStudyId":{
"type":"string",
"description":"Study Unique GUID",
"format":"uuid"
},
"sourceStudyVersion":{
"type":"string",
"description":"Source study version",
"format":"string",
"example":"1.0.0.1"
},
"sourceStudyTitle":{
"type":"string",
"description":"Source study title",
"format":"string",
"example":"The study"
},
"modes":{
"type":"array",
"items":{
"type":"string",
"description":"Study modes",
"example":"active",
"enum":[
"test",
"training",
"active"
]
}
},
"customerRefNo":{
"type":"string",
"description":"Customer reference number",
"example":"CRN-1001"
},
"description":{
"type":"string",
"description":"Study description",
"example":"A randomized double blind placebo controlled study."
},
"singleKitSettingId":{
"type":"string",
"description":"Single kit id",
"example":"KIT-001"
},
"sowNo":{
"type":"string",
"description":"SOW number",
"example":"SOW-2026-100"
},
"sponsorId":{
"type":"string",
"description":"Sponsor Id",
"example":"SPONSOR-001"
},
"studyStatusId":{
"type":"integer",
"description":"Study status Id",
"format":"int32",
"example":473
},
"useBlindingGroups":{
"type":"boolean",
"description":"Whether study uses blinding groups",
"example":false
},
"useLabelGroups":{
"type":"boolean",
"description":"Whether study uses label groups",
"example":false
},
"useShippinggroups":{
"type":"boolean",
"description":"Whether study uses shipping groups",
"example":false
},
"previousState":{
"type":"string",
"description":"Previous study state",
"example":"design",
"enum":[
"settings, active, design, test, training"
]
},
"studyState":{
"type":"string",
"description":"Current study state",
"example":"active",
"enum":[
"settings, active, design, test, training"
]
},
"lastModified":{
"type":"string",
"description":"Last modified timestamp",
"format":"date-time",
"example":"2026-02-21T06:30:00Z"
},
"systemCodeListId":{
"type":"string",
"description":"System Code List GUID",
"format":"uuid"
},
"companies":{
"type":"array",
"description":"Companies list who sponsor the study",
"example":"ABC Pharma",
"items":{
"type":"string",
"description":"Companies list who sponsor the study",
"example":"ABC Pharma"
}
},
"companyLabels":{
"type":"array",
"description":"Company labels associated with the study",
"example":"ABC Pharma",
"items":{
"type":"string",
"description":"Company labels associated with the study",
"example":"ABC Pharma"
}
},
"safetyCase":{
"type":"integer",
"description":"Safety case",
"format":"int32",
"example":1
},
"narrativeSettings":{
"type":"string",
"description":"Narrative settings",
"example":"Send Full Narrative (Editable)"
}
},
"description":"Information about a study for UI consumption."
},
"StudyDtoV5":{
"title":"StudyDto v5.0",
"type":"object",
"properties":{
"identity":{
"type":"string",
"description":"Study identity - concatenation of study id and version",
"example":"8C4ECDFD9C214D38B4E68D3107BA0AF9:1.0.0.3"
},
"id":{
"type":"string",
"description":"Study Unique GUID",
"format":"uuid"
},
"version":{
"type":"string",
"description":"Study version",
"example":"1.0.0.3"
},
"versionStart":{
"type":"string",
"description":"Version Start date",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"description":"Version End",
"format":"date-time",
"example":"3099-12-31T05:00:00Z"
},
"studyTitle":{
"type":"string",
"description":"Study Title or protocol number",
"example":"TICIPS001"
},
"studyDescription":{
"type":"string",
"description":"Study description or protocol title",
"example":"A randomized double blind placebo controlled study to investigate the safety of microphylla in healthy adult volunteers."
},
"contractCode":{
"type":"string",
"description":"Study contract code or identifier",
"example":"NCT00000419"
},
"versionTitle":{
"type":"string",
"description":"Study Title or protocol number",
"example":"TICIPS001:1.0.0.3"
},
"studyPhase":{
"type":"string",
"description":"Study phase",
"example":"II"
},
"therapeuticArea":{
"type":"string",
"description":"Study therapeutic area",
"example":"Infectious Diseases"
},
"openLabelBlinded":{
"type":"string",
"description":"Study type for open label and blinded",
"example":"DoubleBlinded"
},
"studyStatus":{
"type":"string",
"description":"Current study status",
"example":"APPROVED",
"enum":[
"DRAFT",
"TESTING",
"APPROVED",
"ARCHIVED"
]
},
"versionPreviousStatus":{
"type":"string",
"description":"Previous study status",
"example":"TESTING",
"enum":[
"DRAFT",
"TESTING",
"APPROVED",
"ARCHIVED"
]
},
"versionStatus":{
"type":"string",
"description":"Study version status",
"example":"Active, not recruiting"
},
"versionType":{
"type":"string",
"description":"Study version type",
"example":"Active, not recruiting"
},
"hasObjects":{
"type":"integer",
"description":"If study contains any artifacts",
"format":"int32",
"example":1
},
"draftVersionsCount":{
"type":"integer",
"description":"Count of study in draft mode",
"format":"int32",
"example":1
},
"testingVersionsCount":{
"type":"integer",
"description":"Count of study in testing mode",
"format":"int32",
"example":1
},
"approvedVersionsCount":{
"type":"integer",
"description":"Count of study in approved mode",
"format":"int32",
"example":1
},
"archivedVersionsCount":{
"type":"integer",
"description":"Count of study in archived mode",
"format":"int32",
"example":1
},
"everApprovedCount":{
"type":"integer",
"description":"If study was ever approved",
"format":"int32",
"example":1
},
"sourceStudyId":{
"type":"string",
"description":"Study Unique GUID",
"format":"uuid"
},
"sourceStudyVersion":{
"type":"string",
"description":"Source study version",
"format":"string",
"example":"1.0.0.1"
},
"sourceStudyTitle":{
"type":"string",
"description":"Source study title",
"format":"string",
"example":"The study"
},
"modes":{
"type":"array",
"items":{
"type":"string",
"description":"Study modes",
"example":"active",
"enum":[
"test",
"training",
"active"
]
}
},
"customerRefNo":{
"type":"string",
"description":"Customer reference number",
"example":"CRN-1001"
},
"description":{
"type":"string",
"description":"Study description",
"example":"A randomized double blind placebo controlled study."
},
"singleKitSettingId":{
"type":"string",
"description":"Single kit id",
"example":"KIT-001"
},
"sowNo":{
"type":"string",
"description":"SOW number",
"example":"SOW-2026-100"
},
"sponsorId":{
"type":"string",
"description":"Sponsor Id",
"example":"SPONSOR-001"
},
"studyStatusId":{
"type":"integer",
"description":"Study status Id",
"format":"int32",
"example":473
},
"useBlindingGroups":{
"type":"boolean",
"description":"Whether study uses blinding groups",
"example":false
},
"useLabelGroups":{
"type":"boolean",
"description":"Whether study uses label groups",
"example":false
},
"useShippinggroups":{
"type":"boolean",
"description":"Whether study uses shipping groups",
"example":false
},
"previousState":{
"type":"string",
"description":"Previous study state",
"example":"design",
"enum":[
"settings, active, design, test, training"
]
},
"studyState":{
"type":"string",
"description":"Current study state",
"example":"active",
"enum":[
"settings, active, design, test, training"
]
},
"lastModified":{
"type":"string",
"description":"Last modified timestamp",
"format":"date-time",
"example":"2026-02-21T06:30:00Z"
},
"systemCodeListId":{
"type":"string",
"description":"System Code List GUID",
"format":"uuid"
},
"companies":{
"type":"array",
"description":"Companies list who sponsor the study",
"example":"ABC Pharma",
"items":{
"type":"string",
"description":"Companies list who sponsor the study",
"example":"ABC Pharma"
}
},
"companyLabels":{
"type":"array",
"description":"Company labels associated with the study",
"example":"ABC Pharma",
"items":{
"type":"string",
"description":"Company labels associated with the study",
"example":"ABC Pharma"
}
}
},
"description":"Information about a study for UI consumption."
},
"StudyDtoV7":{
"title":"StudyDto v7.0",
"type":"object",
"properties":{
"identity":{
"type":"string",
"description":"Study identity - concatenation of study id and version",
"example":"8C4ECDFD9C214D38B4E68D3107BA0AF9:1.0.0.3"
},
"id":{
"type":"string",
"description":"Study Unique GUID",
"format":"uuid"
},
"version":{
"type":"string",
"description":"Study version",
"example":"1.0.0.3"
},
"versionStart":{
"type":"string",
"description":"Version Start date",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"description":"Version End",
"format":"date-time",
"example":"3099-12-31T05:00:00Z"
},
"studyTitle":{
"type":"string",
"description":"Study Title or protocol number",
"example":"TICIPS001"
},
"studyDescription":{
"type":"string",
"description":"Study description or protocol title",
"example":"A randomized double blind placebo controlled study to investigate the safety of microphylla in healthy adult volunteers."
},
"contractCode":{
"type":"string",
"description":"Study contract code or identifier",
"example":"NCT00000419"
},
"versionTitle":{
"type":"string",
"description":"Study Title or protocol number",
"example":"TICIPS001:1.0.0.3"
},
"studyPhase":{
"type":"string",
"description":"Study phase",
"example":"II"
},
"therapeuticArea":{
"type":"string",
"description":"Study therapeutic area",
"example":"Infectious Diseases"
},
"openLabelBlinded":{
"type":"string",
"description":"Study type for open label and blinded",
"example":"DoubleBlinded"
},
"studyStatus":{
"type":"string",
"description":"Current study status",
"example":"APPROVED",
"enum":[
"DRAFT",
"TESTING",
"APPROVED",
"ARCHIVED"
]
},
"versionPreviousStatus":{
"type":"string",
"description":"Previous study status",
"example":"TESTING",
"enum":[
"DRAFT",
"TESTING",
"APPROVED",
"ARCHIVED"
]
},
"versionStatus":{
"type":"string",
"description":"Study version status",
"example":"Active, not recruiting"
},
"versionType":{
"type":"string",
"description":"Study version type",
"example":"Active, not recruiting"
},
"hasObjects":{
"type":"integer",
"description":"If study contains any artifacts",
"format":"int32",
"example":1
},
"draftVersionsCount":{
"type":"integer",
"description":"Count of study in draft mode",
"format":"int32",
"example":1
},
"testingVersionsCount":{
"type":"integer",
"description":"Count of study in testing mode",
"format":"int32",
"example":1
},
"approvedVersionsCount":{
"type":"integer",
"description":"Count of study in approved mode",
"format":"int32",
"example":1
},
"archivedVersionsCount":{
"type":"integer",
"description":"Count of study in archived mode",
"format":"int32",
"example":1
},
"everApprovedCount":{
"type":"integer",
"description":"If study was ever approved",
"format":"int32",
"example":1
},
"sourceStudyId":{
"type":"string",
"description":"Study Unique GUID",
"format":"uuid"
},
"sourceStudyVersion":{
"type":"string",
"description":"Source study version",
"format":"string",
"example":"1.0.0.1"
},
"sourceStudyTitle":{
"type":"string",
"description":"Source study title",
"format":"string",
"example":"The study"
},
"modes":{
"type":"array",
"items":{
"type":"string",
"description":"Study modes",
"example":"active",
"enum":[
"test",
"training",
"active"
]
}
},
"customerRefNo":{
"type":"string",
"description":"Customer reference number",
"example":"CRN-1001"
},
"description":{
"type":"string",
"description":"Study description",
"example":"A randomized double blind placebo controlled study."
},
"singleKitSettingId":{
"type":"string",
"description":"Single kit id",
"example":"KIT-001"
},
"sowNo":{
"type":"string",
"description":"SOW number",
"example":"SOW-2026-100"
},
"sponsorId":{
"type":"string",
"description":"Sponsor Id",
"example":"SPONSOR-001"
},
"studyStatusId":{
"type":"integer",
"description":"Study status Id",
"format":"int32",
"example":473
},
"useBlindingGroups":{
"type":"boolean",
"description":"Whether study uses blinding groups",
"example":false
},
"useLabelGroups":{
"type":"boolean",
"description":"Whether study uses label groups",
"example":false
},
"useShippinggroups":{
"type":"boolean",
"description":"Whether study uses shipping groups",
"example":false
},
"previousState":{
"type":"string",
"description":"Previous study state",
"example":"design",
"enum":[
"settings, active, design, test, training"
]
},
"studyState":{
"type":"string",
"description":"Current study state",
"example":"active",
"enum":[
"settings, active, design, test, training"
]
},
"lastModified":{
"type":"string",
"description":"Last modified timestamp",
"format":"date-time",
"example":"2026-02-21T06:30:00Z"
},
"systemCodeListId":{
"type":"string",
"description":"System Code List GUID",
"format":"uuid"
},
"companies":{
"type":"array",
"description":"Companies list who sponsor the study",
"example":"ABC Pharma",
"items":{
"type":"string",
"description":"Companies list who sponsor the study",
"example":"ABC Pharma"
}
},
"companyLabels":{
"type":"array",
"description":"Company labels associated with the study",
"example":"ABC Pharma",
"items":{
"type":"string",
"description":"Company labels associated with the study",
"example":"ABC Pharma"
}
},
"safetyCase":{
"type":"integer",
"description":"Safety case",
"format":"int32",
"example":1
},
"narrativeSettings":{
"type":"string",
"description":"Narrative settings",
"example":"Send Full Narrative (Editable)"
},
"safetyIntegration":{
"type":"boolean",
"description":"Safety Integration",
"example":true
}
},
"description":"Information about a study for UI consumption."
},
"CountryDto":{
"title":"CountryDto v1.0",
"required":[
"id",
"isoCode",
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country ID",
"type":"string",
"description":"Unique country identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this country version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-2 ISO code identifying the country.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official country name.",
"example":"United States"
}
},
"description":"Country details returned by the SDF APIs.",
"example":[
{
"id":"A0E1B2C3D4E5F67890123456789ABCDE",
"versionStart":"2025-03-16T12:00:00.000Z",
"isoCode":"US",
"name":"United States"
}
]
},
"SDFCountriesResponse":{
"type":"object",
"properties":{
"sdfCountriesList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFCountryDto"
}
}
}
},
"SDFCountryDto":{
"required":[
"countryId",
"primarySupply",
"sdfId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"countryId":{
"type":"string",
"format":"uuid"
},
"stateId":{
"type":"string",
"format":"uuid"
},
"sdfId":{
"type":"string",
"format":"uuid"
},
"primarySupply":{
"maxLength":10,
"minLength":0,
"type":"string",
"example":"sample"
},
"associationOperationType":{
"type":"string",
"writeOnly":true
}
},
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"SDFResponse":{
"title":"SDFResponse",
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Status of the response, either 'success' or an error indication.",
"example":"success"
},
"result":{
"type":"object",
"description":"The result object for successful requests. Type depends on the API operation.",
"example":{
"hasMore":"true",
"totalResults":5,
"count":5,
"data":[
]
}
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
},
"description":"Wrapper for service responses containing result or error data."
},
"SDFCountriesRequest":{
"type":"object",
"properties":{
"sdfCountriesList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFCountryDto"
}
}
}
},
"Countries":{
"title":"Country",
"required":[
"id",
"isoCode",
"isoCode3",
"name",
"versionStart"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the latest change made to this record.",
"example":"Protocol update requested by study operations."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional user comment about the latest change.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country Id",
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"description":"Unique country identifier.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Version start timestamp.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"ISO alpha-2 country code.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Country display name.",
"example":"United States"
},
"isoCode3":{
"title":"ISO Code3",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"ISO alpha-3 country code.",
"example":"USA"
}
},
"description":"Country entity metadata."
},
"StateDto":{
"title":"StateDto v1.0",
"type":"object",
"properties":{
"id":{
"title":"State ID",
"type":"string",
"description":"Unique state identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this state version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"code":{
"title":"State Code",
"type":"string",
"description":"ISO code identifying the state.",
"example":"CA"
},
"name":{
"title":"State Name",
"type":"string",
"description":"Official state name.",
"example":"California"
},
"reason":{
"title":"Reason",
"type":"string",
"description":"Reason metadata for the state.",
"example":"Legacy mapping"
},
"comment":{
"title":"Comment",
"type":"string",
"description":"Additional comment for the state.",
"example":"Population threshold 1000000"
}
},
"description":"State metadata returned by the Countries APIs.",
"example":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000"
}
]
},
"StatesResponse":{
"title":"StatesResponse v1.0",
"type":"object",
"properties":{
"states":{
"title":"StateDto v1.0",
"type":"object",
"properties":{
"id":{
"title":"State ID",
"type":"string",
"description":"Unique state identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this state version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"code":{
"title":"State Code",
"type":"string",
"description":"ISO code identifying the state.",
"example":"CA"
},
"name":{
"title":"State Name",
"type":"string",
"description":"Official state name.",
"example":"California"
},
"reason":{
"title":"Reason",
"type":"string",
"description":"Reason metadata for the state.",
"example":"Legacy mapping"
},
"comment":{
"title":"Comment",
"type":"string",
"description":"Additional comment for the state.",
"example":"Population threshold 1000000"
}
},
"description":"State metadata returned by the Countries APIs.",
"example":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000"
}
]
}
},
"description":"Response wrapping the state list."
},
"SDFCountriesAndStatesResponse":{
"title":"SDFCountriesAndStatesResponse v1.0",
"type":"object",
"properties":{
"sdfCountriesAndStatesList":{
"title":"SDFCountryAndStateDto v1.0",
"required":[
"countryId",
"primarySupply",
"sdfId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Country ID",
"type":"string",
"description":"Unique identifier for the SDF-country association (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this association version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Unique identifier of the country linked to the SDF (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Unique SDF identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"primarySupply":{
"title":"Primary Supply",
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Primary supply type for the SDF-country association.",
"example":"PRIMARY"
},
"stateId":{
"title":"State ID",
"type":"string",
"description":"Optional state identifier linked to the SDF association.",
"format":"uuid"
}
},
"description":"SDF-country association extended with an optional state.",
"example":[
{
"id":"3F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"stateId":"9F2504E04F8911D39A0C0305E82C3301",
"sdfId":"9C10C9F402C44BD6A7CFC7F4F1A6EED8",
"primarySupply":"PRIMARY"
}
]
},
"countries":{
"title":"CountryDto v1.0",
"required":[
"id",
"isoCode",
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country ID",
"type":"string",
"description":"Unique country identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this country version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-2 ISO code identifying the country.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official country name.",
"example":"United States"
}
},
"description":"Country details returned by the SDF APIs.",
"example":[
{
"id":"A0E1B2C3D4E5F67890123456789ABCDE",
"versionStart":"2025-03-16T12:00:00.000Z",
"isoCode":"US",
"name":"United States"
}
]
}
},
"description":"Response containing SDF country/state associations."
},
"SDFCountryAndStateDto":{
"title":"SDFCountryAndStateDto v1.0",
"required":[
"countryId",
"primarySupply",
"sdfId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Country ID",
"type":"string",
"description":"Unique identifier for the SDF-country association (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this association version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Unique identifier of the country linked to the SDF (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Unique SDF identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"primarySupply":{
"title":"Primary Supply",
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Primary supply type for the SDF-country association.",
"example":"PRIMARY"
},
"stateId":{
"title":"State ID",
"type":"string",
"description":"Optional state identifier linked to the SDF association.",
"format":"uuid"
}
},
"description":"SDF-country association extended with an optional state.",
"example":[
{
"countryId":"B1B8327AFAA6412287106192AB5984EF",
"stateId":"B1B8327AFAA6412287106192AB5984EF",
"sdfId":"B1B8327AFAA6412287106192AB5984EF"
}
]
},
"SDFCountriesAndStatesRequest":{
"title":"SDFCountriesAndStatesRequest v1.0",
"type":"object",
"properties":{
"sdfCountriesAndStatesList":{
"type":"array",
"example":[
{
"countryId":"B1B8327AFAA6412287106192AB5984EF",
"stateId":"B1B8327AFAA6412287106192AB5984EF",
"sdfId":"B1B8327AFAA6412287106192AB5984EF"
}
],
"items":{
"$ref":"#/components/schemas/SDFCountryAndStateDto"
}
},
"sdfCountriesAnStatesList":{
"type":"array",
"example":[
{
"countryId":"B1B8327AFAA6412287106192AB5984EF",
"stateId":"B1B8327AFAA6412287106192AB5984EF",
"sdfId":"B1B8327AFAA6412287106192AB5984EF"
}
],
"items":{
"$ref":"#/components/schemas/SDFCountryAndStateDto"
}
}
},
"description":"Payload containing SDF associations that include states."
},
"CountriesResponse2":{
"title":"CountriesResponse v2.0",
"type":"object",
"properties":{
"countries":{
"title":"CountryDto2 v2.0",
"required":[
"id",
"isoCode",
"isoCode3",
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country ID",
"type":"string",
"description":"Unique country identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this country version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-2 ISO code identifying the country.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official country name.",
"example":"United States"
},
"isoCode3":{
"title":"ISO Code 3",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-3 ISO code identifying the country.",
"example":"USA"
}
},
"description":"Country metadata for ISO3-enabled APIs.",
"example":[
{
"id":"3F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"isoCode":"US",
"name":"United States",
"isoCode3":"USA"
}
]
}
},
"description":"Response wrapping the ISO3-based country list."
},
"CountryDto2":{
"title":"CountryDto2 v2.0",
"required":[
"id",
"isoCode",
"isoCode3",
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country ID",
"type":"string",
"description":"Unique country identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this country version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-2 ISO code identifying the country.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official country name.",
"example":"United States"
},
"isoCode3":{
"title":"ISO Code 3",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-3 ISO code identifying the country.",
"example":"USA"
}
},
"description":"Country metadata for ISO3-enabled APIs.",
"example":[
{
"id":"A0E1B2C3D4E5F67890123456789ABCDE",
"versionStart":"2025-03-16T12:00:00.000Z",
"isoCode":"US",
"name":"United States",
"isoCode3":"USA"
}
]
},
"StateDto2":{
"title":"StateDto2 v2.0",
"type":"object",
"properties":{
"id":{
"title":"State ID",
"type":"string",
"description":"Unique state identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this state version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"code":{
"title":"State Code",
"type":"string",
"description":"ISO code identifying the state.",
"example":"CA"
},
"name":{
"title":"State Name",
"type":"string",
"description":"Official state name.",
"example":"California"
},
"reason":{
"title":"Reason",
"type":"string",
"description":"Reason metadata for the state.",
"example":"Legacy mapping"
},
"comment":{
"title":"Comment",
"type":"string",
"description":"Additional comment for the state.",
"example":"Population threshold 1000000"
},
"hidden":{
"title":"Hidden",
"type":"boolean",
"description":"Indicates whether the state is hidden from derived lists.",
"example":true
}
},
"description":"State metadata that includes the hidden flag.",
"example":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000",
"hidden":false
}
]
},
"StatesResponse2":{
"title":"StatesResponse v1.0",
"type":"object",
"properties":{
"states":{
"title":"StateDto2 v2.0",
"type":"object",
"properties":{
"id":{
"title":"State ID",
"type":"string",
"description":"Unique state identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this state version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"code":{
"title":"State Code",
"type":"string",
"description":"ISO code identifying the state.",
"example":"CA"
},
"name":{
"title":"State Name",
"type":"string",
"description":"Official state name.",
"example":"California"
},
"reason":{
"title":"Reason",
"type":"string",
"description":"Reason metadata for the state.",
"example":"Legacy mapping"
},
"comment":{
"title":"Comment",
"type":"string",
"description":"Additional comment for the state.",
"example":"Population threshold 1000000"
},
"hidden":{
"title":"Hidden",
"type":"boolean",
"description":"Indicates whether the state is hidden from derived lists.",
"example":true
}
},
"description":"State metadata that includes the hidden flag.",
"example":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000",
"hidden":false
}
]
}
},
"description":"Response wrapping the state list."
},
"SDFCountriesResponse2":{
"title":"SDFCountriesResponse v2.0",
"type":"object",
"properties":{
"sdfCountriesList":{
"title":"SDFCountryDto v1.0",
"required":[
"countryId",
"primarySupply",
"sdfId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Country ID",
"type":"string",
"description":"Unique identifier for the SDF-country association (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this association version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Unique identifier of the country linked to the SDF (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Unique SDF identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"primarySupply":{
"title":"Primary Supply",
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Primary supply type for the SDF-country association.",
"example":"PRIMARY"
}
},
"description":"SDF-country association details returned by the APIs.",
"example":[
{
"id":"3F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"sdfId":"9C10C9F402C44BD6A7CFC7F4F1A6EED8",
"primarySupply":"PRIMARY"
}
]
},
"countries":{
"title":"CountryDto2 v2.0",
"required":[
"id",
"isoCode",
"isoCode3",
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country ID",
"type":"string",
"description":"Unique country identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this country version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-2 ISO code identifying the country.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official country name.",
"example":"United States"
},
"isoCode3":{
"title":"ISO Code 3",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-3 ISO code identifying the country.",
"example":"USA"
}
},
"description":"Country metadata for ISO3-enabled APIs.",
"example":[
{
"id":"A0E1B2C3D4E5F67890123456789ABCDE",
"versionStart":"2025-03-16T12:00:00.000Z",
"isoCode":"US",
"name":"United States",
"isoCode3":"USA"
}
]
}
},
"description":"Response containing ISO3-based country/SDF associations."
},
"CountriesResponse4":{
"title":"CountriesResponse v4.0",
"type":"object",
"properties":{
"countriesStates":{
"title":"CountryStatesDto v4.0",
"required":[
"id",
"isoCode",
"isoCode3",
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country ID",
"type":"string",
"description":"Unique country identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this country version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-2 ISO code identifying the country.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official country name.",
"example":"United States"
},
"isoCode3":{
"title":"ISO Code 3",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-3 ISO code identifying the country.",
"example":"USA"
},
"hidden":{
"title":"Hidden",
"type":"boolean",
"description":"Indicates whether the country is hidden from derived lists.",
"example":true
},
"states":{
"title":"StateDto2 v2.0",
"type":"object",
"properties":{
"id":{
"title":"State ID",
"type":"string",
"description":"Unique state identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this state version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"code":{
"title":"State Code",
"type":"string",
"description":"ISO code identifying the state.",
"example":"CA"
},
"name":{
"title":"State Name",
"type":"string",
"description":"Official state name.",
"example":"California"
},
"reason":{
"title":"Reason",
"type":"string",
"description":"Reason metadata for the state.",
"example":"Legacy mapping"
},
"comment":{
"title":"Comment",
"type":"string",
"description":"Additional comment for the state.",
"example":"Population threshold 1000000"
},
"hidden":{
"title":"Hidden",
"type":"boolean",
"description":"Indicates whether the state is hidden from derived lists.",
"example":true
}
},
"description":"State metadata that includes the hidden flag.",
"example":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000",
"hidden":false
}
]
}
},
"description":"Country metadata plus hidden state metadata for v4 APIs.",
"example":[
{
"id":"3F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"isoCode":"US",
"name":"United States",
"isoCode3":"USA",
"hidden":false,
"states":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000",
"hidden":false
}
]
}
]
}
},
"description":"Response wrapping the v4 country list with hidden state metadata."
},
"CountryStatesDto2":{
"title":"CountryStatesDto v4.0",
"required":[
"id",
"isoCode",
"isoCode3",
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Country ID",
"type":"string",
"description":"Unique country identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this country version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"isoCode":{
"title":"ISO Code",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-2 ISO code identifying the country.",
"example":"US"
},
"name":{
"title":"Country Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official country name.",
"example":"United States"
},
"isoCode3":{
"title":"ISO Code 3",
"maxLength":10,
"minLength":1,
"type":"string",
"description":"Alpha-3 ISO code identifying the country.",
"example":"USA"
},
"hidden":{
"title":"Hidden",
"type":"boolean",
"description":"Indicates whether the country is hidden from derived lists.",
"example":true
},
"states":{
"title":"StateDto2 v2.0",
"type":"object",
"properties":{
"id":{
"title":"State ID",
"type":"string",
"description":"Unique state identifier (UUID, 32-character uppercase hexadecimal string).",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this state version was created.",
"format":"date-time",
"example":"2025-03-16T12:00:00Z"
},
"code":{
"title":"State Code",
"type":"string",
"description":"ISO code identifying the state.",
"example":"CA"
},
"name":{
"title":"State Name",
"type":"string",
"description":"Official state name.",
"example":"California"
},
"reason":{
"title":"Reason",
"type":"string",
"description":"Reason metadata for the state.",
"example":"Legacy mapping"
},
"comment":{
"title":"Comment",
"type":"string",
"description":"Additional comment for the state.",
"example":"Population threshold 1000000"
},
"hidden":{
"title":"Hidden",
"type":"boolean",
"description":"Indicates whether the state is hidden from derived lists.",
"example":true
}
},
"description":"State metadata that includes the hidden flag.",
"example":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000",
"hidden":false
}
]
}
},
"description":"Country metadata plus hidden state metadata for v4 APIs.",
"example":[
{
"id":"3F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"isoCode":"US",
"name":"United States",
"isoCode3":"USA",
"hidden":false,
"states":[
{
"id":"9F2504E04F8911D39A0C0305E82C3301",
"versionStart":"2025-03-16T12:00:00.000Z",
"code":"CA",
"name":"California",
"reason":"Legacy mapping",
"comment":"Population threshold 1000000",
"hidden":false
}
]
}
]
},
"SDFsPaginatedResponseV2":{
"title":"SDFsPaginatedResponse v2.0",
"type":"object",
"properties":{
"hasMore":{
"title":"SDFsPaginatedResponse v2.0",
"type":"boolean",
"description":"Flag indicating whether more pages of data are available.",
"example":true
},
"totalResults":{
"title":"SDFsPaginatedResponse v2.0",
"type":"integer",
"description":"Total number of rows matching the paginated request.",
"format":"int32",
"example":250
},
"count":{
"title":"SDFsPaginatedResponse v2.0",
"type":"integer",
"description":"Number of rows returned in this page.",
"format":"int32",
"example":25
},
"limit":{
"title":"SDFsPaginatedResponse v2.0",
"type":"integer",
"description":"Maximum number of entries requested per page.",
"format":"int32",
"example":100
},
"offset":{
"title":"SDFsPaginatedResponse v2.0",
"type":"integer",
"description":"Pagination offset used to compute the returned subset.",
"format":"int32",
"example":0
},
"resultData":{
"title":"SDFsPaginatedResponse v2.0",
"type":"object",
"description":"Payload of the paginated response.",
"example":{
}
}
},
"description":"Paginated response wrapper used by CTMS/SDF endpoints."
},
"Contacts":{
"required":[
"contactType",
"firstName",
"lastName",
"status",
"studyAgnostic",
"studyId"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the latest change made to this record.",
"example":"Protocol update requested by study operations."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional user comment about the latest change.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"description":"Unique identifier for this record.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"Timestamp when this version became active.",
"format":"date-time",
"example":"2026-03-16T12:00:00Z"
},
"firstName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Represents first name for this record.",
"example":"Sample Name"
},
"lastName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Represents last name for this record.",
"example":"Sample Name"
},
"middleName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Represents middle name for this record.",
"example":"Sample Name"
},
"suffix":{
"type":"string",
"description":"Represents suffix for this record.",
"format":"uuid"
},
"prefix":{
"type":"string",
"description":"Represents prefix for this record.",
"format":"uuid"
},
"status":{
"type":"string",
"description":"Represents status for this record.",
"format":"uuid"
},
"degree":{
"maxLength":200,
"minLength":0,
"type":"string",
"description":"Represents degree for this record.",
"example":"Sample Value"
},
"contactId":{
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Represents contact id for this record.",
"example":"SITE-001"
},
"timezone":{
"type":"string",
"description":"Represents timezone for this record.",
"example":"UTC"
},
"taxId":{
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Represents tax id for this record.",
"example":"Sample Value"
},
"primarySpecialityId":{
"type":"string",
"description":"Represents primary speciality id for this record.",
"format":"uuid"
},
"disbarmentStart":{
"type":"string",
"description":"Represents disbarment start for this record.",
"format":"date-time",
"example":"2026-03-16T12:00:00Z"
},
"disbarmentEnd":{
"type":"string",
"description":"Represents disbarment end for this record.",
"format":"date-time",
"example":"2026-03-16T12:00:00Z"
},
"contactType":{
"type":"string",
"description":"Represents contact type for this record.",
"format":"uuid"
},
"studyId":{
"type":"string",
"description":"Identifier of the related study.",
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
"studyAgnostic":{
"type":"string",
"description":"Represents study agnostic for this record.",
"example":"N"
},
"suffixCodeValue":{
"type":"string",
"description":"Represents suffix code value for this record.",
"example":"Sample Value"
},
"prefixCodeValue":{
"type":"string",
"description":"Represents prefix code value for this record.",
"example":"Sample Value"
},
"statusCodeValue":{
"type":"string",
"description":"Display value for the status code.",
"example":"ACTIVE"
}
}
},
"ContactDto":{
"title":"ContactDto",
"required":[
"firstName",
"lastName"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"firstName":{
"title":"First Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Contact first name.",
"example":"John"
},
"lastName":{
"title":"Last Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Contact last name.",
"example":"Doe"
},
"middleName":{
"title":"Middle Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Contact middle name.",
"example":"Michael"
},
"suffix":{
"type":"string",
"format":"uuid"
},
"suffixCodeValue":{
"title":"Suffix Code",
"maxLength":200,
"minLength":0,
"type":"string",
"description":"Display value for the suffix code.",
"example":"Jr."
},
"prefix":{
"type":"string",
"format":"uuid"
},
"prefixCodeValue":{
"title":"Prefix Code",
"maxLength":200,
"minLength":0,
"type":"string",
"description":"Display value for the prefix code.",
"example":"Dr."
},
"status":{
"type":"string",
"format":"uuid"
},
"statusCodeValue":{
"title":"Status Code",
"maxLength":200,
"minLength":0,
"type":"string",
"description":"Display value for the status.",
"example":"Active"
},
"degree":{
"title":"Degree",
"maxLength":200,
"minLength":0,
"type":"string",
"description":"Academic degree associated with the contact.",
"example":"MD"
},
"contactId":{
"title":"Contact Identifier",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Business identifier assigned to the contact.",
"example":"CONTACT-123"
},
"timezone":{
"title":"Timezone",
"type":"string",
"description":"Default timezone for the contact.",
"example":"UTC"
},
"taxId":{
"title":"Tax ID",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Tax identifier associated with the contact.",
"example":"TAX-123"
},
"primarySpecialityId":{
"type":"string",
"format":"uuid"
},
"disbarmentStart":{
"title":"Disbarment Start",
"type":"string",
"description":"Timestamp when the contact was disbarred.",
"format":"date-time",
"example":"2024-01-15T00:00:00Z"
},
"disbarmentEnd":{
"title":"Disbarment End",
"type":"string",
"description":"Timestamp when the disbarment period ends.",
"format":"date-time",
"example":"2024-12-31T00:00:00Z"
},
"contactType":{
"type":"string",
"format":"uuid"
}
},
"description":"Represents the contact entity details.",
"example":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"firstName":"John",
"lastName":"Doe"
}
},
"ContactModelDto":{
"title":"ContactModelDto",
"required":[
"contact",
"contactAddressesDetails"
],
"type":"object",
"properties":{
"contact":{
"$ref":"#/components/schemas/ContactDto"
},
"properties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"contactAddressesDetails":{
"title":"EntityAddressAssociationDto",
"required":[
"addressPostalcode"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Address Association ID",
"type":"string",
"description":"Unique identifier for the entity address association.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"entityId":{
"title":"Entity ID",
"type":"string",
"description":"Identifier of the entity owning the address.",
"format":"uuid"
},
"mainPrimary":{
"title":"Main Primary Flag",
"type":"boolean",
"description":"Indicates if this is the main primary address.",
"example":true
},
"entityType":{
"title":"Entity Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of entity for the address.",
"example":"Contact"
},
"addressType":{
"title":"Address Type",
"type":"string",
"description":"Identifier for the address type.",
"format":"uuid"
},
"addressTypeCodeValue":{
"title":"Address Type Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the address type.",
"example":"Primary"
},
"country":{
"title":"Country ID",
"type":"string",
"description":"Identifier for the country.",
"format":"uuid"
},
"countryCodeValue":{
"title":"Country Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the country code.",
"example":"USA"
},
"addressPostalcode":{
"title":"Postal Code",
"maxLength":20,
"minLength":0,
"type":"string",
"description":"Postal code for the address.",
"example":"80202"
},
"addressProperties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
},
"addressStreet1":{
"type":"string"
},
"addressStreet2":{
"type":"string"
},
"addressCity":{
"type":"string"
},
"addressStateOrProvOrCounty":{
"type":"string",
"format":"uuid"
},
"addressStateOrProvOrCountyCodeValue":{
"type":"string"
}
},
"description":"Represents an address linked to an entity.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"modes":{
"title":"ModeDto",
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Mode ID",
"type":"string",
"description":"Unique identifier for the mode assignment.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"entityId":{
"title":"Entity ID",
"type":"string",
"description":"Identifier of the associated entity.",
"format":"uuid"
},
"entityType":{
"title":"Entity Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of entity tied to the mode.",
"example":"Contact"
},
"mode":{
"title":"Mode",
"type":"string",
"description":"Identifier of the mode.",
"format":"uuid"
},
"modeCodeValue":{
"title":"Mode Code Value",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Display value for the mode.",
"example":"Operational"
}
},
"description":"Represents a mode assignment for an entity.",
"example":[
"test"
]
}
},
"description":"Payload describing a contact with addresses, properties, and modes."
},
"EntityAddressAssociationDto":{
"title":"EntityAddressAssociationDto",
"required":[
"addressPostalcode"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Address Association ID",
"type":"string",
"description":"Unique identifier for the entity address association.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"entityId":{
"title":"Entity ID",
"type":"string",
"description":"Identifier of the entity owning the address.",
"format":"uuid"
},
"mainPrimary":{
"title":"Main Primary Flag",
"type":"boolean",
"description":"Indicates if this is the main primary address.",
"example":true
},
"entityType":{
"title":"Entity Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of entity for the address.",
"example":"Contact"
},
"addressType":{
"title":"Address Type",
"type":"string",
"description":"Identifier for the address type.",
"format":"uuid"
},
"addressTypeCodeValue":{
"title":"Address Type Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the address type.",
"example":"Primary"
},
"country":{
"title":"Country ID",
"type":"string",
"description":"Identifier for the country.",
"format":"uuid"
},
"countryCodeValue":{
"title":"Country Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the country code.",
"example":"USA"
},
"addressPostalcode":{
"title":"Postal Code",
"maxLength":20,
"minLength":0,
"type":"string",
"description":"Postal code for the address.",
"example":"80202"
},
"addressProperties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
},
"addressStreet1":{
"type":"string"
},
"addressStreet2":{
"type":"string"
},
"addressCity":{
"type":"string"
},
"addressStateOrProvOrCounty":{
"type":"string",
"format":"uuid"
},
"addressStateOrProvOrCountyCodeValue":{
"type":"string"
}
},
"description":"Represents an address linked to an entity.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"ModeDto":{
"title":"ModeDto",
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Mode ID",
"type":"string",
"description":"Unique identifier for the mode assignment.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"entityId":{
"title":"Entity ID",
"type":"string",
"description":"Identifier of the associated entity.",
"format":"uuid"
},
"entityType":{
"title":"Entity Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of entity tied to the mode.",
"example":"Contact"
},
"mode":{
"title":"Mode",
"type":"string",
"description":"Identifier of the mode.",
"format":"uuid"
},
"modeCodeValue":{
"title":"Mode Code Value",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Display value for the mode.",
"example":"Operational"
}
},
"description":"Represents a mode assignment for an entity.",
"example":[
"test"
]
},
"PropertyDto":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"ContactOrganizationDeleteReasonDto":{
"title":"ContactOrganizationDeleteReasonDto",
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"reasonForDelete":{
"title":"ReasonForDelete",
"type":"string",
"description":"Reason explaining why the delete operation is requested.",
"example":"No longer active"
}
},
"description":"Request carrying the reason to delete an entity."
},
"ContactFieldsDto":{
"title":"ContactFieldsDto",
"type":"object",
"properties":{
"contactFields":{
"title":"Field",
"type":"object",
"properties":{
"fieldName":{
"title":"Field Name",
"type":"string",
"description":"Field name. The acceptable values are: TENANTID, STUDYID, COUNTRY, SITEID, INVID, INVNAM, USUBJID, SCRNID, SUBJID, VISITNUM, VISIT, UNSCHED, SVSTDTC, DOMAIN, LAB ID, LAB NAME, REPEATNUMBER, SREPEATID, SREPEATNUMBER, ENTERED BY, ENTERED DATE, LAST CHANGED BY, LAST CHANGED DATE etc.",
"example":"TENANTID"
},
"fieldValue":{
"title":"Field Value",
"type":"string",
"description":"Value reported for the field.",
"example":"TENANT123"
},
"valueExists":{
"title":"Value Exists",
"type":"boolean",
"description":"Indicates whether the value already exists.",
"example":true
}
},
"description":"Contains field details.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
},
"description":"Payload containing the contact fields to validate."
},
"FacilityDto":{
"title":"FACILITY_DTO_TITLE",
"required":[
"entityId",
"entityType",
"facilityName"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"entityId":{
"type":"string",
"format":"uuid"
},
"entityType":{
"title":"FACILITY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"FACILITY_DTO_ENTITY_TYPE_DESC",
"example":"FACILITY"
},
"facilityName":{
"title":"FACILITY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"FACILITY_DTO_NAME_DESC",
"example":"Acme Research Facility"
}
},
"description":"FACILITY_DTO_DESC"
},
"FacilityModelResponse":{
"title":"FACILITY_MODEL_RESPONSE_TITLE",
"type":"object",
"properties":{
"facilityDto":{
"$ref":"#/components/schemas/FacilityDto"
},
"properties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
}
},
"description":"FACILITY_MODEL_RESPONSE_DESC",
"example":[
"test"
]
},
"FacilityModelResponseList":{
"title":"FACILITY_MODEL_RESPONSE_LIST_TITLE",
"type":"object",
"properties":{
"facilityModels":{
"title":"FACILITY_MODEL_RESPONSE_TITLE",
"type":"object",
"properties":{
"facilityDto":{
"$ref":"#/components/schemas/FacilityDto"
},
"properties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
}
},
"description":"FACILITY_MODEL_RESPONSE_DESC",
"example":[
"test"
]
}
},
"description":"FACILITY_MODEL_RESPONSE_LIST_DESC"
},
"FacilityModelRequest":{
"title":"FACILITY_MODEL_REQUEST_TITLE",
"type":"object",
"properties":{
"facilityDto":{
"$ref":"#/components/schemas/FacilityDto"
},
"properties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
},
"entityOperationType":{
"title":"FACILITY_MODEL_REQUEST_OPERATION_TITLE",
"type":"string",
"description":"FACILITY_MODEL_REQUEST_OPERATION_DESC",
"example":"CREATE"
}
},
"description":"FACILITY_MODEL_REQUEST_DESC",
"example":[
"test"
]
},
"FacilityModelRequestList":{
"title":"FACILITY_MODEL_REQUEST_LIST_TITLE",
"type":"object",
"properties":{
"facilityModels":{
"title":"FACILITY_MODEL_REQUEST_TITLE",
"type":"object",
"properties":{
"facilityDto":{
"$ref":"#/components/schemas/FacilityDto"
},
"properties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
},
"entityOperationType":{
"title":"FACILITY_MODEL_REQUEST_OPERATION_TITLE",
"type":"string",
"description":"FACILITY_MODEL_REQUEST_OPERATION_DESC",
"example":"CREATE"
}
},
"description":"FACILITY_MODEL_REQUEST_DESC",
"example":[
"test"
]
}
},
"description":"FACILITY_MODEL_REQUEST_LIST_DESC"
},
"EntityManagementActionRequest":{
"title":"ENTITY_MANAGEMENT_ACTION_REQUEST_TITLE",
"required":[
"entityManagementActionRequest"
],
"type":"object",
"properties":{
"entityManagementActionRequest":{
"$ref":"#/components/schemas/EntityManagementActionRequestDto"
}
},
"description":"ENTITY_MANAGEMENT_ACTION_REQUEST_DESC"
},
"EntityManagementActionRequestDto":{
"title":"ENTITY_MANAGEMENT_ACTION_REQUEST_DTO_TITLE",
"required":[
"entityAction"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityAction":{
"title":"ENTITY_MANAGEMENT_ACTION_REQUEST_DTO_ACTION_TITLE",
"maxLength":25,
"minLength":0,
"type":"string",
"description":"ENTITY_MANAGEMENT_ACTION_REQUEST_DTO_ACTION_DESC",
"example":"TRANSFER"
},
"targetTenantEntityId":{
"type":"string",
"format":"uuid"
}
},
"description":"ENTITY_MANAGEMENT_ACTION_REQUEST_DTO_DESC",
"example":{
"targetTenantEntityId":"B1B8327AFAA6412287106192AB5984EF"
}
},
"EntityManagementRequest":{
"title":"ENTITY_MANAGEMENT_REQUEST_TITLE",
"required":[
"entityManagementRequest"
],
"type":"object",
"properties":{
"entityManagementRequest":{
"title":"MANAGE_STUDY_ENTITY_DTO_TITLE",
"required":[
"studyId"
],
"type":"object",
"properties":{
"studyId":{
"title":"MANAGE_STUDY_ENTITY_DTO_STUDY_ID_TITLE",
"type":"string",
"description":"MANAGE_STUDY_ENTITY_DTO_STUDY_ID_DESC",
"format":"uuid"
},
"studyEntities":{
"title":"MANAGE_ENTITY_DTO_TITLE",
"required":[
"entityAction",
"entityType"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"title":"MANAGE_ENTITY_DTO_ENTITY_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_ID_DESC",
"format":"uuid"
},
"entityName":{
"title":"MANAGE_ENTITY_DTO_ENTITY_NAME_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_NAME_DESC",
"example":"Acme Institution"
},
"entityType":{
"title":"MANAGE_ENTITY_DTO_ENTITY_TYPE_TITLE",
"maxLength":25,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_TYPE_DESC",
"example":"INVESTIGATOR"
},
"entityAction":{
"title":"MANAGE_ENTITY_DTO_ENTITY_ACTION_TITLE",
"maxLength":25,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_ACTION_DESC",
"example":"TRANSFER"
},
"targetTenantEntityId":{
"title":"MANAGE_ENTITY_DTO_TARGET_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_TARGET_ID_DESC",
"format":"uuid"
},
"modes":{
"title":"MANAGE_ENTITY_DTO_MODES_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_MODES_DESC",
"enum":[
"TESTING",
"PRODUCTION",
"TRAINING",
"STUDY_DESIGN"
]
},
"associationId":{
"title":"MANAGE_ENTITY_DTO_ASSOCIATION_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_ASSOCIATION_ID_DESC",
"format":"uuid"
}
},
"description":"MANAGE_ENTITY_DTO_DESC"
}
},
"description":"MANAGE_STUDY_ENTITY_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
},
"description":"ENTITY_MANAGEMENT_REQUEST_DESC"
},
"ManageEntityDto":{
"title":"MANAGE_ENTITY_DTO_TITLE",
"required":[
"entityAction",
"entityType"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"title":"MANAGE_ENTITY_DTO_ENTITY_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_ID_DESC",
"format":"uuid"
},
"entityName":{
"title":"MANAGE_ENTITY_DTO_ENTITY_NAME_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_NAME_DESC",
"example":"Acme Institution"
},
"entityType":{
"title":"MANAGE_ENTITY_DTO_ENTITY_TYPE_TITLE",
"maxLength":25,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_TYPE_DESC",
"example":"INVESTIGATOR"
},
"entityAction":{
"title":"MANAGE_ENTITY_DTO_ENTITY_ACTION_TITLE",
"maxLength":25,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_ACTION_DESC",
"example":"TRANSFER"
},
"targetTenantEntityId":{
"title":"MANAGE_ENTITY_DTO_TARGET_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_TARGET_ID_DESC",
"format":"uuid"
},
"modes":{
"title":"MANAGE_ENTITY_DTO_MODES_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_MODES_DESC",
"enum":[
"TESTING",
"PRODUCTION",
"TRAINING",
"STUDY_DESIGN"
]
},
"associationId":{
"title":"MANAGE_ENTITY_DTO_ASSOCIATION_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_ASSOCIATION_ID_DESC",
"format":"uuid"
}
},
"description":"MANAGE_ENTITY_DTO_DESC"
},
"ManageStudyEntityDto":{
"title":"MANAGE_STUDY_ENTITY_DTO_TITLE",
"required":[
"studyId"
],
"type":"object",
"properties":{
"studyId":{
"title":"MANAGE_STUDY_ENTITY_DTO_STUDY_ID_TITLE",
"type":"string",
"description":"MANAGE_STUDY_ENTITY_DTO_STUDY_ID_DESC",
"format":"uuid"
},
"studyEntities":{
"title":"MANAGE_ENTITY_DTO_TITLE",
"required":[
"entityAction",
"entityType"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"title":"MANAGE_ENTITY_DTO_ENTITY_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_ID_DESC",
"format":"uuid"
},
"entityName":{
"title":"MANAGE_ENTITY_DTO_ENTITY_NAME_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_NAME_DESC",
"example":"Acme Institution"
},
"entityType":{
"title":"MANAGE_ENTITY_DTO_ENTITY_TYPE_TITLE",
"maxLength":25,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_TYPE_DESC",
"example":"INVESTIGATOR"
},
"entityAction":{
"title":"MANAGE_ENTITY_DTO_ENTITY_ACTION_TITLE",
"maxLength":25,
"minLength":0,
"type":"string",
"description":"MANAGE_ENTITY_DTO_ENTITY_ACTION_DESC",
"example":"TRANSFER"
},
"targetTenantEntityId":{
"title":"MANAGE_ENTITY_DTO_TARGET_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_TARGET_ID_DESC",
"format":"uuid"
},
"modes":{
"title":"MANAGE_ENTITY_DTO_MODES_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_MODES_DESC",
"enum":[
"TESTING",
"PRODUCTION",
"TRAINING",
"STUDY_DESIGN"
]
},
"associationId":{
"title":"MANAGE_ENTITY_DTO_ASSOCIATION_ID_TITLE",
"type":"string",
"description":"MANAGE_ENTITY_DTO_ASSOCIATION_ID_DESC",
"format":"uuid"
}
},
"description":"MANAGE_ENTITY_DTO_DESC"
}
},
"description":"MANAGE_STUDY_ENTITY_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"OrganizationDto":{
"title":"ORGANIZATION_DTO_TITLE",
"required":[
"name"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"name":{
"maxLength":500,
"minLength":0,
"type":"string",
"example":"Sample Name"
},
"status":{
"type":"string",
"format":"uuid"
},
"statusCodeValue":{
"title":"ORGANIZATION_DTO_STATUS_CODE_VALUE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_STATUS_CODE_VALUE_DESC",
"example":"Active"
},
"timezone":{
"title":"ORGANIZATION_DTO_TIMEZONE_TITLE",
"type":"string",
"description":"ORGANIZATION_DTO_TIMEZONE_DESC",
"example":"America/New_York"
},
"msaStart":{
"title":"ORGANIZATION_DTO_MSA_START_TITLE",
"type":"string",
"description":"ORGANIZATION_DTO_MSA_START_DESC",
"format":"date-time",
"example":"2025-01-01T00:00:00Z"
},
"msaEnd":{
"title":"ORGANIZATION_DTO_MSA_END_TITLE",
"type":"string",
"description":"ORGANIZATION_DTO_MSA_END_DESC",
"format":"date-time",
"example":"2026-01-01T00:00:00Z"
},
"orgType":{
"type":"string",
"format":"uuid"
},
"orgTypeCodeValue":{
"title":"ORGANIZATION_DTO_ORG_TYPE_CODE_VALUE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_ORG_TYPE_CODE_VALUE_DESC",
"example":"ORG_TYPE_CODE"
},
"categoryType":{
"type":"string",
"format":"uuid"
},
"categoryTypeCodeValue":{
"title":"ORGANIZATION_DTO_CATEGORY_TYPE_CODE_VALUE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_CATEGORY_TYPE_CODE_VALUE_DESC",
"example":"CATEGORY_CODE"
},
"orgId":{
"title":"ORGANIZATION_DTO_ORG_ID_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_ORG_ID_DESC",
"example":"ORG-12345"
},
"subType":{
"type":"string",
"format":"uuid"
},
"subTypeCodeValue":{
"title":"ORGANIZATION_DTO_SUB_TYPE_CODE_VALUE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_SUB_TYPE_CODE_VALUE_DESC",
"example":"SUB_TYPE"
},
"msa":{
"title":"ORGANIZATION_DTO_MSA_TITLE",
"maxLength":1,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_MSA_DESC",
"example":"Y"
},
"taxId":{
"title":"ORGANIZATION_DTO_TAX_ID_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_TAX_ID_DESC",
"example":"TAX-12345"
},
"vatId":{
"title":"ORGANIZATION_DTO_VAT_ID_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"ORGANIZATION_DTO_VAT_ID_DESC",
"example":"VAT-67890"
},
"webUrl":{
"title":"ORGANIZATION_DTO_WEB_URL_TITLE",
"maxLength":255,
"minLength":0,
"pattern":"[(http(s)?):\\/\\/(www\\.)?a-zA-Z0-9@:%._\\+~#=]{2,256}\\.[a-z]{2,6}\\b([-a-zA-Z0-9@:%_\\+.~#?&//=]*)",
"type":"string",
"description":"ORGANIZATION_DTO_WEB_URL_DESC",
"example":"https://acme.example.com"
}
},
"description":"ORGANIZATION_DTO_DESC",
"example":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"name":"Acme CRO"
}
},
"OrganizationModelDto":{
"title":"ORGANIZATION_MODEL_TITLE",
"required":[
"modes",
"orgAddressesDetails",
"organization"
],
"type":"object",
"properties":{
"organization":{
"$ref":"#/components/schemas/OrganizationDto"
},
"properties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"orgAddressesDetails":{
"title":"EntityAddressAssociationDto",
"required":[
"addressPostalcode"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Address Association ID",
"type":"string",
"description":"Unique identifier for the entity address association.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"entityId":{
"title":"Entity ID",
"type":"string",
"description":"Identifier of the entity owning the address.",
"format":"uuid"
},
"mainPrimary":{
"title":"Main Primary Flag",
"type":"boolean",
"description":"Indicates if this is the main primary address.",
"example":true
},
"entityType":{
"title":"Entity Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of entity for the address.",
"example":"Contact"
},
"addressType":{
"title":"Address Type",
"type":"string",
"description":"Identifier for the address type.",
"format":"uuid"
},
"addressTypeCodeValue":{
"title":"Address Type Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the address type.",
"example":"Primary"
},
"country":{
"title":"Country ID",
"type":"string",
"description":"Identifier for the country.",
"format":"uuid"
},
"countryCodeValue":{
"title":"Country Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the country code.",
"example":"USA"
},
"addressPostalcode":{
"title":"Postal Code",
"maxLength":20,
"minLength":0,
"type":"string",
"description":"Postal code for the address.",
"example":"80202"
},
"addressProperties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
},
"addressStreet1":{
"type":"string"
},
"addressStreet2":{
"type":"string"
},
"addressCity":{
"type":"string"
},
"addressStateOrProvOrCounty":{
"type":"string",
"format":"uuid"
},
"addressStateOrProvOrCountyCodeValue":{
"type":"string"
}
},
"description":"Represents an address linked to an entity.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"modes":{
"title":"ModeDto",
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Mode ID",
"type":"string",
"description":"Unique identifier for the mode assignment.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"entityId":{
"title":"Entity ID",
"type":"string",
"description":"Identifier of the associated entity.",
"format":"uuid"
},
"entityType":{
"title":"Entity Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of entity tied to the mode.",
"example":"Contact"
},
"mode":{
"title":"Mode",
"type":"string",
"description":"Identifier of the mode.",
"format":"uuid"
},
"modeCodeValue":{
"title":"Mode Code Value",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Display value for the mode.",
"example":"Operational"
}
},
"description":"Represents a mode assignment for an entity.",
"example":[
"test"
]
}
},
"description":"ORGANIZATION_MODEL_DESC"
},
"Organizations":{
"required":[
"name",
"orgId",
"orgType",
"status",
"studyAgnostic",
"studyId"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the latest change made to this record.",
"example":"Protocol update requested by study operations."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional user comment about the latest change.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"description":"Unique identifier for this record.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"Timestamp when this version became active.",
"format":"date-time",
"example":"2026-03-16T12:00:00Z"
},
"orgType":{
"type":"string",
"description":"Represents org type for this record.",
"format":"uuid"
},
"subType":{
"type":"string",
"description":"Represents sub type for this record.",
"format":"uuid"
},
"name":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Name value for this record.",
"example":"Sample Name"
},
"categoryType":{
"type":"string",
"description":"Represents category type for this record.",
"format":"uuid"
},
"orgId":{
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Represents org id for this record.",
"example":"SITE-001"
},
"status":{
"type":"string",
"description":"Represents status for this record.",
"format":"uuid"
},
"timezone":{
"type":"string",
"description":"Represents timezone for this record.",
"example":"UTC"
},
"webUrl":{
"maxLength":255,
"minLength":0,
"pattern":"[(http(s)?):\\/\\/(www\\.)?a-zA-Z0-9@:%._\\+~#=]{2,256}\\.[a-z]{2,6}\\b([-a-zA-Z0-9@:%_\\+.~#?&//=]*)",
"type":"string",
"description":"Represents web url for this record.",
"example":"https://example.org"
},
"msa":{
"maxLength":5,
"minLength":0,
"type":"string",
"description":"Represents msa for this record.",
"example":"Sample Value"
},
"msaStart":{
"type":"string",
"description":"Represents msa start for this record.",
"format":"date-time",
"example":"2026-03-16T12:00:00Z"
},
"msaEnd":{
"type":"string",
"description":"Represents msa end for this record.",
"format":"date-time",
"example":"2026-03-16T12:00:00Z"
},
"taxId":{
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Represents tax id for this record.",
"example":"Sample Value"
},
"vatId":{
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Represents vat id for this record.",
"example":"Sample Value"
},
"studyId":{
"type":"string",
"description":"Identifier of the related study.",
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
"studyAgnostic":{
"type":"string",
"description":"Represents study agnostic for this record.",
"example":"N"
},
"statusCodeValue":{
"type":"string",
"description":"Display value for the status code.",
"example":"ACTIVE"
},
"orgTypeCodeValue":{
"type":"string",
"description":"Represents org type code value for this record.",
"example":"SITE"
},
"categoryTypeCodeValue":{
"type":"string",
"description":"Represents category type code value for this record.",
"example":"SITE"
},
"subTypeCodeValue":{
"type":"string",
"description":"Represents sub type code value for this record.",
"example":"SITE"
}
}
},
"OrganizationFieldsDto":{
"title":"ORGANIZATION_FIELDS_TITLE",
"type":"object",
"properties":{
"organizationFields":{
"title":"Field",
"type":"object",
"properties":{
"fieldName":{
"title":"Field Name",
"type":"string",
"description":"Field name. The acceptable values are: TENANTID, STUDYID, COUNTRY, SITEID, INVID, INVNAM, USUBJID, SCRNID, SUBJID, VISITNUM, VISIT, UNSCHED, SVSTDTC, DOMAIN, LAB ID, LAB NAME, REPEATNUMBER, SREPEATID, SREPEATNUMBER, ENTERED BY, ENTERED DATE, LAST CHANGED BY, LAST CHANGED DATE etc.",
"example":"TENANTID"
},
"fieldValue":{
"title":"Field Value",
"type":"string",
"description":"Value reported for the field.",
"example":"TENANT123"
},
"valueExists":{
"title":"Value Exists",
"type":"boolean",
"description":"Indicates whether the value already exists.",
"example":true
}
},
"description":"Contains field details.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
},
"description":"ORGANIZATION_FIELDS_DESC"
},
"TenantSiteDto":{
"title":"TENANT_SITE_DTO_TITLE",
"required":[
"tenantFirstEntityId",
"tenantSecondEntityId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"TENANT_SITE_DTO_ID_TITLE",
"type":"string",
"description":"TENANT_SITE_DTO_ID_DESC",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"tenantFirstEntityId":{
"title":"TENANT_SITE_DTO_FIRST_ENTITY_ID_TITLE",
"type":"string",
"description":"TENANT_SITE_DTO_FIRST_ENTITY_ID_DESC",
"format":"uuid"
},
"tenantSecondEntityId":{
"title":"TENANT_SITE_DTO_SECOND_ENTITY_ID_TITLE",
"type":"string",
"description":"TENANT_SITE_DTO_SECOND_ENTITY_ID_DESC",
"format":"uuid"
}
},
"description":"TENANT_SITE_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"TenantSitesRequest":{
"title":"TENANT_SITES_REQUEST_TITLE",
"type":"object",
"properties":{
"tenantSites":{
"title":"TENANT_SITE_DTO_TITLE",
"required":[
"tenantFirstEntityId",
"tenantSecondEntityId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"TENANT_SITE_DTO_ID_TITLE",
"type":"string",
"description":"TENANT_SITE_DTO_ID_DESC",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"tenantFirstEntityId":{
"title":"TENANT_SITE_DTO_FIRST_ENTITY_ID_TITLE",
"type":"string",
"description":"TENANT_SITE_DTO_FIRST_ENTITY_ID_DESC",
"format":"uuid"
},
"tenantSecondEntityId":{
"title":"TENANT_SITE_DTO_SECOND_ENTITY_ID_TITLE",
"type":"string",
"description":"TENANT_SITE_DTO_SECOND_ENTITY_ID_DESC",
"format":"uuid"
}
},
"description":"TENANT_SITE_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
},
"description":"TENANT_SITES_REQUEST_DESC"
},
"CreateStudySitesDto":{
"title":"CREATE_STUDY_SITES_DTO_TITLE",
"required":[
"modeId",
"siteIdName",
"studyId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"CREATE_STUDY_SITES_DTO_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_ID_DESC",
"format":"uuid"
},
"studyId":{
"title":"CREATE_STUDY_SITES_DTO_STUDY_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_STUDY_ID_DESC",
"format":"uuid"
},
"modeId":{
"title":"CREATE_STUDY_SITES_DTO_MODE_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_MODE_ID_DESC",
"format":"uuid"
},
"siteIdName":{
"title":"CREATE_STUDY_SITES_DTO_SITE_ID_NAME_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_SITE_ID_NAME_DESC",
"example":"SITE-123"
},
"statusId":{
"title":"CREATE_STUDY_SITES_DTO_STATUS_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_STATUS_ID_DESC",
"format":"uuid"
}
},
"description":"CREATE_STUDY_SITES_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"StudySitesRequest":{
"title":"STUDY_SITES_REQUEST_TITLE",
"type":"object",
"properties":{
"studySites":{
"title":"CREATE_STUDY_SITES_DTO_TITLE",
"required":[
"modeId",
"siteIdName",
"studyId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"CREATE_STUDY_SITES_DTO_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_ID_DESC",
"format":"uuid"
},
"studyId":{
"title":"CREATE_STUDY_SITES_DTO_STUDY_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_STUDY_ID_DESC",
"format":"uuid"
},
"modeId":{
"title":"CREATE_STUDY_SITES_DTO_MODE_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_MODE_ID_DESC",
"format":"uuid"
},
"siteIdName":{
"title":"CREATE_STUDY_SITES_DTO_SITE_ID_NAME_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_SITE_ID_NAME_DESC",
"example":"SITE-123"
},
"statusId":{
"title":"CREATE_STUDY_SITES_DTO_STATUS_ID_TITLE",
"type":"string",
"description":"CREATE_STUDY_SITES_DTO_STATUS_ID_DESC",
"format":"uuid"
}
},
"description":"CREATE_STUDY_SITES_DTO_DESC",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
},
"description":"STUDY_SITES_REQUEST_DESC"
},
"ReasonForInvalidAssociationTO":{
"title":"REASON_FOR_INVALID_ASSOCIATION_TITLE",
"type":"object",
"properties":{
"context":{
"title":"REASON_FOR_INVALID_ASSOCIATION_CONTEXT_TITLE",
"type":"string",
"description":"REASON_FOR_INVALID_ASSOCIATION_CONTEXT_DESC",
"example":"entityType"
},
"message":{
"title":"REASON_FOR_INVALID_ASSOCIATION_MESSAGE_TITLE",
"type":"string",
"description":"REASON_FOR_INVALID_ASSOCIATION_MESSAGE_DESC",
"example":"Entity not valid for transfer"
}
},
"description":"REASON_FOR_INVALID_ASSOCIATION_DESC",
"example":"Invalid association for selected entities."
},
"TenantSitesDetailsResponse":{
"title":"TENANT_SITES_DETAILS_RESPONSE_TITLE",
"type":"object",
"properties":{
"reason":{
"title":"TENANT_SITES_DETAILS_RESPONSE_REASON_TITLE",
"type":"string",
"description":"TENANT_SITES_DETAILS_RESPONSE_REASON_DESC",
"example":"Association active"
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Identifier of the user who performed the audited action.",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"tenantFirstEntityId":{
"type":"string",
"format":"uuid"
},
"tenantSecondEntityId":{
"type":"string",
"format":"uuid"
},
"associationId":{
"type":"string",
"format":"uuid"
},
"tenantFirstEntityName":{
"title":"TENANT_SITES_DETAILS_RESPONSE_FIRST_ENTITY_NAME_TITLE",
"type":"string",
"description":"TENANT_SITES_DETAILS_RESPONSE_FIRST_ENTITY_NAME_DESC",
"example":"Acme Research"
},
"tenantSecondEntityName":{
"title":"TENANT_SITES_DETAILS_RESPONSE_SECOND_ENTITY_NAME_TITLE",
"type":"string",
"description":"TENANT_SITES_DETAILS_RESPONSE_SECOND_ENTITY_NAME_DESC",
"example":"Beta Institution"
},
"studySitesCount":{
"title":"TENANT_SITES_DETAILS_RESPONSE_STUDY_SITES_COUNT_TITLE",
"type":"integer",
"description":"TENANT_SITES_DETAILS_RESPONSE_STUDY_SITES_COUNT_DESC",
"format":"int32",
"example":5
},
"tenantFirstEntityStatus":{
"type":"string",
"format":"uuid"
},
"tenantSecondEntityStatus":{
"type":"string",
"format":"uuid"
},
"reasonForInvalidAssoc":{
"title":"REASON_FOR_INVALID_ASSOCIATION_TITLE",
"type":"object",
"properties":{
"context":{
"title":"REASON_FOR_INVALID_ASSOCIATION_CONTEXT_TITLE",
"type":"string",
"description":"REASON_FOR_INVALID_ASSOCIATION_CONTEXT_DESC",
"example":"entityType"
},
"message":{
"title":"REASON_FOR_INVALID_ASSOCIATION_MESSAGE_TITLE",
"type":"string",
"description":"REASON_FOR_INVALID_ASSOCIATION_MESSAGE_DESC",
"example":"Entity not valid for transfer"
}
},
"description":"REASON_FOR_INVALID_ASSOCIATION_DESC",
"example":"Invalid association for selected entities."
},
"modes":{
"type":"array",
"example":[
"B1B8327AFAA6412287106192AB5984EF"
],
"items":{
"type":"string",
"format":"uuid"
}
},
"valid":{
"type":"boolean",
"example":true
}
},
"description":"TENANT_SITES_DETAILS_RESPONSE_DESC"
},
"EntityAddressAssociationResponse":{
"title":"ENTITY_ADDRESS_ASSOCIATION_RESPONSE_TITLE",
"type":"object",
"properties":{
"entityAddressAssociations":{
"title":"EntityAddressAssociationDto",
"required":[
"addressPostalcode"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Address Association ID",
"type":"string",
"description":"Unique identifier for the entity address association.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"entityId":{
"title":"Entity ID",
"type":"string",
"description":"Identifier of the entity owning the address.",
"format":"uuid"
},
"mainPrimary":{
"title":"Main Primary Flag",
"type":"boolean",
"description":"Indicates if this is the main primary address.",
"example":true
},
"entityType":{
"title":"Entity Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of entity for the address.",
"example":"Contact"
},
"addressType":{
"title":"Address Type",
"type":"string",
"description":"Identifier for the address type.",
"format":"uuid"
},
"addressTypeCodeValue":{
"title":"Address Type Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the address type.",
"example":"Primary"
},
"country":{
"title":"Country ID",
"type":"string",
"description":"Identifier for the country.",
"format":"uuid"
},
"countryCodeValue":{
"title":"Country Code",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Display value for the country code.",
"example":"USA"
},
"addressPostalcode":{
"title":"Postal Code",
"maxLength":20,
"minLength":0,
"type":"string",
"description":"Postal code for the address.",
"example":"80202"
},
"addressProperties":{
"title":"PROPERTY_DTO_TITLE",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"entityId":{
"type":"string",
"description":"ENTITY_ID_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"entityType":{
"title":"PROPERTY_DTO_ENTITY_TYPE_TITLE",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_ENTITY_TYPE_DESC",
"example":"INSTITUTION"
},
"propertyName":{
"title":"PROPERTY_DTO_NAME_TITLE",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_NAME_DESC",
"example":"LabId"
},
"propertyValue":{
"title":"PROPERTY_DTO_VALUE_TITLE",
"maxLength":500,
"minLength":0,
"type":"string",
"description":"PROPERTY_DTO_VALUE_DESC",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
}
},
"description":"PROPERTY_DTO_DESC"
},
"addressStreet1":{
"type":"string"
},
"addressStreet2":{
"type":"string"
},
"addressCity":{
"type":"string"
},
"addressStateOrProvOrCounty":{
"type":"string",
"format":"uuid"
},
"addressStateOrProvOrCountyCodeValue":{
"type":"string"
}
},
"description":"Represents an address linked to an entity.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
}
},
"description":"ENTITY_ADDRESS_ASSOCIATION_RESPONSE_DESC"
},
"ValidTenantSitesDetailsResponse":{
"title":"VALID_TENANT_SITES_DETAILS_RESPONSE_TITLE",
"type":"object",
"properties":{
"tenantFirstEntityId":{
"type":"string",
"format":"uuid"
},
"tenantSecondEntityId":{
"type":"string",
"format":"uuid"
},
"associationId":{
"type":"string",
"format":"uuid"
},
"modes":{
"type":"array",
"example":[
"B1B8327AFAA6412287106192AB5984EF"
],
"items":{
"type":"string",
"format":"uuid"
}
},
"tenantFirstEntityName":{
"title":"VALID_TENANT_SITES_DETAILS_RESPONSE_FIRST_ENTITY_NAME_TITLE",
"type":"string",
"description":"VALID_TENANT_SITES_DETAILS_RESPONSE_FIRST_ENTITY_NAME_DESC",
"example":"Acme Research"
},
"tenantSecondEntityName":{
"title":"VALID_TENANT_SITES_DETAILS_RESPONSE_SECOND_ENTITY_NAME_TITLE",
"type":"string",
"description":"VALID_TENANT_SITES_DETAILS_RESPONSE_SECOND_ENTITY_NAME_DESC",
"example":"Beta Institution"
},
"institutionTimezone":{
"title":"VALID_TENANT_SITES_DETAILS_RESPONSE_TIMEZONE_TITLE",
"type":"string",
"description":"VALID_TENANT_SITES_DETAILS_RESPONSE_TIMEZONE_DESC",
"example":"America/New_York"
},
"tenantFirstEntityPrimaryCity":{
"title":"VALID_TENANT_SITES_DETAILS_RESPONSE_PRIMARY_CITY_TITLE",
"type":"string",
"description":"VALID_TENANT_SITES_DETAILS_RESPONSE_PRIMARY_CITY_DESC",
"example":"Metropolis"
},
"tenantFirstEntityPrimaryState":{
"type":"string",
"format":"uuid"
},
"tenantFirstEntityPrimaryCountry":{
"type":"string",
"format":"uuid"
}
},
"description":"VALID_TENANT_SITES_DETAILS_RESPONSE_DESC"
},
"ContactOrganizationDeleteReasonDtoV2":{
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"reasonForDelete":{
"title":"ReasonForDelete",
"type":"string",
"description":"Reason explaining why the delete operation is requested.",
"example":"No longer active"
},
"commentForOther":{
"type":"string",
"example":"Closed due to site transfer."
}
}
},
"PaginatedResponseDto":{
"title":"PaginatedResponseDto",
"type":"object",
"properties":{
"hasMore":{
"maxLength":5,
"minLength":4,
"type":"string",
"description":"Attribute describes if result set has more records Returns \"true\" when additional records exist, otherwise \"false\".",
"example":"true",
"enum":[
"true",
"false"
]
},
"totalResults":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"Total number of entities in response Provide a non-negative integer.",
"format":"int32",
"example":5
},
"count":{
"maximum":5000,
"minimum":0,
"type":"integer",
"description":"Total count of result Provide a non-negative integer.",
"format":"int32",
"example":5
},
"limit":{
"maximum":5000,
"minimum":1,
"type":"integer",
"description":"Maximum number of records to display per page. Provide a value between 1 and 5000 inclusive.",
"format":"int32",
"example":5
},
"offset":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter. Provide a zero or positive value.",
"format":"int32",
"example":400
},
"columns":{
"type":"array",
"example":[
"name",
"status"
],
"items":{
"type":"string",
"example":"[\"name\",\"status\"]"
}
},
"data":{
"type":"array",
"description":"Tabular data where each item is a row represented as an array of string values that align with the columns order.",
"example":[
[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved"
]
],
"items":{
"type":"array",
"description":"Row values aligned with the `columns` list; each row must include between 1 and 50 string columns.",
"example":[
"38891F5E75BB4071BBF8ACE1F43BD1BD",
"Visit Start Date Validation",
"approved"
],
"items":{
"type":"string",
"description":"Row values aligned with the `columns` list; each row must include between 1 and 50 string columns.",
"example":"[\"38891F5E75BB4071BBF8ACE1F43BD1BD\",\"Visit Start Date Validation\",\"approved\"]"
}
}
}
},
"description":"Paginated Response Object for report APIs."
},
"SDFPropertyDto":{
"title":"SDFPropertyDto v1.0",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Property ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the property entry.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF the property belongs to.",
"format":"uuid"
},
"propertyName":{
"title":"Property Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Key identifying the property.",
"example":"PRIMARY_CONTACT"
},
"propertyValue":{
"title":"Property Value",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Value stored for the property.",
"example":"ACTIVE"
}
},
"description":"Property metadata attached to an SDF.",
"example":[
{
"propertyName":"PRIMARY",
"propertyValue":"ACTIVE"
}
]
},
"SDFPropertyResponse":{
"type":"object",
"properties":{
"sdfPropertyList":{
"type":"array",
"description":"List of SDF properties.",
"example":[
{
"propertyName":"timezone",
"propertyValue":"UTC"
}
],
"items":{
"$ref":"#/components/schemas/SDFPropertyDto"
}
}
}
},
"SDFExtendedPropReq":{
"type":"object",
"properties":{
"extendedProperties":{
"type":"array",
"description":"Collection of extended properties for update operations.",
"example":[
{
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
}
}
},
"SDFsPropertyDto":{
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"description":"Unique identifier for this record.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"type":"string",
"description":"Identifier of the related SDF record.",
"format":"uuid"
},
"propertyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the property.",
"example":"timezone"
},
"propertyValue":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Value of the property.",
"example":"UTC"
}
}
},
"SDFGlobalPropertiesRequest":{
"type":"object",
"properties":{
"globalProperties":{
"type":"array",
"description":"Collection of global properties for update or create operations.",
"example":[
{
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
}
}
},
"SDFKitSettingDto":{
"required":[
"kitTypeId",
"settingName",
"settingValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"sdfId":{
"type":"string",
"format":"uuid"
},
"kitTypeId":{
"type":"string",
"format":"uuid"
},
"settingName":{
"type":"string",
"example":"PRIMARY_COUNTRY"
},
"settingValue":{
"type":"string",
"example":"sample"
},
"settingOperationType":{
"type":"string",
"writeOnly":true
}
},
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"SDFKitSettingsResponse":{
"type":"object",
"properties":{
"sdfKitSettings":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFKitSettingDto"
}
}
}
},
"SDFKitSettingsRequest":{
"type":"object",
"properties":{
"sdfKitSettings":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFKitSettingDto"
}
}
}
},
"SDFAddressAssociationDto":{
"required":[
"entityAddressAssociationId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"sdfId":{
"type":"string",
"format":"uuid"
},
"addressTypeId":{
"type":"string",
"format":"uuid"
},
"addressTypeIdCodeValue":{
"maxLength":50,
"minLength":0,
"type":"string",
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
"entityAddressAssociationId":{
"type":"string",
"format":"uuid"
},
"sdfAddressProperties":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
},
"mainPrimary":{
"type":"boolean",
"example":true
}
}
},
"SDFCreateUpdateResponse":{
"type":"object",
"properties":{
"sdf":{
"$ref":"#/components/schemas/SDFDto"
},
"sdfPropertyList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
},
"sdfAddressAssociations":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFAddressAssociationDto"
}
}
}
},
"SDFDto":{
"title":"SDFDto v1.0",
"required":[
"name",
"sdfType",
"status",
"studyOrgId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the SDF record.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"name":{
"title":"Name",
"maxLength":200,
"minLength":0,
"type":"string",
"description":"Official name of the site or depot.",
"example":"Oakland Biomed Site"
},
"status":{
"title":"Status",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Current status of the SDF, for example Active or Inactive.",
"example":"ACTIVE"
},
"sdfType":{
"title":"SDF Type",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Role of the SDF such as Site or Depot.",
"example":"SITE"
},
"studyOrgId":{
"title":"Study Organization ID",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Identifier of the study organization linked to the SDF.",
"example":"STUDY-123"
}
},
"description":"Metadata for a study site or depot.",
"example":{
"id":"3F2504E04F8911D39A0C0305E82C3301",
"name":"Oakland Biomed Site",
"status":"ACTIVE",
"sdfType":"SITE",
"studyOrgId":"STUDY-123"
}
},
"SDFCreateUpdateRequest":{
"type":"object",
"properties":{
"sdf":{
"$ref":"#/components/schemas/SDFDto"
},
"sdfPropertyList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
},
"sdfAddressAssociations":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFAddressAssociationDto"
}
}
}
},
"DepotDetailsDto":{
"type":"object",
"allOf":[
{
"$ref":"#/components/schemas/SDFDetailsDto"
},
{
"type":"object",
"properties":{
"sdfCountriesList":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SDFCountryDetailsDto"
}
},
"vendorDepotId":{
"type":"string",
"format":"uuid"
},
"vendorDepotName":{
"type":"string"
},
"institutionId":{
"type":"string",
"format":"uuid"
},
"institutionName":{
"type":"string"
},
"vendorDepotStatus":{
"type":"string",
"format":"uuid"
},
"institutionStatus":{
"type":"string",
"format":"uuid"
}
}
}
]
},
"DepotDetailsDtoV2":{
"type":"object",
"allOf":[
{
"$ref":"#/components/schemas/SDFDetailsDto"
},
{
"type":"object",
"properties":{
"sdfCountriesList":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SDFCountryDetailsDto"
}
},
"vendorDepotId":{
"type":"string",
"format":"uuid"
},
"vendorDepotName":{
"type":"string"
},
"institutionId":{
"type":"string",
"format":"uuid"
},
"institutionName":{
"type":"string"
},
"vendorDepotStatus":{
"type":"string",
"format":"uuid"
},
"institutionStatus":{
"type":"string",
"format":"uuid"
},
"vendorTimeZone":{
"type":"string"
}
}
}
]
},
"SDFAddressAssociationDetailsDto":{
"required":[
"addressTypeId",
"entityAddressAssociationId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Identifier of the user who performed the audited action.",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"sdfId":{
"type":"string",
"format":"uuid"
},
"addressTypeId":{
"type":"string",
"format":"uuid"
},
"addressTypeIdCodeValue":{
"type":"string",
"example":"C36A3197FDEE433FB5547EE83DE99E4B"
},
"entityAddressAssociationId":{
"type":"string",
"format":"uuid"
},
"addressStreet1":{
"type":"string",
"example":"sample"
},
"addressStreet2":{
"type":"string",
"example":"sample"
},
"addressCity":{
"type":"string",
"example":"sample"
},
"addressPostalCode":{
"type":"string",
"example":"sample"
},
"addressStateOrProvOrCounty":{
"type":"string",
"format":"uuid"
},
"addressStateOrProvOrCountyName":{
"type":"string",
"example":"California"
},
"addressCountry":{
"type":"string",
"format":"uuid"
},
"addressCountryName":{
"type":"string",
"example":"United States"
},
"entityAddressProperties":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/PropertyDto"
}
},
"sdfAddressProperties":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFPropertyDetailsDto"
}
}
},
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"SDFCountryDetailsDto":{
"title":"SDFCountryDetailsDto v1.0",
"required":[
"countryId",
"primarySupply",
"sdfId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Identifier of the user who performed the audited action.",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"id":{
"title":"SDF Country Details ID",
"type":"string",
"description":"Unique identifier for the CTMS SDF country details record.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Raw(16) country UUID linked to the SDF record.",
"format":"uuid"
},
"stateId":{
"title":"State ID",
"type":"string",
"description":"Raw(16) state UUID linked to the SDF record.",
"format":"uuid"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"SDF identifier for the CTMS association.",
"format":"uuid"
},
"primarySupply":{
"title":"Primary Supply",
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Primary supply type for the SDF-country association.",
"example":"DOMESTIC"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Official name of the country.",
"example":"United States"
},
"stateName":{
"title":"State Name",
"type":"string",
"description":"Name of the state associated with the SDF.",
"example":"California"
}
},
"description":"CTMS/SDF country details returned by the paginated endpoint."
},
"SDFDetailsDto":{
"required":[
"sdfType"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Identifier of the user who performed the audited action.",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"tenantEntityId":{
"type":"string",
"format":"uuid"
},
"studyOrgIdName":{
"type":"string",
"example":"Primary Site Org"
},
"statusId":{
"type":"string",
"format":"uuid"
},
"statusIdCodeValue":{
"type":"string",
"example":"ACTIVE"
},
"oldSdfId":{
"type":"string",
"format":"uuid"
},
"sdfType":{
"type":"string"
}
},
"example":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"tenantEntityId":"B1B8327AFAA6412287106192AB5984EF",
"statusId":"B1B8327AFAA6412287106192AB5984EF",
"sdfType":"Site"
},
"discriminator":{
"propertyName":"sdfType"
}
},
"SDFDetailsResponse":{
"type":"object",
"properties":{
"sdf":{
"$ref":"#/components/schemas/SDFDetailsDto"
},
"sdfPropertyList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFPropertyDetailsDto"
}
},
"sdfAddressAssociations":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFAddressAssociationDetailsDto"
}
},
"sdfKitSettingDto":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFKitSettingDto"
}
}
}
},
"SDFPropertyDetailsDto":{
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Identifier of the user who performed the audited action.",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"sdfId":{
"type":"string",
"format":"uuid"
},
"propertyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"example":"Sample Name"
},
"propertyValue":{
"maxLength":1024,
"minLength":0,
"type":"string",
"example":"sample"
}
},
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"SiteDetailsDto":{
"type":"object",
"allOf":[
{
"$ref":"#/components/schemas/SDFDetailsDto"
},
{
"type":"object",
"properties":{
"contactId":{
"type":"string",
"format":"uuid"
},
"institutionId":{
"type":"string",
"format":"uuid"
},
"contactFirstName":{
"type":"string"
},
"contactLastName":{
"type":"string"
},
"contactMiddleName":{
"type":"string"
},
"contactSuffix":{
"type":"string",
"format":"uuid"
},
"contactSuffixCodeValue":{
"type":"string"
},
"contactPrefix":{
"type":"string",
"format":"uuid"
},
"contactPrefixCodeValue":{
"type":"string"
},
"contactDegree":{
"type":"string"
},
"institutionName":{
"type":"string"
},
"contactStatus":{
"type":"string",
"format":"uuid"
},
"contactStatusCodeValue":{
"type":"string"
},
"institutionStatus":{
"type":"string",
"format":"uuid"
},
"institutionStatusCodeValue":{
"type":"string"
}
}
}
]
},
"SiteDetailsDtoV2":{
"type":"object",
"allOf":[
{
"$ref":"#/components/schemas/SDFDetailsDto"
},
{
"type":"object",
"properties":{
"contactId":{
"type":"string",
"format":"uuid"
},
"institutionId":{
"type":"string",
"format":"uuid"
},
"contactFirstName":{
"type":"string"
},
"contactLastName":{
"type":"string"
},
"contactMiddleName":{
"type":"string"
},
"contactSuffix":{
"type":"string",
"format":"uuid"
},
"contactSuffixCodeValue":{
"type":"string"
},
"contactPrefix":{
"type":"string",
"format":"uuid"
},
"contactPrefixCodeValue":{
"type":"string"
},
"contactDegree":{
"type":"string"
},
"institutionName":{
"type":"string"
},
"contactStatus":{
"type":"string",
"format":"uuid"
},
"contactStatusCodeValue":{
"type":"string"
},
"institutionStatus":{
"type":"string",
"format":"uuid"
},
"institutionStatusCodeValue":{
"type":"string"
},
"institutionTimeZone":{
"type":"string"
}
}
}
]
},
"SDFProperty":{
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for the latest change made to this record.",
"example":"Protocol update requested by study operations."
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional user comment about the latest change.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"description":"Unique identifier for this record.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"description":"Identifier of the related SDF record.",
"format":"uuid"
},
"propertyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the property.",
"example":"timezone"
},
"propertyValue":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Value of the property.",
"example":"UTC"
}
}
},
"DepotInfoDto":{
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"id":{
"type":"string",
"description":"Unique identifier for this record.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"Timestamp when this version became active.",
"format":"date-time",
"example":"2026-03-16T12:00:00Z"
},
"vendorId":{
"type":"string",
"description":"Identifier of the related vendor.",
"format":"uuid"
},
"studyOrgIdName":{
"type":"string",
"description":"Study organization identifier or name used for display.",
"example":"Sample Name"
},
"statusId":{
"type":"string",
"description":"Identifier of the status code.",
"format":"uuid"
},
"statusCodeValue":{
"type":"string",
"description":"Display value for the status code.",
"example":"ACTIVE"
},
"vendorName":{
"type":"string",
"description":"Represents vendor name for this record.",
"example":"Sample Name"
},
"mode":{
"type":"string",
"description":"Mode identifier associated with this record.",
"format":"uuid"
},
"oldSdfId":{
"type":"string",
"description":"Identifier of the previous SDF record, when applicable.",
"format":"uuid"
}
}
},
"SiteDepotIdsList":{
"required":[
"depotIds",
"siteIds"
],
"type":"object",
"properties":{
"siteIds":{
"type":"array",
"example":[
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"items":{
"type":"string",
"format":"uuid"
}
},
"depotIds":{
"type":"array",
"example":[
"C36A3197FDEE433FB5547EE83DE99E4B"
],
"items":{
"type":"string",
"format":"uuid"
}
}
}
},
"SDFExtendedPropertiesListResponse":{
"type":"object",
"properties":{
"sdfExtendedPropertiesList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFPropertyListDto"
}
}
}
},
"SDFPropertyListDto":{
"type":"object",
"properties":{
"sdfId":{
"type":"string",
"format":"uuid"
},
"sdfPropertyList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
}
},
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
]
},
"SDFUpdateStatusDto":{
"required":[
"sdfId",
"statusId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"sdfId":{
"type":"string",
"format":"uuid"
},
"statusId":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
}
},
"example":[
"ACTIVE"
]
},
"SDFUpdateStatusResponse":{
"type":"object",
"properties":{
"sdfstatuses":{
"type":"array",
"example":"[{\\\"sdfId\\\":\\\"B1B8327AFAA6412287106192AB5984EF\\\",\\\"statusId\\\":\\\"B1B8327AFAA6412287106192AB5984EF\\\",\\\"versionStart\\\":\\\"2026-01-15T10:30:00Z\\\"}]",
"items":{
"$ref":"#/components/schemas/SDFUpdateStatusDto"
}
}
}
},
"SDFUpdateStatusRequest":{
"type":"object",
"properties":{
"sdfStatuses":{
"type":"array",
"example":[
"ACTIVE"
],
"items":{
"$ref":"#/components/schemas/SDFUpdateStatusDto"
}
}
}
},
"SDFPrimaryCountryResponse":{
"type":"object",
"properties":{
"countries":{
"type":"array",
"example":"[\\\"B1B8327AFAA6412287106192AB5984EF\\\"]",
"items":{
"type":"string",
"format":"uuid"
}
}
}
},
"SDFPrimaryCountryRequest":{
"type":"object",
"properties":{
"countries":{
"type":"array",
"example":"[\\\"B1B8327AFAA6412287106192AB5984EF\\\"]",
"items":{
"type":"string",
"format":"uuid"
}
}
}
},
"SDFFieldsDto":{
"type":"object",
"properties":{
"sdfFields":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/Field"
}
}
}
},
"SiteDetailsLiteDto":{
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Identifier of the user who performed the audited action.",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"id":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
},
"tenantEntityId":{
"type":"string",
"format":"uuid"
},
"studyOrgIdName":{
"type":"string",
"example":"Primary Site Org"
},
"statusId":{
"type":"string",
"format":"uuid"
},
"statusIdCodeValue":{
"type":"string",
"example":"ACTIVE"
},
"oldSdfId":{
"type":"string",
"format":"uuid"
},
"institutionId":{
"type":"string",
"format":"uuid"
},
"institutionName":{
"type":"string",
"example":"City Hospital"
}
},
"example":{
"id":"B1B8327AFAA6412287106192AB5984EF",
"tenantEntityId":"B1B8327AFAA6412287106192AB5984EF",
"statusId":"B1B8327AFAA6412287106192AB5984EF",
"oldSdfId":"B1B8327AFAA6412287106192AB5984EF"
}
},
"StudySiteLiteResponse":{
"type":"object",
"properties":{
"site":{
"$ref":"#/components/schemas/SiteDetailsLiteDto"
},
"sdfPropertyList":{
"type":"array",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFPropertyDetailsDto"
}
}
}
},
"SdfId":{
"type":"object",
"properties":{
"id":{
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"description":"Unique Id for SDF.",
"format":"uuid"
}
},
"description":"Contains SDF ID"
},
"AddLabSiteTO":{
"title":"AddLabSiteTO v1.0",
"required":[
"labs",
"sites"
],
"type":"object",
"properties":{
"sites":{
"title":"Sites",
"type":"array",
"description":"List of site identifiers to associate.",
"example":"B1B8327AFAA6412287106192AB5984EF",
"items":{
"type":"string"
}
},
"labs":{
"title":"Labs",
"type":"array",
"description":"List of lab identifiers to link to the sites.",
"example":"B1B8327AFAA6412287106192AB5984EF",
"items":{
"type":"string"
}
}
},
"description":"Request to link labs with sites."
},
"LabDto":{
"title":"LabDto v1.0",
"required":[
"name"
],
"type":"object",
"properties":{
"id":{
"title":"Lab ID",
"type":"string",
"description":"Unique identifier for the lab (UUID, uppercase hexadecimal).",
"format":"uuid"
},
"name":{
"title":"Lab Name",
"maxLength":200,
"minLength":0,
"type":"string",
"description":"Name of the lab.",
"example":"Central Lab"
},
"shortName":{
"title":"Lab Short Name",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Short name of the lab.",
"example":"CLAB"
},
"associatedSite":{
"title":"Associated Site",
"type":"string",
"description":"Identifier of the site to associate with the lab.",
"format":"uuid"
}
},
"description":"Payload used to create or update a lab."
},
"LabNormalTO":{
"title":"LabNormalTO v1.0",
"required":[
"ageFrom",
"ageFromUnits",
"ageTo",
"ageToUnits",
"effectiveDate",
"sequence",
"test"
],
"type":"object",
"properties":{
"labNormalId":{
"type":"string",
"format":"uuid"
},
"sequence":{
"title":"Sequence",
"minimum":1,
"type":"integer",
"description":"Ordering number for the lab normal.",
"format":"int32",
"example":5
},
"test":{
"title":"Test",
"type":"string",
"description":"Name of the lab test.",
"example":"HEMOGLOBIN"
},
"labUnit":{
"title":"Lab Unit",
"type":"string",
"description":"Measurement unit for the lab test.",
"example":"mg/dL"
},
"lowRange":{
"title":"Low Range",
"type":"string",
"description":"Lower limit for the lab normal range.",
"example":"10"
},
"highRange":{
"title":"High Range",
"type":"string",
"description":"Upper limit for the lab normal range.",
"example":"100"
},
"standardResult":{
"title":"Standard Result",
"type":"string",
"description":"Standard result value for the lab normal.",
"example":"100"
},
"gender":{
"title":"Gender",
"type":"string",
"description":"Gender applicable to the lab normal.",
"example":"Female"
},
"ageFrom":{
"title":"Age From",
"type":"integer",
"description":"Lower bound for the age range.",
"format":"int32",
"example":5
},
"ageTo":{
"title":"Age To",
"type":"integer",
"description":"Upper bound for the age range.",
"format":"int32",
"example":15
},
"ageFromUnits":{
"title":"Age From Units",
"type":"string",
"description":"Units used for the lower age bound.",
"example":"years"
},
"ageToUnits":{
"title":"Age To Units",
"type":"string",
"description":"Units used for the upper age bound.",
"example":"years"
},
"race":{
"title":"Race",
"type":"string",
"description":"Race targeted by the lab normal.",
"example":"Asian"
},
"fasting":{
"title":"Fasting",
"type":"string",
"description":"Fasting flag for the lab normal.",
"example":"Yes",
"enum":[
"Yes",
"No"
]
},
"effectiveDate":{
"title":"Effective Date",
"type":"string",
"description":"Date when the lab normal becomes effective.",
"format":"date",
"example":"2025-01-01"
}
},
"description":"Schema describing a lab normal entry."
},
"LabNormalBulkLookUpResponseV1":{
"title":"LabNormalBulkLookUpResponse v1.0",
"type":"object",
"properties":{
"labNormals":{
"title":"Lab Normals",
"type":"array",
"description":"Lookup responses returned by the bulk lookup.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/LookUpResponseV1"
}
}
},
"description":"Bulk lookup response for lab normals."
},
"LookUpResponseV1":{
"title":"LookUpResponse v1.0",
"type":"object",
"properties":{
"testName":{
"title":"Test Name",
"type":"string",
"description":"Test name returned by the lookup.",
"example":"HEMOGLOBIN"
},
"gender":{
"title":"Gender",
"type":"string",
"description":"Gender associated with the lookup result.",
"example":"Female"
},
"race":{
"title":"Race",
"type":"string",
"description":"Race associated with the lookup result.",
"example":"Asian"
},
"age":{
"title":"Age",
"type":"string",
"description":"Age associated with the lookup result.",
"example":"10"
},
"ageUnits":{
"title":"Age Units",
"type":"string",
"description":"Age units associated with the lookup result.",
"example":"years"
},
"collectionDate":{
"title":"Collection Date",
"type":"string",
"description":"Collection date associated with the lookup result.",
"format":"date",
"example":"2025-01-01"
},
"fasting":{
"title":"Fasting",
"type":"string",
"description":"Fasting info returned by the lookup.",
"example":"Yes"
},
"labNormalsData":{
"title":"Lab Normals",
"type":"array",
"description":"List of lab normals matching the lookup result.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/LabNormalTO"
}
}
},
"description":"One lab normal lookup result."
},
"LabNormalLookUpCriteriaV1":{
"title":"LabNormalLookUpCriteria v1.0",
"type":"object",
"properties":{
"testName":{
"title":"Test Name",
"type":"string",
"description":"Test name used as a lookup criterion.",
"example":"HEMOGLOBIN"
},
"gender":{
"title":"Gender",
"type":"string",
"description":"Gender used as a lookup criterion.",
"example":"Female"
},
"race":{
"title":"Race",
"type":"string",
"description":"Race used as a lookup criterion.",
"example":"Asian"
},
"age":{
"title":"Age",
"type":"string",
"description":"Age used as a lookup criterion.",
"example":"10"
},
"ageUnits":{
"title":"Age Units",
"type":"string",
"description":"Units for the lookup age.",
"example":"years"
},
"collectionDate":{
"title":"Collection Date",
"type":"string",
"description":"Collection date used as a lookup criterion.",
"format":"date",
"example":"2025-01-01"
},
"fasting":{
"title":"Fasting",
"type":"string",
"description":"Fasting flag used as a lookup criterion.",
"example":"Yes"
}
},
"description":"Criteria used to locate lab normals."
},
"LabNormalLookUpRequestV1":{
"title":"LabNormalLookUpRequest v1.0",
"type":"object",
"properties":{
"lookUpCriteria":{
"title":"Lookup Criteria",
"type":"array",
"description":"List of criteria used to look up lab normals.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/LabNormalLookUpCriteriaV1"
}
}
},
"description":"Payload that carries lab normal lookup criteria."
},
"LabHistoryResponseV1":{
"title":"LabHistoryResponse v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"name":{
"title":"Lab Name",
"type":"string",
"description":"Lab name recorded in this history entry.",
"example":"Central Lab"
},
"shortName":{
"title":"Lab Short Name",
"type":"string",
"description":"Short name captured in the history entry.",
"example":"CLAB"
},
"reason":{
"title":"Reason",
"type":"string",
"description":"Reason associated with the history record.",
"example":"Updated lab properties"
},
"comment":{
"title":"Comment",
"type":"string",
"description":"Comment attached to the history entry.",
"example":"Changed site assignments"
},
"operationType":{
"title":"Operation Type",
"type":"string",
"description":"Operation performed on the lab record (CREATE, UPDATE, or DELETE).",
"example":"UPDATE"
},
"userId":{
"type":"string",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this history version became active.",
"format":"date-time",
"example":"2025-01-01T08:30:00Z"
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when this history version was superseded.",
"format":"date-time",
"example":"2025-02-01T12:00:00Z"
}
},
"description":"History entry for lab changes."
},
"LabResponseV1":{
"title":"LabResponse v1.0",
"type":"object",
"properties":{
"labId":{
"type":"string",
"format":"uuid"
},
"name":{
"title":"Lab Name",
"type":"string",
"description":"Official name of the lab.",
"example":"Central Lab"
},
"shortName":{
"title":"Lab Short Name",
"type":"string",
"description":"Short name of the lab.",
"example":"CLAB"
}
},
"description":"Response containing lab summary information."
},
"SiteLabsAssociationResponseV2":{
"title":"SiteLabsAssociationResponse v2.0",
"required":[
"labs",
"sites"
],
"type":"object",
"properties":{
"sites":{
"title":"Sites",
"type":"array",
"description":"Study site identifiers returned in the response.",
"format":"uuid",
"example":"B1B8327AFAA6412287106192AB5984EF",
"items":{
"type":"string",
"format":"uuid"
}
},
"labs":{
"title":"Labs",
"type":"array",
"description":"Lab identifiers returned in the response.",
"format":"uuid",
"example":"B1B8327AFAA6412287106192AB5984EF",
"items":{
"type":"string",
"format":"uuid"
}
}
},
"description":"Response containing the site and lab identifiers after association."
},
"SiteLabsAssociationRequestV2":{
"title":"SiteLabsAssociationRequest v2.0",
"required":[
"labs",
"sites"
],
"type":"object",
"properties":{
"sites":{
"title":"Sites",
"type":"array",
"description":"Study site identifiers to associate.",
"format":"uuid",
"example":"B1B8327AFAA6412287106192AB5984EF",
"items":{
"type":"string",
"format":"uuid"
}
},
"labs":{
"title":"Labs",
"type":"array",
"description":"Lab identifiers to associate with the sites.",
"format":"uuid",
"example":"B1B8327AFAA6412287106192AB5984EF",
"items":{
"type":"string",
"format":"uuid"
}
}
},
"description":"Payload containing site and lab identifiers for association."
},
"LabCreateUpdateResponseV2":{
"title":"LabCreateUpdateResponse v2.0",
"type":"object",
"properties":{
"lab":{
"$ref":"#/components/schemas/lab"
},
"labAddresses":{
"title":"Lab Addresses",
"type":"array",
"description":"Address associations returned for the lab.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFAddressAssociationDto"
}
},
"labProperties":{
"title":"Lab Properties",
"type":"array",
"description":"Properties returned for the lab.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
}
},
"description":"Response containing the lab, addresses, and properties after persistence."
},
"lab":{
"title":"Lab",
"required":[
"labIdName",
"studySiteId",
"vendorId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"studyLabId":{
"type":"string",
"format":"uuid"
},
"vendorId":{
"type":"string",
"format":"uuid"
},
"studySiteId":{
"type":"string",
"format":"uuid"
},
"labIdName":{
"type":"string",
"example":"Central Lab"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
}
},
"description":"Lab details being created or updated.",
"example":{
"studyLabId":"B1B8327AFAA6412287106192AB5984EF",
"vendorId":"B1B8327AFAA6412287106192AB5984EF",
"studySiteId":"B1B8327AFAA6412287106192AB5984EF",
"labIdName":"Central Lab",
"versionStart":"2026-01-15T10:30:00Z"
}
},
"LabCreateUpdateRequestV2":{
"title":"LabCreateUpdateRequest v2.0",
"type":"object",
"properties":{
"lab":{
"$ref":"#/components/schemas/lab"
},
"labAddresses":{
"title":"Lab Addresses",
"type":"array",
"description":"Address associations for the lab.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFAddressAssociationDto"
}
},
"labProperties":{
"title":"Lab Properties",
"type":"array",
"description":"Properties associated with the lab.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"$ref":"#/components/schemas/SDFsPropertyDto"
}
}
},
"description":"Request payload containing lab details, addresses, and properties."
},
"LabSiteDto":{
"title":"LabSiteDto v1.0",
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Lab Site Association ID",
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"description":"Unique identifier for the lab-site association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when the association version began.",
"format":"date-time",
"example":"2025-01-01T00:00:00Z"
},
"labId":{
"title":"Lab ID",
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"description":"Identifier of the lab in the association.",
"format":"uuid"
},
"labVersionStart":{
"title":"Lab Version Start",
"type":"string",
"description":"Timestamp when the lab version started.",
"format":"date-time",
"example":"2025-01-01T00:00:00Z"
},
"siteId":{
"title":"Site ID",
"pattern":"^[A-F0-9]{32}$",
"type":"string",
"description":"Identifier of the site in the association.",
"format":"uuid"
},
"siteVersionStart":{
"title":"Site Version Start",
"type":"string",
"description":"Timestamp when the site version started.",
"format":"date-time",
"example":"2025-01-01T00:00:00Z"
}
},
"description":"Details of the lab-to-site association."
},
"LabDetailsDto":{
"required":[
"vendorId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"versionEnd":{
"title":"Version End",
"type":"string",
"description":"Timestamp when the version ended.",
"format":"date-time",
"example":"2026-03-30T12:00:00Z"
},
"operationType":{
"title":"Operation Type",
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Operation applied to the record. Allowed values: CREATED (record was added), MODIFIED (record was updated), REMOVED (record was logically removed).",
"example":"MODIFIED"
},
"userId":{
"title":"User ID",
"type":"string",
"description":"Identifier of the user who performed the audited action.",
"format":"uuid"
},
"objectVersionNumber":{
"title":"Object Version Number",
"type":"number",
"description":"Internal object version number captured for optimistic locking.",
"example":1
},
"softwareVersionNumber":{
"title":"Software Version Number",
"type":"number",
"description":"Software version number captured when the record was updated.",
"example":1
},
"studyLabId":{
"type":"string",
"format":"uuid"
},
"labId":{
"type":"string",
"format":"uuid"
},
"labName":{
"type":"string",
"example":"Sample Name"
},
"labStatus":{
"type":"string",
"format":"uuid"
},
"oldSdfId":{
"type":"string",
"format":"uuid"
},
"vendorId":{
"type":"string",
"format":"uuid"
},
"labIdName":{
"maxLength":50,
"minLength":0,
"type":"string",
"example":"Central Lab"
},
"versionStart":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
}
},
"example":{
"studyLabId":"B1B8327AFAA6412287106192AB5984EF",
"labId":"B1B8327AFAA6412287106192AB5984EF",
"labStatus":"ACTIVE"
}
},
"LabNormalOpTypeTO":{
"required":[
"labNormalList",
"operationType"
],
"type":"object",
"properties":{
"operationType":{
"type":"string",
"description":"Operation for each lab normal bundle. Allowed values: CREATE (add new lab normal rows), UPDATE (modify existing rows), REMOVE (delete existing rows).",
"example":"UPDATE",
"enum":[
"CREATE",
"UPDATE",
"REMOVE"
]
},
"labNormalList":{
"title":"Lab Normal List",
"type":"array",
"description":"Lab normals included in the operation.",
"example":[
{
"sequence":1,
"test":"HEMOGLOBIN",
"labUnit":"mg/dL",
"lowRange":"10",
"highRange":"100",
"gender":"Female",
"ageFrom":5,
"ageTo":15,
"ageFromUnits":"years",
"ageToUnits":"years"
}
],
"items":{
"$ref":"#/components/schemas/LabNormalTO"
}
}
}
},
"RegionCountryDto":{
"title":"RegionCountryDto v1.0",
"required":[
"countryId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
}
},
"description":"Country metadata captured for each region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"countryName":"United States"
}
]
},
"RegionDto":{
"title":"RegionDto v1.0",
"required":[
"name",
"regionCountries"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"name":{
"title":"Region Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official name of the region.",
"example":"North America Region"
},
"regionCountries":{
"title":"RegionCountryDto v1.0",
"required":[
"countryId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
}
},
"description":"Country metadata captured for each region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"countryName":"United States"
}
]
}
},
"description":"Region metadata that lists associated countries.",
"example":[
{
"id":"A0E1B2C3D4E5F67890123456789ABCDE",
"name":"North America Region"
}
]
},
"RegionCountriesResponse":{
"title":"RegionCountriesResponse v1.0",
"type":"object",
"properties":{
"regionCountries":{
"title":"RegionCountryDto v1.0",
"required":[
"countryId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
}
},
"description":"Country metadata captured for each region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"countryName":"United States"
}
]
}
},
"description":"Response containing countries associated with a region."
},
"RegionsResponse":{
"title":"RegionsResponse v1.0",
"type":"object",
"properties":{
"regions":{
"title":"RegionDto v1.0",
"required":[
"name",
"regionCountries"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"name":{
"title":"Region Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official name of the region.",
"example":"North America Region"
},
"regionCountries":{
"title":"RegionCountryDto v1.0",
"required":[
"countryId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
}
},
"description":"Country metadata captured for each region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"countryName":"United States"
}
]
}
},
"description":"Region metadata that lists associated countries.",
"example":[
{
"id":"A0E1B2C3D4E5F67890123456789ABCDE",
"name":"North America Region"
}
]
}
},
"description":"Response wrapping the region list returned by v1 APIs."
},
"RegionCountryStatesDto":{
"title":"RegionCountryStatesDto v2.0",
"required":[
"countryId",
"stateId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
},
"stateId":{
"title":"State ID",
"type":"string",
"description":"Identifier of the state associated with the country.",
"format":"uuid"
},
"stateName":{
"title":"State Name",
"type":"string",
"description":"Name of the state associated with the region.",
"example":"California"
}
},
"description":"Country and state metadata returned for a region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"stateId":"B0C1D2E3F4A567890123456789ABCDEF",
"stateName":"California"
}
]
},
"RegionStatesDto":{
"title":"RegionStatesDto v2.0",
"required":[
"name",
"regionCountriesStates"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"name":{
"title":"Region Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official name of the region.",
"example":"North America Region"
},
"regionCountriesStates":{
"title":"RegionCountryStatesDto v2.0",
"required":[
"countryId",
"stateId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
},
"stateId":{
"title":"State ID",
"type":"string",
"description":"Identifier of the state associated with the country.",
"format":"uuid"
},
"stateName":{
"title":"State Name",
"type":"string",
"description":"Name of the state associated with the region.",
"example":"California"
}
},
"description":"Country and state metadata returned for a region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"stateId":"B0C1D2E3F4A567890123456789ABCDEF",
"stateName":"California"
}
]
}
},
"description":"Region metadata that lists country and state associations."
},
"RegionCountriesResponse2":{
"title":"RegionCountriesResponse2 v2.0",
"type":"object",
"properties":{
"regionCountriesStates":{
"title":"RegionCountryStatesDto v2.0",
"required":[
"countryId",
"stateId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
},
"stateId":{
"title":"State ID",
"type":"string",
"description":"Identifier of the state associated with the country.",
"format":"uuid"
},
"stateName":{
"title":"State Name",
"type":"string",
"description":"Name of the state associated with the region.",
"example":"California"
}
},
"description":"Country and state metadata returned for a region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"stateId":"B0C1D2E3F4A567890123456789ABCDEF",
"stateName":"California"
}
]
}
},
"description":"Response containing countries and states associated with a region."
},
"RegionsResponse2":{
"title":"RegionsResponse v2.0",
"type":"object",
"properties":{
"regions":{
"title":"RegionStatesDto v2.0",
"required":[
"name",
"regionCountriesStates"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"name":{
"title":"Region Name",
"maxLength":100,
"minLength":1,
"type":"string",
"description":"Official name of the region.",
"example":"North America Region"
},
"regionCountriesStates":{
"title":"RegionCountryStatesDto v2.0",
"required":[
"countryId",
"stateId"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"Region Country ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the region-country association.",
"format":"uuid"
},
"versionStart":{
"title":"Version Start",
"type":"string",
"description":"Timestamp when this region-country association version was created.",
"format":"date-time",
"example":"2026-03-17T10:00:00Z"
},
"countryId":{
"title":"Country ID",
"type":"string",
"description":"Identifier of the country linked to the region.",
"format":"uuid"
},
"countryName":{
"title":"Country Name",
"type":"string",
"description":"Display name of the country associated with the region.",
"example":"United States"
},
"stateId":{
"title":"State ID",
"type":"string",
"description":"Identifier of the state associated with the country.",
"format":"uuid"
},
"stateName":{
"title":"State Name",
"type":"string",
"description":"Name of the state associated with the region.",
"example":"California"
}
},
"description":"Country and state metadata returned for a region.",
"example":[
{
"countryId":"A0E1B2C3D4E5F67890123456789ABCDE",
"stateId":"B0C1D2E3F4A567890123456789ABCDEF",
"stateName":"California"
}
]
}
},
"description":"Region metadata that lists country and state associations.",
"example":[
{
"id":"A0E1B2C3D4E5F67890123456789ABCDE",
"name":"North America Region",
"regionCountriesStates":[
{
"countryId":"C0D1E2F3A4B567890123456789ABCDEF",
"stateId":"B0C1D2E3F4A567890123456789ABCDEF",
"stateName":"California"
}
]
}
]
}
},
"description":"Response wrapping the region list returned by v2 APIs."
},
"SDFAddressDto":{
"title":"SDFAddressDto v1.0",
"required":[
"addressCity",
"addressCountry",
"addressPostalcode",
"addressStreet1",
"addressType"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Address ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the address.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF associated with the address.",
"format":"uuid"
},
"addressType":{
"title":"Address Type",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Label describing the address type such as Primary or Shipping.",
"example":"PRIMARY"
},
"addressStreet1":{
"title":"Address Street 1",
"maxLength":150,
"minLength":0,
"pattern":".*[A-z].*|.*\\p{L}+.*",
"type":"string",
"description":"Primary street address.",
"example":"123 Primary St"
},
"addressStreet2":{
"title":"Address Street 2",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Secondary street address (optional).",
"example":"Suite 500"
},
"addressCity":{
"title":"City",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"City for the address.",
"example":"Metropolis"
},
"addressStateOrProvOrCounty":{
"title":"State or Province or County",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"State, province, or county for the address.",
"example":"CA"
},
"addressPostalcode":{
"title":"Postal Code",
"maxLength":20,
"minLength":0,
"type":"string",
"description":"Postal or ZIP code for the address.",
"example":"94105"
},
"addressCountry":{
"title":"Country",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Country for the address.",
"example":"US"
},
"fax":{
"title":"Fax",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Fax number for the address contact.",
"example":"+1-555-321-0000"
},
"email":{
"title":"Email",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Email address for the site or depot.",
"format":"email",
"example":"site@clinicalone.com"
},
"phone":{
"title":"Phone",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Phone number for the address contact.",
"example":"+1-555-987-6543"
}
},
"description":"Address metadata returned for a site or depot.",
"example":[
{
"addressStreet1":"123 Primary St",
"addressCity":"Metropolis",
"addressCountry":"US"
}
]
},
"SDFModelDto":{
"title":"SDFModelDto v1.0",
"required":[
"sdf"
],
"type":"object",
"properties":{
"sdf":{
"$ref":"#/components/schemas/SDFDto"
},
"sdfPropertyList":{
"title":"SDFPropertyDto v1.0",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Property ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the property entry.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF the property belongs to.",
"format":"uuid"
},
"propertyName":{
"title":"Property Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Key identifying the property.",
"example":"PRIMARY_CONTACT"
},
"propertyValue":{
"title":"Property Value",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Value stored for the property.",
"example":"ACTIVE"
}
},
"description":"Property metadata attached to an SDF.",
"example":[
{
"propertyName":"PRIMARY",
"propertyValue":"ACTIVE"
}
]
},
"sdfAddresses":{
"title":"SDFAddressDto v1.0",
"required":[
"addressCity",
"addressCountry",
"addressPostalcode",
"addressStreet1",
"addressType"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Address ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the address.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF associated with the address.",
"format":"uuid"
},
"addressType":{
"title":"Address Type",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Label describing the address type such as Primary or Shipping.",
"example":"PRIMARY"
},
"addressStreet1":{
"title":"Address Street 1",
"maxLength":150,
"minLength":0,
"pattern":".*[A-z].*|.*\\p{L}+.*",
"type":"string",
"description":"Primary street address.",
"example":"123 Primary St"
},
"addressStreet2":{
"title":"Address Street 2",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Secondary street address (optional).",
"example":"Suite 500"
},
"addressCity":{
"title":"City",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"City for the address.",
"example":"Metropolis"
},
"addressStateOrProvOrCounty":{
"title":"State or Province or County",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"State, province, or county for the address.",
"example":"CA"
},
"addressPostalcode":{
"title":"Postal Code",
"maxLength":20,
"minLength":0,
"type":"string",
"description":"Postal or ZIP code for the address.",
"example":"94105"
},
"addressCountry":{
"title":"Country",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Country for the address.",
"example":"US"
},
"fax":{
"title":"Fax",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Fax number for the address contact.",
"example":"+1-555-321-0000"
},
"email":{
"title":"Email",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Email address for the site or depot.",
"format":"email",
"example":"site@clinicalone.com"
},
"phone":{
"title":"Phone",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Phone number for the address contact.",
"example":"+1-555-987-6543"
}
},
"description":"Address metadata returned for a site or depot.",
"example":[
{
"addressStreet1":"123 Primary St",
"addressCity":"Metropolis",
"addressCountry":"US"
}
]
}
},
"description":"Wrapper that returns an SDF plus its addresses and properties."
},
"SDFAddressRequest":{
"title":"SDFAddressRequest v1.0",
"required":[
"sdfAddress"
],
"type":"object",
"properties":{
"sdfAddress":{
"$ref":"#/components/schemas/SDFAddressDto"
}
},
"description":"Request payload that wraps an SDF address."
},
"SDFCreatePropertyRequest":{
"title":"SDFCreatePropertyRequest v1.0",
"type":"object",
"properties":{
"sdfPropertyList":{
"title":"SDFPropertyDto v1.0",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Property ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the property entry.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF the property belongs to.",
"format":"uuid"
},
"propertyName":{
"title":"Property Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Key identifying the property.",
"example":"PRIMARY_CONTACT"
},
"propertyValue":{
"title":"Property Value",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Value stored for the property.",
"example":"ACTIVE"
}
},
"description":"Property metadata attached to an SDF.",
"example":[
{
"propertyName":"PRIMARY_CONTACT",
"propertyValue":"ACTIVE"
}
]
}
},
"description":"Request payload that wraps multiple SDF properties."
},
"SDFWithCreationDate":{
"required":[
"sdf"
],
"type":"object",
"properties":{
"sdf":{
"$ref":"#/components/schemas/SDFDto"
},
"sdfPropertyList":{
"title":"SDFPropertyDto v1.0",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Property ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the property entry.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF the property belongs to.",
"format":"uuid"
},
"propertyName":{
"title":"Property Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Key identifying the property.",
"example":"PRIMARY_CONTACT"
},
"propertyValue":{
"title":"Property Value",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Value stored for the property.",
"example":"ACTIVE"
}
},
"description":"Property metadata attached to an SDF.",
"example":[
{
"propertyName":"PRIMARY",
"propertyValue":"ACTIVE"
}
]
},
"sdfAddresses":{
"title":"SDFAddressDto v1.0",
"required":[
"addressCity",
"addressCountry",
"addressPostalcode",
"addressStreet1",
"addressType"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Address ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the address.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF associated with the address.",
"format":"uuid"
},
"addressType":{
"title":"Address Type",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Label describing the address type such as Primary or Shipping.",
"example":"PRIMARY"
},
"addressStreet1":{
"title":"Address Street 1",
"maxLength":150,
"minLength":0,
"pattern":".*[A-z].*|.*\\p{L}+.*",
"type":"string",
"description":"Primary street address.",
"example":"123 Primary St"
},
"addressStreet2":{
"title":"Address Street 2",
"maxLength":150,
"minLength":0,
"type":"string",
"description":"Secondary street address (optional).",
"example":"Suite 500"
},
"addressCity":{
"title":"City",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"City for the address.",
"example":"Metropolis"
},
"addressStateOrProvOrCounty":{
"title":"State or Province or County",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"State, province, or county for the address.",
"example":"CA"
},
"addressPostalcode":{
"title":"Postal Code",
"maxLength":20,
"minLength":0,
"type":"string",
"description":"Postal or ZIP code for the address.",
"example":"94105"
},
"addressCountry":{
"title":"Country",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Country for the address.",
"example":"US"
},
"fax":{
"title":"Fax",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Fax number for the address contact.",
"example":"+1-555-321-0000"
},
"email":{
"title":"Email",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Email address for the site or depot.",
"format":"email",
"example":"site@clinicalone.com"
},
"phone":{
"title":"Phone",
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Phone number for the address contact.",
"example":"+1-555-987-6543"
}
},
"description":"Address metadata returned for a site or depot.",
"example":[
{
"addressStreet1":"123 Primary St",
"addressCity":"Metropolis",
"addressCountry":"US"
}
]
},
"creationDate":{
"type":"string",
"format":"date-time",
"example":"2026-01-15T10:30:00Z"
}
}
},
"MultipleSitePropertyUpdateRequestDto":{
"title":"MultipleSitePropertyUpdateRequestDto v1.0",
"type":"object",
"properties":{
"allSites":{
"title":"All Sites",
"type":"boolean",
"description":"Flag signifying whether the update applies to every site.",
"example":false
},
"siteIds":{
"title":"Site IDs",
"type":"array",
"description":"List of site identifiers targeted by the update.",
"example":[
"3F2504E0-4F89-11D3-9A0C-0305E82C3301"
],
"items":{
"title":"Site IDs",
"type":"string",
"description":"List of site identifiers targeted by the update.",
"format":"uuid"
}
},
"sdfPropertyList":{
"title":"SDFPropertyDto v1.0",
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"reason":{
"title":"Reason",
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the audited update.",
"example":"Protocol update requested by study operations."
},
"comment":{
"title":"Comment",
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment captured for the audited update.",
"example":"Association adjusted after data reconciliation."
},
"id":{
"title":"SDF Property ID",
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the property entry.",
"format":"uuid"
},
"versionStart":{
"type":"string",
"format":"date-time"
},
"sdfId":{
"title":"SDF ID",
"type":"string",
"description":"Identifier of the SDF the property belongs to.",
"format":"uuid"
},
"propertyName":{
"title":"Property Name",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Key identifying the property.",
"example":"PRIMARY_CONTACT"
},
"propertyValue":{
"title":"Property Value",
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Value stored for the property.",
"example":"ACTIVE"
}
},
"description":"Property metadata attached to an SDF.",
"example":[
{
"propertyName":"PRIMARY",
"propertyValue":"ACTIVE"
}
]
}
},
"description":"Payload used to apply property updates across multiple sites."
},
"SDFPropertyRequest":{
"title":"SDFPropertyRequest v1.0",
"required":[
"sdfProperty"
],
"type":"object",
"properties":{
"sdfProperty":{
"$ref":"#/components/schemas/SDFPropertyDto"
}
},
"description":"Request payload that wraps a single SDF property."
},
"StudyVersionRequest":{
"title":"StudyVersionRequest",
"required":[
"newVersion",
"oldVersion"
],
"type":"object",
"properties":{
"oldVersion":{
"title":"Old Version",
"maxLength":32,
"minLength":1,
"pattern":"^[0-9]+(\\.[0-9]+)*$",
"type":"string",
"description":"Existing study version identifier.",
"example":"1.0"
},
"newVersion":{
"title":"New Version",
"maxLength":32,
"minLength":1,
"pattern":"^[0-9]+(\\.[0-9]+)*$",
"type":"string",
"description":"Target study version identifier.",
"example":"2.0"
}
},
"description":"Request to update study version associations."
},
"KitsCreateResponseV10Doc":{
"title":"Kits Create Response v10.0",
"type":"object",
"properties":{
"status":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Envelope status returned by this endpoint. Allowed value: `success`, which indicates the Designer response wrapper was created successfully for this request.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"$ref":"#/components/schemas/KitsGetKitV10Doc"
},
"errorData":{
"$ref":"#/components/schemas/KitsGetErrorDoc"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by POST create kit."
},
"KitsGetAdvancedDosingCriteriaV10Doc":{
"title":"Kits GET Advanced Dosing Criterion v10.0",
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Criterion identifier.",
"format":"uuid"
},
"criteriaType":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Criterion type. `Question` evaluates a form response, `Dates` evaluates a date variable, `Cohort` matches cohort membership, `Treatment Arm` matches arm assignment, and `invalid` represents an unrecognized persisted value.",
"example":"Question",
"enum":[
"Question",
"Dates",
"Cohort",
"Treatment Arm",
"invalid"
]
},
"visitName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Visit name associated with the criterion.",
"example":"Screening"
},
"visitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Visit identifier associated with the criterion.",
"format":"uuid"
},
"formName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Form name associated with the criterion.",
"example":"Demographics"
},
"formId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Form identifier associated with the criterion.",
"format":"uuid"
},
"questionName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Question name associated with the criterion.",
"example":"Age"
},
"questionId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Question identifier associated with the criterion.",
"format":"uuid"
},
"variable":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Variable label associated with the criterion.",
"example":"System Screening Date"
},
"variableId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Variable identifier associated with the criterion.",
"format":"uuid"
},
"timePeriod":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Time period qualifier used by date-based criteria. `After` means the event occurs after the supplied date, `Before` means it occurs before the supplied date, and `invalid` represents an unrecognized persisted value.",
"example":"Before",
"enum":[
"After",
"Before",
"invalid"
]
},
"dateValue":{
"maxLength":10,
"minLength":10,
"type":"string",
"description":"Date value used by date-based criteria in `YYYY-MM-DD` format.",
"example":"2026-01-15"
},
"answer":{
"minItems":0,
"type":"array",
"description":"Selected answer values for choice-based criteria.",
"items":{
"$ref":"#/components/schemas/KitsGetLabelValueV10Doc"
}
},
"rule":{
"$ref":"#/components/schemas/KitsGetRuleV10Doc"
}
},
"description":"Advanced dosing group criterion."
},
"KitsGetAdvancedDosingGroupV10Doc":{
"title":"Kits GET Advanced Dosing Group v10.0",
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Advanced dosing group identifier.",
"format":"uuid"
},
"groupName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced dosing group name.",
"example":"Adults"
},
"groupCriteria":{
"minItems":0,
"type":"array",
"description":"Criteria that determine whether the group applies.",
"items":{
"$ref":"#/components/schemas/KitsGetAdvancedDosingCriteriaV10Doc"
}
},
"kitSettings":{
"minItems":0,
"type":"array",
"description":"Kit settings applied when the group criteria are satisfied.",
"items":{
"$ref":"#/components/schemas/KitsGetAdvancedDosingKitSettingsV10Doc"
}
},
"instructions":{
"maxLength":2000,
"minLength":1,
"type":"string",
"description":"Instructions shown for the advanced dosing group.",
"example":"Dispense one kit when the adult criteria are met."
}
},
"description":"Advanced dosing group definition."
},
"KitsGetAdvancedDosingKitSettingsV10Doc":{
"title":"Kits GET Advanced Dosing Kit Settings v10.0",
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Advanced dosing kit settings identifier.",
"format":"uuid"
},
"kitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Kit identifier.",
"format":"uuid"
},
"kitName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Kit name displayed in the advanced dosing group.",
"example":"Standard treatment kit"
},
"dosingId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dosing identifier referenced by this advanced dosing group.",
"format":"uuid"
},
"kitUnitSettings":{
"$ref":"#/components/schemas/KitsGetKitUnitSettingsV10Doc"
},
"dosings":{
"minItems":0,
"type":"array",
"description":"Calculated dosing definitions for the selected kit.",
"items":{
"$ref":"#/components/schemas/KitsGetKitDosingV10Doc"
}
},
"dosingLabel":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Dosing label displayed for the advanced dosing kit setting.",
"example":"Dose 1"
},
"quantity":{
"minimum":0,
"type":"integer",
"description":"Quantity of kits to dispense for this setting.",
"format":"int64",
"example":1
}
},
"description":"Kit settings used inside an advanced dosing group."
},
"KitsGetDoseSettingsV10Doc":{
"title":"Kits GET Dose Settings v10.0",
"type":"object",
"properties":{
"precision":{
"minimum":0,
"type":"integer",
"description":"Number of decimal places retained for the calculated dose.",
"format":"int32",
"example":1
},
"roundUp":{
"minimum":0,
"type":"integer",
"description":"Rounding direction flag for the calculated dose.",
"format":"int32",
"example":1
},
"frequency":{
"maxLength":128,
"minLength":1,
"type":"string",
"description":"Dosing frequency label.",
"example":"Daily"
},
"leftOverUnits":{
"type":"boolean",
"description":"Whether leftover units are carried into the next dose.",
"example":false
}
},
"description":"Dose calculation settings."
},
"KitsGetDosingMeasurementV10Doc":{
"title":"Kits GET Dosing Measurement v10.0",
"type":"object",
"properties":{
"kit":{
"$ref":"#/components/schemas/KitsGetValueUnitsV10Doc"
},
"subject":{
"$ref":"#/components/schemas/KitsGetValueUnitsV10Doc"
}
},
"description":"Kit and subject measurements used for dose calculation."
},
"KitsGetDosingQuestionV10Doc":{
"title":"Kits GET Dosing Question v10.0",
"type":"object",
"properties":{
"formId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Form identifier.",
"format":"uuid"
},
"itemId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Question identifier.",
"format":"uuid"
}
},
"description":"Form question reference used by a dosing definition."
},
"KitsGetDosingVisitV10Doc":{
"title":"Kits GET Dosing Visit v10.0",
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Visit identifier.",
"format":"uuid"
},
"type":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Visit type for the dosing source visit. Allowed values: ScreeningVisit, ScheduleAbleVisit, SubjectWithdrawalVisit, SubjectCompletionVisit, UnScheduleAbleVisit, Event, AdverseEvent, ScreenFailureVisit, ReScreeningEvent.",
"example":"ScreeningVisit",
"enum":[
"ScreeningVisit",
"ScheduleAbleVisit",
"SubjectWithdrawalVisit",
"SubjectCompletionVisit",
"UnScheduleAbleVisit",
"Event",
"AdverseEvent",
"ScreenFailureVisit",
"ReScreeningEvent"
]
}
},
"description":"Visit reference used by a dosing definition."
},
"KitsGetErrorDetailsDoc":{
"title":"Kits GET Error Details",
"type":"object",
"properties":{
"studyId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Study identifier from the request.",
"format":"uuid"
},
"version":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Study version from the request.",
"example":"1.0.0.1"
},
"kitType":{
"maxLength":21,
"minLength":3,
"type":"string",
"description":"Kit type filter from the request. Allowed values: `ALL` for every kit type, `STANDARD` for standard kits, `TITRATION` for titration kits, `DEVICE` for device kits, and `advancedDispensation` for advanced dispensation kits.",
"example":"ALL",
"enum":[
"ALL",
"STANDARD",
"TITRATION",
"DEVICE",
"advancedDispensation"
]
},
"kitTypeExclude":{
"type":"boolean",
"description":"Whether the request excluded the selected kit type instead of including it.",
"example":false
}
},
"description":"Request values echoed back in the error payload for troubleshooting.",
"example":{
"studyId":"CF1E6500073D4AD298F4DA93DA670786",
"version":"1.0.0.1",
"kitType":"ALL",
"kitTypeExclude":false
}
},
"KitsGetErrorDoc":{
"title":"Kits GET Error",
"type":"object",
"properties":{
"errorCode":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Application error code.",
"example":"C1-500"
},
"errorMessage":{
"maxLength":1024,
"minLength":1,
"type":"string",
"description":"Human-readable explanation of the failure.",
"example":"Unable to retrieve kits for the requested study version."
},
"details":{
"$ref":"#/components/schemas/KitsGetErrorDetailsDoc"
}
},
"description":"Error payload returned inside the Designer response envelope.",
"example":{
"errorCode":"C1-500",
"errorMessage":"Unable to retrieve kits for the requested study version.",
"details":{
"studyId":"CF1E6500073D4AD298F4DA93DA670786",
"version":"1.0.0.1",
"kitType":"ALL",
"kitTypeExclude":false
}
}
},
"KitsGetKitDosingV10Doc":{
"title":"Kits GET Kit Dosing v10.0",
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dosing identifier.",
"format":"uuid"
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Display name for the dosing definition.",
"example":"Weight-based dose"
},
"question":{
"$ref":"#/components/schemas/KitsGetDosingQuestionV10Doc"
},
"visit":{
"$ref":"#/components/schemas/KitsGetDosingVisitV10Doc"
},
"dose":{
"$ref":"#/components/schemas/KitsGetDoseSettingsV10Doc"
},
"measurement":{
"$ref":"#/components/schemas/KitsGetDosingMeasurementV10Doc"
}
},
"description":"Calculated dosing definition returned by GET kits."
},
"KitsGetKitSettingsV10Doc":{
"title":"Kits GET Kit Settings v10.0",
"type":"object",
"properties":{
"deviceType":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Device type for device kits. Allowed values: ActivityWatch, BloodPressureMonitor, WeightScale, ECGReader, Spirometer, MobileApp, SmartPillBottle, PulseOximeter, WearablePatch, Other, GlucoseMonitor.",
"example":"ActivityWatch",
"enum":[
"ActivityWatch",
"BloodPressureMonitor",
"WeightScale",
"ECGReader",
"Spirometer",
"MobileApp",
"SmartPillBottle",
"PulseOximeter",
"WearablePatch",
"Other",
"GlucoseMonitor"
]
},
"deviceConn":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Device connectivity type for device kits. `CloudtoCloud` means the device syncs through a third-party cloud service, `DevicetoCloud` means the device sends data directly to the platform cloud, and `NoConnection` means the device has no connectivity requirement.",
"example":"DevicetoCloud",
"enum":[
"CloudtoCloud",
"DevicetoCloud",
"NoConnection"
]
},
"calculatingDoses":{
"type":"boolean",
"description":"Whether the kit uses calculated dosing.",
"example":true
},
"titratingDoses":{
"type":"boolean",
"description":"Whether the kit supports titration dosing.",
"example":false
},
"titrationKit":{
"type":"boolean",
"description":"Whether the kit itself is a titration kit.",
"example":false
},
"distributionSetting":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Distribution setting for the kit. `BLINDED` hides treatment assignment, `UNBLINDED` exposes treatment assignment, and `UNBLINDEDPHARMAC` is unblinded for pharmacy-managed dispensing workflows.",
"example":"BLINDED",
"enum":[
"BLINDED",
"UNBLINDED",
"UNBLINDEDPHARMAC"
]
},
"kitTypeId":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Kit type identifier.",
"example":"KIT_STD_001"
},
"kitDescription":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Kit description displayed to users.",
"example":"Standard treatment kit"
},
"storageSetting":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Storage setting for the kit. `AMBIENT` means room-temperature storage, `FROZEN` means frozen storage, and `REFRIGERATED` means refrigerated storage.",
"example":"AMBIENT",
"enum":[
"AMBIENT",
"FROZEN",
"REFRIGERATED"
]
},
"trialSupplyType":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Trial supply type for the kit. Allowed values: BLISTERPACK, BOTTLE, DEVICE, SYRINGE, OINTMENT, VIAL, INHALER, INFUSION, BOX, OTHER.",
"example":"BOTTLE",
"enum":[
"BLISTERPACK",
"BOTTLE",
"DEVICE",
"SYRINGE",
"OINTMENT",
"VIAL",
"INHALER",
"INFUSION",
"BOX",
"OTHER"
]
},
"minShipUnits":{
"minimum":0,
"type":"integer",
"description":"Minimum number of ship units required for this kit.",
"format":"int64",
"example":10
},
"serialized":{
"type":"boolean",
"description":"Whether the kit is serialized.",
"example":true
},
"hazardousMaterial":{
"type":"boolean",
"description":"Whether the kit is hazardous material.",
"example":false
},
"controlSubstance":{
"type":"boolean",
"description":"Whether the kit is a controlled substance.",
"example":false
},
"bufferdays":{
"minimum":0,
"type":"integer",
"description":"Buffer days for dispensing calculations.",
"format":"int64",
"example":5
},
"dispenseOutsideWindow":{
"type":"boolean",
"description":"Whether the kit can be dispensed outside the visit window.",
"example":false
},
"dosingFrequency":{
"type":"boolean",
"description":"Whether titration dosing frequency is configured.",
"example":true
},
"doseChangeInUnschVisit":{
"type":"boolean",
"description":"Whether dose changes are allowed at unscheduled visits.",
"example":false
},
"maxDoseChanges":{
"minimum":0,
"type":"integer",
"description":"Maximum number of total dose changes.",
"format":"int64",
"example":3
},
"upTitrateDose":{
"minimum":0,
"type":"integer",
"description":"Maximum number of up-titration dose changes.",
"format":"int64",
"example":1
},
"downTitrateDose":{
"minimum":0,
"type":"integer",
"description":"Maximum number of down-titration dose changes.",
"format":"int64",
"example":2
},
"totalDoseUnscheduled":{
"minimum":0,
"type":"integer",
"description":"Maximum number of total dose changes allowed for unscheduled visits.",
"format":"int64",
"example":3
},
"upTitrateDoseUnscheduled":{
"minimum":0,
"type":"integer",
"description":"Maximum number of up-titration dose changes allowed for unscheduled visits.",
"format":"int64",
"example":1
},
"downTitrateDoseUnscheduled":{
"minimum":0,
"type":"integer",
"description":"Maximum number of down-titration dose changes allowed for unscheduled visits.",
"format":"int64",
"example":2
},
"timeBetweenUpDoseChangesUnit":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Unit used for the time between up-dose changes. `Days` measures the interval in calendar days and `Hours` measures the interval in hours.",
"example":"Days",
"enum":[
"Days",
"Hours"
]
},
"timeBetweenUpDoseChanges":{
"minimum":0,
"type":"integer",
"description":"Minimum time required between up-dose changes.",
"format":"int64",
"example":20
},
"timeBetweenUpDoseChangesException":{
"type":"boolean",
"description":"Whether an exception is allowed for the time between up-dose changes.",
"example":true
},
"timeBetweenDownDoseChangesUnit":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Unit used for the time between down-dose changes. `Days` measures the interval in calendar days and `Hours` measures the interval in hours.",
"example":"Days",
"enum":[
"Days",
"Hours"
]
},
"timeBetweenDownDoseChanges":{
"minimum":0,
"type":"integer",
"description":"Minimum time required between down-dose changes.",
"format":"int64",
"example":20
},
"timeBetweenDownDoseChangesException":{
"type":"boolean",
"description":"Whether an exception is allowed for the time between down-dose changes.",
"example":true
},
"dispenseOnHighestDose":{
"type":"boolean",
"description":"Whether to dispense on an up-titration request when the subject is already at the highest dose.",
"example":true
},
"dispenseOnLowestDose":{
"type":"boolean",
"description":"Whether to dispense on a down-titration request when the subject is already at the lowest dose.",
"example":true
},
"dispenseOnHighestDoseMsg":{
"maxLength":1024,
"minLength":1,
"type":"string",
"description":"Message shown when a subject is already at the highest dose.",
"example":"Subject is already at the highest dose."
},
"dispenseOnLowestDoseMsg":{
"maxLength":1024,
"minLength":1,
"type":"string",
"description":"Message shown when a subject is already at the lowest dose.",
"example":"Subject is already at the lowest dose."
}
},
"description":"Kit settings returned by GET kits."
},
"KitsGetKitUnitSettingsV10Doc":{
"title":"Kits GET Kit Unit Settings v10.0",
"type":"object",
"properties":{
"unitsPerKit":{
"minimum":0,
"type":"number",
"description":"Number of units per kit.",
"example":20
},
"singleUnitDose":{
"$ref":"#/components/schemas/KitsGetValueUnitsV10Doc"
}
},
"description":"Unit settings returned by GET kits."
},
"KitsGetKitV10Doc":{
"title":"Kits GET Kit v10.0",
"type":"object",
"properties":{
"kitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Kit identifier.",
"format":"uuid"
},
"kitSettings":{
"$ref":"#/components/schemas/KitsGetKitSettingsV10Doc"
},
"kitUnitSettings":{
"$ref":"#/components/schemas/KitsGetKitUnitSettingsV10Doc"
},
"kitTitrations":{
"minItems":0,
"type":"array",
"description":"Titration rows configured for the kit.",
"example":[
{
"rowId":"81B8327AFAA6412287106192AB5984EF",
"titrationKitId":"B1B8327AFAA6412287106192AB5984EF",
"titrationKitLabel":"Low Dose",
"titrationKitSeq":1,
"titrationKitJson":{
"titrationKitItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"upTitrationKitJson":{
"titrationKitItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"maintainTitrationKitJson":{
"titrationKitItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"downTitrationKitJson":{
"titrationKitItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
}
}
],
"items":{
"$ref":"#/components/schemas/KitsGetTitrationGroupV10Doc"
}
},
"dosings":{
"minItems":0,
"type":"array",
"description":"Calculated dosing definitions associated with the kit.",
"items":{
"$ref":"#/components/schemas/KitsGetKitDosingV10Doc"
}
},
"dosage":{
"minimum":0,
"type":"number",
"description":"Legacy dosage value returned for backward compatibility.",
"format":"double",
"example":50
},
"isDefault":{
"type":"boolean",
"description":"Whether this kit is the default kit for the current configuration.",
"example":true
},
"versionStart":{
"maxLength":40,
"minLength":20,
"type":"string",
"description":"Version start timestamp for the kit record.",
"format":"date-time",
"example":"2026-01-15T10:15:30Z"
},
"versionEnd":{
"maxLength":40,
"minLength":20,
"type":"string",
"description":"Version end timestamp for the kit record.",
"format":"date-time",
"example":"3099-12-31T00:00:00Z"
},
"studyId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Study identifier.",
"format":"uuid"
},
"studyVersionStart":{
"maxLength":40,
"minLength":20,
"type":"string",
"description":"Study version start timestamp.",
"format":"date-time",
"example":"2026-01-15T10:15:30Z"
},
"studyVersionEnd":{
"maxLength":40,
"minLength":20,
"type":"string",
"description":"Study version end timestamp.",
"format":"date-time",
"example":"3099-12-31T00:00:00Z"
},
"exceptions":{
"minItems":0,
"type":"array",
"description":"Titration exceptions configured for the kit.",
"items":{
"$ref":"#/components/schemas/KitsGetTitrationExceptionV10Doc"
}
},
"advancedDosing":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Advanced dosing flag for the kit. `0` means disabled and `1` means enabled.",
"format":"int32",
"example":1
},
"advancedDosingGroups":{
"minItems":0,
"type":"array",
"description":"Advanced dosing groups that define criteria-based kit selection rules.",
"items":{
"$ref":"#/components/schemas/KitsGetAdvancedDosingGroupV10Doc"
}
},
"libraryKitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Library kit identifier when the kit is based on a library kit.",
"format":"uuid"
},
"poolingId":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Pooling identifier for pooled kits.",
"example":"POOL12"
}
},
"description":"Kit details returned by the GET kits endpoint.",
"example":{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSettings":{
"deviceType":"ActivityWatch",
"deviceConn":"DevicetoCloud",
"calculatingDoses":true,
"titratingDoses":false,
"titrationKit":false,
"distributionSetting":"BLINDED",
"kitTypeId":"KIT_STD_001",
"kitDescription":"Standard treatment kit",
"storageSetting":"AMBIENT",
"trialSupplyType":"BOTTLE",
"minShipUnits":10,
"serialized":true,
"hazardousMaterial":false,
"controlSubstance":false,
"bufferdays":5,
"dispenseOutsideWindow":false
},
"kitUnitSettings":{
"unitsPerKit":20,
"singleUnitDose":{
"value":10,
"units":"mg"
}
},
"dosings":[
{
"id":"D1B8327AFAA6412287106192AB5984EF",
"name":"Weight-based dose",
"question":{
"formId":"E1B8327AFAA6412287106192AB5984EF",
"itemId":"F1B8327AFAA6412287106192AB5984EF"
},
"visit":{
"id":"A1B8327AFAA6412287106192AB5984EF",
"type":"ScreeningVisit"
},
"dose":{
"precision":1,
"roundUp":1,
"frequency":"Daily",
"leftOverUnits":false
},
"measurement":{
"kit":{
"value":10,
"units":"mg"
},
"subject":{
"value":70,
"units":"kg"
}
}
}
],
"exceptions":[
{
"id":"91B8327AFAA6412287106192AB5984EF",
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"sequence":1,
"startingDoseJson":{
"titrationKitExceptionItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"endingDoseJson":{
"titrationKitExceptionItems":[
{
"kitId":"C1B8327AFAA6412287106192AB5984EF",
"kitSeq":2,
"kitDosage":"BID",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"minTimeBetweenDoseChangesUnit":"Days",
"minTimeBetweenDoseChanges":2,
"exceptionType":"UP_EXCEPTION"
}
],
"advancedDosing":1,
"advancedDosingGroups":[
{
"id":"71B8327AFAA6412287106192AB5984EF",
"groupName":"Adults",
"groupCriteria":[
{
"id":"72B8327AFAA6412287106192AB5984EF",
"criteriaType":"Question",
"visitName":"Screening",
"visitId":"A1B8327AFAA6412287106192AB5984EF",
"formName":"Demographics",
"formId":"E1B8327AFAA6412287106192AB5984EF",
"questionName":"Age",
"questionId":"F1B8327AFAA6412287106192AB5984EF",
"variable":"System Screening Date",
"variableId":"73B8327AFAA6412287106192AB5984EF",
"timePeriod":"Before",
"dateValue":"2026-01-15",
"answer":[
{
"value":"18_PLUS",
"label":"18 years or older"
}
],
"rule":{
"id":"74B8327AFAA6412287106192AB5984EF",
"ruleName":"Greater Than Or Equal To",
"value":"18",
"valueList":[
{
"value":"18",
"label":"18"
}
],
"lower":{
"value":"18",
"inclusive":true
},
"upper":{
"value":"120",
"inclusive":true
}
}
}
],
"kitSettings":[
{
"id":"75B8327AFAA6412287106192AB5984EF",
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitName":"Standard treatment kit",
"dosingId":"D1B8327AFAA6412287106192AB5984EF",
"kitUnitSettings":{
"unitsPerKit":20,
"singleUnitDose":{
"value":10,
"units":"mg"
}
},
"dosings":[
{
"id":"D1B8327AFAA6412287106192AB5984EF",
"name":"Weight-based dose",
"question":{
"formId":"E1B8327AFAA6412287106192AB5984EF",
"itemId":"F1B8327AFAA6412287106192AB5984EF"
},
"visit":{
"id":"A1B8327AFAA6412287106192AB5984EF",
"type":"ScreeningVisit"
},
"dose":{
"precision":1,
"roundUp":1,
"frequency":"Daily",
"leftOverUnits":false
},
"measurement":{
"kit":{
"value":10,
"units":"mg"
},
"subject":{
"value":70,
"units":"kg"
}
}
}
],
"dosingLabel":"Dose 1",
"quantity":1
}
],
"instructions":"Dispense one kit when the adult criteria are met."
}
],
"versionStart":"2026-01-15T10:15:30Z",
"versionEnd":"3099-12-31T00:00:00Z",
"studyId":"CF1E6500073D4AD298F4DA93DA670786",
"studyVersionStart":"2026-01-15T10:15:30Z",
"studyVersionEnd":"3099-12-31T00:00:00Z",
"libraryKitId":"C1B8327AFAA6412287106192AB5984EF",
"poolingId":"POOL12",
"isDefault":true,
"dosage":50
}
},
"KitsGetLabelValueV10Doc":{
"title":"Kits GET Label Value v10.0",
"type":"object",
"properties":{
"value":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Stored value.",
"example":"18_PLUS"
},
"label":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Display label.",
"example":"18 years or older"
}
},
"description":"Label and value pair used across advanced dosing rules."
},
"KitsGetRangeRuleBoundaryV10Doc":{
"title":"Kits GET Range Rule Boundary v10.0",
"type":"object",
"properties":{
"value":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Boundary value.",
"example":"18"
},
"inclusive":{
"type":"boolean",
"description":"Whether the boundary is inclusive.",
"example":true
}
},
"description":"Boundary value for a range-based rule."
},
"KitsGetRuleV10Doc":{
"title":"Kits GET Rule v10.0",
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Rule identifier.",
"format":"uuid"
},
"ruleName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Rule display name.",
"example":"Greater Than Or Equal To"
},
"value":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Single rule value when the rule accepts one value.",
"example":"18"
},
"valueList":{
"minItems":0,
"type":"array",
"description":"List of allowed rule values for list-based rules.",
"items":{
"$ref":"#/components/schemas/KitsGetLabelValueV10Doc"
}
},
"lower":{
"$ref":"#/components/schemas/KitsGetRangeRuleBoundaryV10Doc"
},
"upper":{
"$ref":"#/components/schemas/KitsGetRangeRuleBoundaryV10Doc"
}
},
"description":"Advanced dosing evaluation rule."
},
"KitsGetTitrationExceptionItemsV10Doc":{
"title":"Kits GET Titration Exception Items v10.0",
"type":"object",
"properties":{
"titrationKitExceptionItems":{
"minItems":0,
"type":"array",
"description":"Titration kit items used by the exception.",
"example":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
],
"items":{
"$ref":"#/components/schemas/KitsGetTitrationKitItemV10Doc"
}
}
},
"description":"Collection of titration kit items used by an exception.",
"example":{
"titrationKitExceptionItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
}
},
"KitsGetTitrationExceptionV10Doc":{
"title":"Kits GET Titration Exception v10.0",
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Exception identifier.",
"format":"uuid"
},
"kitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Identifier of the kit that owns the exception.",
"format":"uuid"
},
"sequence":{
"minimum":0,
"type":"integer",
"description":"Display order for the exception.",
"format":"int64",
"example":1
},
"startingDoseJson":{
"$ref":"#/components/schemas/KitsGetTitrationExceptionItemsV10Doc"
},
"endingDoseJson":{
"$ref":"#/components/schemas/KitsGetTitrationExceptionItemsV10Doc"
},
"minTimeBetweenDoseChangesUnit":{
"maxLength":16,
"minLength":1,
"type":"string",
"description":"Minimum time-between-dose-changes unit for the exception. `Days` measures the interval in calendar days and `Hours` measures the interval in hours.",
"example":"Days",
"enum":[
"Days",
"Hours"
]
},
"minTimeBetweenDoseChanges":{
"minimum":0,
"type":"integer",
"description":"Minimum time between dose changes for the exception.",
"format":"int64",
"example":2
},
"exceptionType":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Exception type. `UP_EXCEPTION` applies when moving to a higher dose and `DOWN_EXCEPTION` applies when moving to a lower dose.",
"example":"UP_EXCEPTION",
"enum":[
"UP_EXCEPTION",
"DOWN_EXCEPTION"
]
}
},
"description":"Titration exception returned by GET kits."
},
"KitsGetTitrationGroupV10Doc":{
"title":"Kits GET Titration Group v10.0",
"type":"object",
"properties":{
"rowId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Titration row identifier.",
"format":"uuid"
},
"titrationKitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Current titration kit identifier.",
"format":"uuid"
},
"titrationKitLabel":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Dose level label for the titration row.",
"example":"Low Dose"
},
"titrationKitSeq":{
"minimum":0,
"type":"integer",
"description":"Sequence of the titration row inside the kit.",
"format":"int64",
"example":1
},
"titrationKitJson":{
"$ref":"#/components/schemas/KitsGetTitrationItemsV10Doc"
},
"upTitrationKitJson":{
"$ref":"#/components/schemas/KitsGetTitrationItemsV10Doc"
},
"maintainTitrationKitJson":{
"$ref":"#/components/schemas/KitsGetTitrationItemsV10Doc"
},
"downTitrationKitJson":{
"$ref":"#/components/schemas/KitsGetTitrationItemsV10Doc"
}
},
"description":"Titration group row returned by GET kits."
},
"KitsGetTitrationItemsV10Doc":{
"title":"Kits GET Titration Items v10.0",
"type":"object",
"properties":{
"titrationKitItems":{
"minItems":0,
"type":"array",
"description":"Titration kit items in the current group.",
"example":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
],
"items":{
"$ref":"#/components/schemas/KitsGetTitrationKitItemV10Doc"
}
}
},
"description":"Collection of titration kit items.",
"example":{
"titrationKitItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
}
},
"KitsGetTitrationKitItemV10Doc":{
"title":"Kits GET Titration Kit Item v10.0",
"type":"object",
"properties":{
"kitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Kit identifier.",
"format":"uuid"
},
"kitSeq":{
"minimum":0,
"type":"integer",
"description":"Sequence of the kit inside the titration list.",
"format":"int64",
"example":1
},
"kitDosage":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Dosage label for the kit.",
"example":"QD"
},
"dosageId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dosage identifier for the kit.",
"format":"uuid"
}
},
"description":"Titration kit item returned by GET kits."
},
"KitsGetValueUnitsV10Doc":{
"title":"Kits GET Value Units v10.0",
"type":"object",
"properties":{
"value":{
"minimum":0,
"type":"number",
"description":"Numeric value for the measurement.",
"format":"double",
"example":10
},
"units":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Measurement units.",
"example":"mg"
}
},
"description":"Value and unit pair used by dosing and kit unit settings."
},
"AdvancedDosingGroupCriteriaDtoV1":{
"title":"Advanced Dosing Group Criteria v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Group Criteria GUID",
"format":"uuid"
},
"Criteria type value":{
"type":"string",
"description":"Criteria type value",
"example":"Variable",
"enum":[
"Question",
"Dates",
"Cohort",
"Treatment Arm",
"invalid"
]
},
"Visit name":{
"type":"string",
"description":"Visit name",
"example":"Screening"
},
"visitId":{
"type":"string",
"description":"Visit GUID",
"format":"uuid"
},
"Form name":{
"type":"string",
"description":"Form name",
"example":"Demographics"
},
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"Question name":{
"type":"string",
"description":"Question name",
"example":"Gender"
},
"questionId":{
"type":"string",
"description":"Question GUID",
"format":"uuid"
},
"Variable type value":{
"type":"string",
"description":"Variable type value",
"example":"System Screening Date"
},
"variableId":{
"type":"string",
"description":"Variable codelist GUID",
"format":"uuid"
},
"timePeriod":{
"type":"string",
"description":"Timeframe for variable",
"example":"Before"
},
"Date Value":{
"type":"string",
"description":"Date Value for variable",
"example":"2023-03-15"
},
"Answer":{
"type":"array",
"description":"Answer for choice question name",
"example":"Female",
"items":{
"$ref":"#/components/schemas/GenericAttributeDtoV1"
}
},
"rule":{
"$ref":"#/components/schemas/AdvancedDosingRuleDtoV1"
}
},
"description":"Advanced Dosing Group Criteria details"
},
"AdvancedDosingGroupDtoV1":{
"title":"Advanced Dosing Group v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Advanced dosing group GUID",
"format":"uuid"
},
"Group name":{
"type":"string",
"description":"Group name",
"example":"Group A"
},
"Group criteria":{
"type":"array",
"description":"Group criteria",
"items":{
"$ref":"#/components/schemas/AdvancedDosingGroupCriteriaDtoV1"
}
},
"Kit settings":{
"type":"array",
"description":"Kit settings",
"items":{
"$ref":"#/components/schemas/AdvancedDosingKitSettingsDtoV1"
}
},
"Instructions":{
"type":"string",
"description":"Instructions",
"example":"Group amndatory details should be provided"
}
},
"description":"Advanced Dosing Group details"
},
"AdvancedDosingKitSettingsDtoV1":{
"title":"Advanced Dosing Kit Settings v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Kits settings GUID",
"format":"uuid"
},
"kitid":{
"type":"string",
"description":"Kit GUID",
"format":"uuid"
},
"Kit name":{
"type":"string",
"description":"Kit name",
"example":"Kit a"
},
"dosingId":{
"type":"string",
"description":"Dosing GUID",
"format":"uuid"
},
"kitUnitSettings":{
"$ref":"#/components/schemas/KitUnitSettingsDtoV10"
},
"dosings":{
"type":"array",
"description":"Calculated dosing definitions for the kit",
"items":{
"$ref":"#/components/schemas/KitDosingDtoV10"
}
},
"Dosing Label":{
"type":"string",
"description":"Dosing Label",
"example":"Dose3"
},
"quantity":{
"type":"integer",
"description":"Kit quantity or dose.",
"format":"int64",
"example":1
}
},
"description":"Advanced Dosing Kit Settings details"
},
"AdvancedDosingRuleDtoV1":{
"title":"Advanced Dosing Rule v1.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Rule Unique GUID",
"format":"uuid"
},
"ruleName":{
"type":"string",
"description":"Rule name",
"example":"Greater Than Or Equal To"
},
"Rule value":{
"type":"string",
"description":"Rule value",
"example":"2"
},
"Rule value list":{
"type":"string",
"description":"Rule value list"
},
"lower":{
"$ref":"#/components/schemas/RangeRuleValues"
},
"upper":{
"$ref":"#/components/schemas/RangeRuleValues"
}
},
"description":"Advanced Dosing rule details"
},
"GenericAttributeDtoV1":{
"title":"Generic Attribute v1.0",
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Attribute value. For example, Cohort1 UUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"type":"string",
"description":"Attribute label",
"example":"Cohort1"
}
},
"description":"Generic attribute name, value and label details",
"example":"Female"
},
"KitDosingDoseDtoV10":{
"title":"KitDosingDoseDto v10.0",
"type":"object",
"properties":{
"precision":{
"type":"integer",
"format":"int32"
},
"roundUp":{
"type":"integer",
"description":"Rounded up for dosing calculation",
"format":"int32",
"example":1
},
"frequency":{
"type":"string",
"description":"Dosing frequency",
"example":"Before bedtime"
},
"leftOverUnits":{
"type":"boolean",
"description":"Use leftover units in next dose",
"example":true
}
},
"description":"Dose information on the calculated dose."
},
"KitDosingDtoV10":{
"title":"KitDosingDto v10.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Dosing GUID",
"format":"uuid"
},
"name":{
"type":"string",
"description":"Dosing display name",
"example":"Name"
},
"question":{
"$ref":"#/components/schemas/KitDosingQuestionDtoV10"
},
"visit":{
"$ref":"#/components/schemas/KitDosingVisitDtoV10"
},
"dose":{
"$ref":"#/components/schemas/KitDosingDoseDtoV10"
},
"measurement":{
"$ref":"#/components/schemas/KitDosingMeasurementDtoV10"
}
},
"description":"Information on a calculated dose."
},
"KitDosingMeasurementDtoV10":{
"title":"KitDosingMeasurementDto v10.0",
"type":"object",
"properties":{
"kit":{
"$ref":"#/components/schemas/KitDosingValueUnitsDtoV10"
},
"subject":{
"$ref":"#/components/schemas/KitDosingValueUnitsDtoV10"
}
},
"description":"Kit and subject measurement information on a calculated dose."
},
"KitDosingQuestionDtoV10":{
"title":"KitDosingQuestionDto v10.0",
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"The form Id",
"format":"uuid"
},
"itemId":{
"type":"string",
"description":"The question Id",
"format":"uuid"
}
},
"description":"Form and question information on the calculated dose."
},
"KitDosingValueUnitsDtoV10":{
"title":"KitDosingValueUnitsDto v10.0",
"type":"object",
"properties":{
"value":{
"type":"number",
"description":"The value of a measurement",
"format":"double",
"example":50
},
"units":{
"type":"string",
"description":"The unit of a measurement",
"example":"mg"
}
},
"description":"Describes the value/unit pair of the measurement on the calculated dose."
},
"KitDosingVisitDtoV10":{
"title":"KitDosingVisitDto v10.0",
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"The visit Id",
"format":"uuid"
},
"type":{
"type":"string",
"description":"The type of visit, eg. screening, scheduled, or current",
"example":"screening"
}
},
"description":"Visit information on the calculated dose."
},
"KitSettingsDtoV10":{
"title":"KitSettingsDto v10.0",
"type":"object",
"properties":{
"deviceType":{
"type":"string",
"description":"Indicates type of device in case of device kit",
"example":"Blood pressure monitor"
},
"deviceConn":{
"type":"string",
"description":"Indicates device connection in case of device kit",
"example":"Cloud to Cloud"
},
"calculatingDoses":{
"type":"boolean",
"description":"Indicates if the kit has calculating doses",
"example":true
},
"titratingDoses":{
"type":"boolean",
"description":"Indicates if the kit has titrating doses",
"example":true
},
"titrationKit":{
"type":"boolean",
"description":"Indicates if the kit is a titration kit",
"example":true
},
"distributionSetting":{
"type":"string",
"description":"Indicates if the kit blinded or unblinded",
"example":"BLINDED"
},
"kitTypeId":{
"type":"string",
"description":"The kit type id",
"example":"Type"
},
"kitDescription":{
"type":"string",
"description":"The kit description",
"example":"ORS-123(IP 0.01%)"
},
"storageSetting":{
"type":"string",
"description":"The storage temperature",
"example":"AMBIENT"
},
"trialSupplyType":{
"type":"string",
"description":"The kit type",
"example":"BOTTLE"
},
"minShipUnits":{
"type":"integer",
"description":"The minimum kit to ship",
"format":"int64",
"example":10
},
"serialized":{
"type":"boolean",
"description":"Is kit serialized?",
"example":true
},
"hazardousMaterial":{
"type":"boolean",
"description":"Is kit hazardous?",
"example":false
},
"controlSubstance":{
"type":"boolean",
"description":"Is kit a control substance?",
"example":false
},
"bufferdays":{
"type":"integer",
"description":"The number of buffer days",
"format":"int64",
"example":5
},
"dispenseOutsideWindow":{
"type":"boolean",
"description":"Indicates if the kit may be dispensed outside the window",
"example":false
},
"dosingFrequency":{
"type":"boolean",
"description":"Indicates if the titration kit has dosing frequencies defined",
"example":true
},
"doseChangeUnschVisit":{
"type":"boolean",
"description":"Indicates if dosage change is allowed in an unscheduled visit for the titration kit",
"example":false
},
"maxDoseChanges":{
"type":"integer",
"description":"The maximum number of dosage changes allowed for the titration kit",
"format":"int64",
"example":3
},
"upTitrateDose":{
"type":"integer",
"description":"The maximum number of up titrate dosage change allowed for the titration kit",
"format":"int64",
"example":1
},
"downTitrateDose":{
"type":"integer",
"description":"The maximum number of down titrate dosage change allowed for the titration kit",
"format":"int64",
"example":2
},
"totalDoseUnscheduled":{
"type":"integer",
"description":"The maximum number of dosage changes allowed for the titration kit for unscheduled visits",
"format":"int64",
"example":3
},
"upTitrateDoseUnscheduled":{
"type":"integer",
"description":"The maximum number of up titrate dosage change allowed for the titration kit for unscheduled visits",
"format":"int64",
"example":1
},
"downTitrateDoseUnscheduled":{
"type":"integer",
"description":"The maximum number of down titrate dosage change allowed for the titration kit for unscheduled visits",
"format":"int64",
"example":2
},
"timeBetweenUpDoseChangesUnit":{
"type":"string",
"description":"Unit for time between up dosage changes",
"example":"DAYS"
},
"timeBetweenUpDoseChanges":{
"type":"integer",
"description":"Time between up dosage changes",
"format":"int64",
"example":20
},
"timeBetweenUpDoseChangesException":{
"type":"boolean",
"description":"Time between up dosage changes exception",
"format":"true",
"example":true
},
"timeBetweenDownDoseChangesUnit":{
"type":"string",
"description":"Unit for time between down dosage changes",
"example":"DAYS"
},
"timeBetweenDownDoseChanges":{
"type":"integer",
"description":"Time between down dosage changes",
"format":"int64",
"example":20
},
"timeBetweenDownDoseChangesException":{
"type":"boolean",
"description":"Time between down dosage changes exception",
"format":"true",
"example":true
},
"dispenseOnHighestDose":{
"type":"boolean",
"description":"Indicates if dispensation should happen on up titrate when already on highest dose",
"example":true
},
"dispenseOnLowestDose":{
"type":"boolean",
"description":"Indicates if dispensation should happen on down titrate when already on lowest dose",
"example":true
},
"dispenseOnHighestDoseMsg":{
"type":"string",
"description":"Message to user on up titrate when subject is on highest dose",
"example":"Message when subject is on highest dose"
},
"dispenseOnLowestDoseMsg":{
"type":"string",
"description":"Message to user on down titrate when subject is on lowest dose",
"example":"Message when subject is on lowest dose"
}
},
"description":"Contains settings information on the kit."
},
"KitTitrationsDtoV10":{
"title":"KitTitrationsDto v10.0",
"type":"object",
"properties":{
"rowId":{
"type":"string",
"description":"Id of the titration row",
"format":"uuid"
},
"titrationKitId":{
"type":"string",
"description":"Id of the current titration kit",
"format":"uuid"
},
"titrationKitLabel":{
"type":"string",
"description":"Custom optional Dose Level title to indicate a dose level for a row within a Titration Group",
"example":"Low Dose"
},
"titrationKitSeq":{
"type":"integer",
"description":"Sequence number of the current titration row within the kit",
"format":"int64",
"example":5
},
"titrationKitJson":{
"$ref":"#/components/schemas/TitrationKitItemsDtoV10"
},
"upTitrationKitJson":{
"$ref":"#/components/schemas/TitrationKitItemsDtoV10"
},
"maintainTitrationKitJson":{
"$ref":"#/components/schemas/TitrationKitItemsDtoV10"
},
"downTitrationKitJson":{
"$ref":"#/components/schemas/TitrationKitItemsDtoV10"
}
},
"description":"Contains titrations information on the titration kit."
},
"KitUnitSettingsDtoV10":{
"title":"KitUnitSettingsDto v10.0",
"type":"object",
"properties":{
"unitsPerKit":{
"type":"number",
"description":"The number of units per kit",
"format":"double",
"example":20
},
"singleUnitDose":{
"$ref":"#/components/schemas/KitDosingValueUnitsDtoV10"
}
},
"description":"Contains unit settings information on the kit."
},
"RangeRuleValues":{
"type":"object",
"properties":{
"value":{
"type":"string",
"description":"Boundary value for range",
"example":"1"
},
"inclusive":{
"type":"boolean",
"description":"Flag that indicates whether boundary condition value is inclusive while consideration",
"example":true
}
},
"description":"Range rule upper boundary details"
},
"RqstKitDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"format":"uuid"
},
"kitid":{
"type":"string",
"description":"Kit GUID",
"format":"uuid"
},
"kitSettings":{
"$ref":"#/components/schemas/KitSettingsDtoV10"
},
"kitUnitSettings":{
"$ref":"#/components/schemas/KitUnitSettingsDtoV10"
},
"kitTitrations":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTitrationsDtoV10"
}
},
"dosings":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitDosingDtoV10"
}
},
"dosage":{
"type":"number",
"description":"Dosage.",
"format":"double",
"example":50
},
"isDefault":{
"type":"boolean",
"description":"Is kit default.",
"example":true
},
"versionStart":{
"type":"string",
"description":"Version Start",
"format":"date-time"
},
"versionEnd":{
"type":"string",
"description":"Version End",
"format":"date-time"
},
"studyId":{
"type":"string",
"description":"Study GUID",
"format":"uuid"
},
"studyVersionStart":{
"type":"string",
"description":"Study version start",
"format":"date-time"
},
"studyVersionEnd":{
"type":"string",
"description":"Study version end",
"format":"date-time"
},
"exceptions":{
"type":"array",
"items":{
"$ref":"#/components/schemas/KitTitrationsDtoV10"
}
},
"advancedDosing":{
"type":"integer",
"format":"int32"
},
"advancedDosingGroups":{
"type":"array",
"items":{
"$ref":"#/components/schemas/AdvancedDosingGroupDtoV1"
}
},
"libraryKitId":{
"type":"string",
"description":"Library Kit GUID",
"format":"uuid"
},
"poolingId":{
"type":"string",
"description":"Pooling Kit ID",
"example":"POL12"
}
}
},
"TitrationKitItemDtoV10":{
"title":"TitrationKitItemDto v10.0",
"type":"object",
"properties":{
"kitid":{
"type":"string",
"description":"Kit GUID",
"format":"uuid"
},
"kitSeq":{
"type":"integer",
"description":"Kit Sequence",
"format":"int64",
"example":1
},
"kitDosage":{
"type":"string",
"description":"Kit Dosage",
"example":"QD"
},
"dosageId":{
"type":"string",
"description":"Dosage Id",
"example":"B1B8327AFAA6412287106192AB5984EF"
}
},
"description":"Titration Kit Item"
},
"TitrationKitItemsDtoV10":{
"title":"TitrationKitItemsDto v10.0",
"type":"object",
"properties":{
"titrationKitItems":{
"type":"array",
"items":{
"$ref":"#/components/schemas/TitrationKitItemDtoV10"
}
}
},
"description":"Titration Kit Items"
},
"KitsDeleteResponseV10Doc":{
"title":"Kits Delete Response v10.0",
"type":"object",
"properties":{
"status":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Envelope status returned by this endpoint. Allowed value: `success`, which indicates the Designer response wrapper was created successfully for this request.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Deletion status message returned by the service.",
"example":"Kit deleted successfully."
},
"errorData":{
"$ref":"#/components/schemas/KitsGetErrorDoc"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by DELETE kit."
},
"KitsGetByIdResponseV10Doc":{
"title":"Kits GET By Id Response v10.0",
"type":"object",
"properties":{
"status":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Envelope status returned by this endpoint. Allowed value: `success`, which indicates the Designer response wrapper was created successfully for this request.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"$ref":"#/components/schemas/KitsGetKitV10Doc"
},
"errorData":{
"$ref":"#/components/schemas/KitsGetErrorDoc"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by GET kit by id."
},
"KitsGetResponseV10Doc":{
"title":"Kits GET Response v10.0",
"type":"object",
"properties":{
"status":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Envelope status returned by this endpoint. Allowed value: `success`, which indicates the Designer response wrapper was created successfully for this request.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"minItems":0,
"type":"array",
"description":"List of kits returned for the requested study version.",
"example":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF"
}
],
"items":{
"$ref":"#/components/schemas/KitsGetKitV10Doc"
}
},
"errorData":{
"$ref":"#/components/schemas/KitsGetErrorDoc"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by GET kits."
},
"KitsUpdateResponseV10Doc":{
"title":"Kits Update Response v10.0",
"type":"object",
"properties":{
"status":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Envelope status returned by this endpoint. Allowed value: `success`, which indicates the Designer response wrapper was created successfully for this request.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"$ref":"#/components/schemas/KitsGetKitV10Doc"
},
"errorData":{
"$ref":"#/components/schemas/KitsGetErrorDoc"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by PUT update kit."
},
"VisitArmKitVisitBlindedInfoV10Doc":{
"title":"Visit Arm Kit Visit Blinded Info v10.0",
"type":"object",
"properties":{
"kitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Kit identifier.",
"format":"uuid"
},
"armid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Treatment arm identifier.",
"format":"uuid"
},
"visitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Visit identifier.",
"format":"uuid"
},
"adGroupId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Advanced dispensation group identifier when advanced dosing selected this row.",
"format":"uuid"
},
"dosingId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dosing identifier associated with the row.",
"format":"uuid"
},
"quantity":{
"minimum":0,
"type":"integer",
"description":"Quantity of kits or dose to dispense for the visit row.",
"format":"int64",
"example":1
},
"dnd":{
"minimum":0,
"type":"integer",
"description":"Do-not-dispense threshold in days before kit expiration.",
"format":"int64",
"example":5
},
"dispenseoutsidewindow":{
"type":"boolean",
"description":"Whether the kit can be dispensed outside the visit window.",
"example":false
},
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dispensation row identifier.",
"format":"uuid"
},
"allowTitration":{
"type":"boolean",
"description":"Whether titration is allowed for the row.",
"example":true
},
"titrationKits":{
"minItems":0,
"type":"array",
"description":"Titration kits associated with the row.",
"items":{
"$ref":"#/components/schemas/VisitArmKitVisitTitrationV10Doc"
}
},
"blindedInfo":{
"$ref":"#/components/schemas/KitsGetKitV10Doc"
}
},
"description":"Visit kit dispensation row with blinded kit information."
},
"VisitArmKitVisitTitrationV10Doc":{
"title":"Visit Arm Kit Visit Titration v10.0",
"type":"object",
"properties":{
"kitTypeId":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Kit type label for the titration kit.",
"example":"KIT_STD_001"
},
"kitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Titration kit identifier.",
"format":"uuid"
},
"kitQuantity":{
"minimum":0,
"type":"integer",
"description":"Quantity of kits dispensed for this titration entry.",
"format":"int64",
"example":1
}
},
"description":"Titration kit summary associated with a visit row."
},
"VisitKitsBlindedInfoResponseV10Doc":{
"title":"Visit Kits Blinded Info Response v10.0",
"type":"object",
"properties":{
"status":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Envelope status returned by this endpoint. Allowed value: `success`, which indicates the Designer response wrapper was created successfully for this request.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"minItems":0,
"type":"array",
"description":"Visit kit rows with blinded kit information for the requested visit.",
"example":[
{
"kitid":"B1B8327AFAA6412287106192AB5984EF",
"armid":"C1B8327AFAA6412287106192AB5984EF",
"visitid":"A1B8327AFAA6412287106192AB5984EF",
"adGroupId":"71B8327AFAA6412287106192AB5984EF",
"dosingId":"D1B8327AFAA6412287106192AB5984EF",
"quantity":1,
"dnd":5,
"dispenseoutsidewindow":false,
"id":"E1B8327AFAA6412287106192AB5984EF",
"allowTitration":true,
"titrationKits":[
{
"kitTypeId":"KIT_STD_001",
"kitid":"B1B8327AFAA6412287106192AB5984EF",
"kitQuantity":1
}
],
"blindedInfo":{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSettings":{
"deviceType":"ActivityWatch",
"deviceConn":"DevicetoCloud",
"calculatingDoses":true,
"titratingDoses":false,
"titrationKit":false,
"distributionSetting":"BLINDED",
"kitTypeId":"KIT_STD_001",
"kitDescription":"Standard treatment kit",
"storageSetting":"AMBIENT",
"trialSupplyType":"BOTTLE",
"minShipUnits":10,
"serialized":true,
"hazardousMaterial":false,
"controlSubstance":false,
"bufferdays":5,
"dispenseOutsideWindow":false
},
"kitUnitSettings":{
"unitsPerKit":20,
"singleUnitDose":{
"value":10,
"units":"mg"
}
},
"dosings":[
{
"id":"D1B8327AFAA6412287106192AB5984EF",
"name":"Weight-based dose",
"question":{
"formId":"E1B8327AFAA6412287106192AB5984EF",
"itemId":"F1B8327AFAA6412287106192AB5984EF"
},
"visit":{
"id":"A1B8327AFAA6412287106192AB5984EF",
"type":"ScreeningVisit"
},
"dose":{
"precision":1,
"roundUp":1,
"frequency":"Daily",
"leftOverUnits":false
},
"measurement":{
"kit":{
"value":10,
"units":"mg"
},
"subject":{
"value":70,
"units":"kg"
}
}
}
],
"exceptions":[
{
"id":"91B8327AFAA6412287106192AB5984EF",
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"sequence":1,
"startingDoseJson":{
"titrationKitExceptionItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"endingDoseJson":{
"titrationKitExceptionItems":[
{
"kitId":"C1B8327AFAA6412287106192AB5984EF",
"kitSeq":2,
"kitDosage":"BID",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"minTimeBetweenDoseChangesUnit":"Days",
"minTimeBetweenDoseChanges":2,
"exceptionType":"UP_EXCEPTION"
}
],
"advancedDosing":1,
"advancedDosingGroups":[
{
"id":"71B8327AFAA6412287106192AB5984EF",
"groupName":"Adults",
"groupCriteria":[
{
"id":"72B8327AFAA6412287106192AB5984EF",
"criteriaType":"Question",
"visitName":"Screening",
"visitId":"A1B8327AFAA6412287106192AB5984EF",
"formName":"Demographics",
"formId":"E1B8327AFAA6412287106192AB5984EF",
"questionName":"Age",
"questionId":"F1B8327AFAA6412287106192AB5984EF",
"variable":"System Screening Date",
"variableId":"73B8327AFAA6412287106192AB5984EF",
"timePeriod":"Before",
"dateValue":"2026-01-15",
"answer":[
{
"value":"18_PLUS",
"label":"18 years or older"
}
],
"rule":{
"id":"74B8327AFAA6412287106192AB5984EF",
"ruleName":"Greater Than Or Equal To",
"value":"18",
"valueList":[
{
"value":"18",
"label":"18"
}
],
"lower":{
"value":"18",
"inclusive":true
},
"upper":{
"value":"120",
"inclusive":true
}
}
}
],
"kitSettings":[
{
"id":"75B8327AFAA6412287106192AB5984EF",
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitName":"Standard treatment kit",
"dosingId":"D1B8327AFAA6412287106192AB5984EF",
"kitUnitSettings":{
"unitsPerKit":20,
"singleUnitDose":{
"value":10,
"units":"mg"
}
},
"dosings":[
{
"id":"D1B8327AFAA6412287106192AB5984EF",
"name":"Weight-based dose",
"question":{
"formId":"E1B8327AFAA6412287106192AB5984EF",
"itemId":"F1B8327AFAA6412287106192AB5984EF"
},
"visit":{
"id":"A1B8327AFAA6412287106192AB5984EF",
"type":"ScreeningVisit"
},
"dose":{
"precision":1,
"roundUp":1,
"frequency":"Daily",
"leftOverUnits":false
},
"measurement":{
"kit":{
"value":10,
"units":"mg"
},
"subject":{
"value":70,
"units":"kg"
}
}
}
],
"dosingLabel":"Dose 1",
"quantity":1
}
],
"instructions":"Dispense one kit when the adult criteria are met."
}
],
"versionStart":"2026-01-15T10:15:30Z",
"versionEnd":"3099-12-31T00:00:00Z",
"studyId":"CF1E6500073D4AD298F4DA93DA670786",
"studyVersionStart":"2026-01-15T10:15:30Z",
"studyVersionEnd":"3099-12-31T00:00:00Z",
"libraryKitId":"C1B8327AFAA6412287106192AB5984EF",
"poolingId":"POOL12",
"isDefault":true,
"dosage":50
}
}
],
"items":{
"$ref":"#/components/schemas/VisitArmKitVisitBlindedInfoV10Doc"
}
},
"errorData":{
"$ref":"#/components/schemas/KitsGetErrorDoc"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by GET visit kits blinded info."
},
"VisitDispensingsResponseV10Doc":{
"title":"Visit Dispensings Response v10.0",
"type":"object",
"properties":{
"status":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Envelope status returned by this endpoint. Allowed value: `success`, which indicates the Designer response wrapper was created successfully for this request.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"minItems":0,
"type":"array",
"description":"Visit dispensation rows for the requested visit.",
"example":[
{
"kitid":"B1B8327AFAA6412287106192AB5984EF",
"armid":"C1B8327AFAA6412287106192AB5984EF",
"visitid":"A1B8327AFAA6412287106192AB5984EF",
"adGroupId":"71B8327AFAA6412287106192AB5984EF",
"dosingId":"D1B8327AFAA6412287106192AB5984EF",
"quantity":1,
"dnd":5,
"dispenseoutsidewindow":false,
"id":"E1B8327AFAA6412287106192AB5984EF",
"allowTitration":true,
"titrationKits":[
{
"kitTypeId":"KIT_STD_001",
"kitid":"B1B8327AFAA6412287106192AB5984EF",
"kitQuantity":1
}
],
"blindedInfo":{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSettings":{
"deviceType":"ActivityWatch",
"deviceConn":"DevicetoCloud",
"calculatingDoses":true,
"titratingDoses":false,
"titrationKit":false,
"distributionSetting":"BLINDED",
"kitTypeId":"KIT_STD_001",
"kitDescription":"Standard treatment kit",
"storageSetting":"AMBIENT",
"trialSupplyType":"BOTTLE",
"minShipUnits":10,
"serialized":true,
"hazardousMaterial":false,
"controlSubstance":false,
"bufferdays":5,
"dispenseOutsideWindow":false
},
"kitUnitSettings":{
"unitsPerKit":20,
"singleUnitDose":{
"value":10,
"units":"mg"
}
},
"dosings":[
{
"id":"D1B8327AFAA6412287106192AB5984EF",
"name":"Weight-based dose",
"question":{
"formId":"E1B8327AFAA6412287106192AB5984EF",
"itemId":"F1B8327AFAA6412287106192AB5984EF"
},
"visit":{
"id":"A1B8327AFAA6412287106192AB5984EF",
"type":"ScreeningVisit"
},
"dose":{
"precision":1,
"roundUp":1,
"frequency":"Daily",
"leftOverUnits":false
},
"measurement":{
"kit":{
"value":10,
"units":"mg"
},
"subject":{
"value":70,
"units":"kg"
}
}
}
],
"exceptions":[
{
"id":"91B8327AFAA6412287106192AB5984EF",
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"sequence":1,
"startingDoseJson":{
"titrationKitExceptionItems":[
{
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitSeq":1,
"kitDosage":"QD",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"endingDoseJson":{
"titrationKitExceptionItems":[
{
"kitId":"C1B8327AFAA6412287106192AB5984EF",
"kitSeq":2,
"kitDosage":"BID",
"dosageId":"D1B8327AFAA6412287106192AB5984EF"
}
]
},
"minTimeBetweenDoseChangesUnit":"Days",
"minTimeBetweenDoseChanges":2,
"exceptionType":"UP_EXCEPTION"
}
],
"advancedDosing":1,
"advancedDosingGroups":[
{
"id":"71B8327AFAA6412287106192AB5984EF",
"groupName":"Adults",
"groupCriteria":[
{
"id":"72B8327AFAA6412287106192AB5984EF",
"criteriaType":"Question",
"visitName":"Screening",
"visitId":"A1B8327AFAA6412287106192AB5984EF",
"formName":"Demographics",
"formId":"E1B8327AFAA6412287106192AB5984EF",
"questionName":"Age",
"questionId":"F1B8327AFAA6412287106192AB5984EF",
"variable":"System Screening Date",
"variableId":"73B8327AFAA6412287106192AB5984EF",
"timePeriod":"Before",
"dateValue":"2026-01-15",
"answer":[
{
"value":"18_PLUS",
"label":"18 years or older"
}
],
"rule":{
"id":"74B8327AFAA6412287106192AB5984EF",
"ruleName":"Greater Than Or Equal To",
"value":"18",
"valueList":[
{
"value":"18",
"label":"18"
}
],
"lower":{
"value":"18",
"inclusive":true
},
"upper":{
"value":"120",
"inclusive":true
}
}
}
],
"kitSettings":[
{
"id":"75B8327AFAA6412287106192AB5984EF",
"kitId":"B1B8327AFAA6412287106192AB5984EF",
"kitName":"Standard treatment kit",
"dosingId":"D1B8327AFAA6412287106192AB5984EF",
"kitUnitSettings":{
"unitsPerKit":20,
"singleUnitDose":{
"value":10,
"units":"mg"
}
},
"dosings":[
{
"id":"D1B8327AFAA6412287106192AB5984EF",
"name":"Weight-based dose",
"question":{
"formId":"E1B8327AFAA6412287106192AB5984EF",
"itemId":"F1B8327AFAA6412287106192AB5984EF"
},
"visit":{
"id":"A1B8327AFAA6412287106192AB5984EF",
"type":"ScreeningVisit"
},
"dose":{
"precision":1,
"roundUp":1,
"frequency":"Daily",
"leftOverUnits":false
},
"measurement":{
"kit":{
"value":10,
"units":"mg"
},
"subject":{
"value":70,
"units":"kg"
}
}
}
],
"dosingLabel":"Dose 1",
"quantity":1
}
],
"instructions":"Dispense one kit when the adult criteria are met."
}
],
"versionStart":"2026-01-15T10:15:30Z",
"versionEnd":"3099-12-31T00:00:00Z",
"studyId":"CF1E6500073D4AD298F4DA93DA670786",
"studyVersionStart":"2026-01-15T10:15:30Z",
"studyVersionEnd":"3099-12-31T00:00:00Z",
"libraryKitId":"C1B8327AFAA6412287106192AB5984EF",
"poolingId":"POOL12",
"isDefault":true,
"dosage":50
}
}
],
"items":{
"$ref":"#/components/schemas/VisitArmKitVisitBlindedInfoV10Doc"
}
},
"errorData":{
"$ref":"#/components/schemas/KitsGetErrorDoc"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by GET visit dispensings."
},
"FormsRandomizationFactorAdvancedPropRuleV13":{
"type":"object",
"properties":{
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property rule name.",
"example":"RolloverQuestionAnswer"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property rule value.",
"example":"91A0C3E0D0B5445A95BA3AB2D84D6755"
},
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Advanced property rule label shown in the UI.",
"example":"Yes"
}
},
"description":"Advanced property rule details for a randomization factor form item."
},
"FormsRandomizationFactorAdvancedPropV13":{
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Advanced property unique identifier.",
"format":"uuid"
},
"type":{
"maxLength":30,
"minLength":1,
"type":"string",
"description":"Advanced property type. Allowed values: RolloverQuestion = rollover-study question mapping, CodeQuestion = coded-question mapping, ShowQuestion = conditional show rule for a question, ShowForm = conditional show rule for a form, ShowVisit = conditional show rule for a visit, ShowSection = conditional show rule for a section, StatusRule = status-driven rule, DataClassification = data classification mapping, VISITBRANCH = assigned visit-branch mapping, LinkForm = linked form action, AssignedVisits = assigned visit mapping, TriggerSafetyCase = safety case trigger mapping, EHRMapping = EHR field mapping, E2BR3Mapping = E2B(R3) field mapping.",
"example":"RolloverQuestion",
"enum":[
"RolloverQuestion",
"CodeQuestion",
"ShowQuestion",
"ShowForm",
"ShowVisit",
"ShowSection",
"StatusRule",
"DataClassification",
"VISITBRANCH",
"LinkForm",
"AssignedVisits",
"TriggerSafetyCase",
"EHRMapping",
"E2BR3Mapping"
]
},
"name":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Advanced property name.",
"example":"RolloverQuestionStudyId"
},
"value":{
"maxLength":2048,
"minLength":1,
"type":"string",
"description":"Advanced property value.",
"example":"B1B8327AFAA6412287106192AB5984EF"
},
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Advanced property label shown in the UI.",
"example":"Rollover Study BT-31"
},
"rules":{
"type":"array",
"description":"Rules attached to the advanced property.",
"example":[
{
"name":"RolloverQuestionAnswer",
"value":"91A0C3E0D0B5445A95BA3AB2D84D6755",
"label":"Yes"
}
],
"items":{
"$ref":"#/components/schemas/FormsRandomizationFactorAdvancedPropRuleV13"
}
},
"parentObjectId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Parent object identifier when the property is inherited from a parent object.",
"format":"uuid"
},
"parentObjectLevel":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Parent object hierarchy level when present.",
"example":"FORM"
},
"parentObjectLabel":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Parent object label when present.",
"example":"Demography"
}
},
"description":"Advanced property mapping details for a randomization factor form item."
},
"FormsRandomizationFactorItemV13":{
"type":"object",
"properties":{
"questionType":{
"maxLength":17,
"minLength":4,
"type":"string",
"description":"Question type. Allowed values: text = free-text question, instructionalText = read-only instructional content, numeric = numeric question, datetime = date or date-time question, choice = coded selection question, questionGroup = grouped child questions, table = tabular child question group, label = non-editable label-style choice item, section = section container for grouped questions, existingData = value sourced from existing study data, fileUpload = file attachment question.",
"example":"numeric",
"enum":[
"text",
"instructionalText",
"numeric",
"datetime",
"choice",
"questionGroup",
"table",
"label",
"section",
"existingData",
"fileUpload"
]
},
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Form item unique identifier.",
"format":"uuid"
},
"formId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Parent form unique identifier.",
"format":"uuid"
},
"visitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Assigned visit unique identifier when the item is scoped to a single visit.",
"format":"uuid"
},
"visitIds":{
"type":"array",
"description":"Assigned visit identifiers when the item is scoped to multiple visits.",
"example":[
"E1D7C7D4D8444D60A5304F0E0A9967D1"
],
"items":{
"type":"string",
"description":"Assigned visit identifiers when the item is scoped to multiple visits.",
"example":"[\"E1D7C7D4D8444D60A5304F0E0A9967D1\"]"
}
},
"formTitle":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Parent form title.",
"example":"Demography"
},
"questionLabel":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Question label displayed to study designers.",
"example":"Age"
},
"questionHint":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Question hint shown in the UI when configured.",
"example":"Enter the subject age in years."
},
"randomizationTag":{
"type":"boolean",
"description":"Indicates whether the item is tagged for randomization.",
"example":true
},
"isStrataFactor":{
"type":"boolean",
"description":"Indicates whether the item is tagged as a strata factor.",
"example":true
},
"isCohortFactor":{
"type":"boolean",
"description":"Indicates whether the item is tagged as a cohort factor.",
"example":false
},
"refname":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Stable form item reference name.",
"example":"AGE_01"
},
"applyChangeToVersion":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Study version that should also receive the item change when apply-to-version is used.",
"example":"1.0.0.1"
},
"required":{
"type":"boolean",
"description":"Indicates whether a response is required for the item.",
"example":true
},
"dynamic":{
"minimum":0,
"type":"integer",
"description":"Number of leading questions that must be satisfied before this item is shown. Negative values are not allowed.",
"format":"int32",
"example":0
},
"hidden":{
"type":"boolean",
"description":"Indicates whether the item is hidden.",
"example":false
},
"readOnly":{
"type":"boolean",
"description":"Indicates whether the item is read-only.",
"example":false
},
"ruleSet":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"JSON-formatted rule set used to validate answers.",
"example":"{\"logicalOperator\":\"NONE\",\"rules\":[],\"numberIndex\":1}"
},
"sdvRequired":{
"maxLength":8,
"minLength":6,
"type":"string",
"description":"Source Data Verification requirement. Allowed values: NOTSET = no explicit SDV setting is configured, NEVER = SDV is not required, ALWAYS = SDV is always required, CRITICAL = SDV is required only for critical data.",
"example":"NEVER",
"enum":[
"NOTSET",
"NEVER",
"ALWAYS",
"CRITICAL"
]
},
"sequence":{
"minimum":0,
"type":"integer",
"description":"Item display order within the form. Negative values are not allowed.",
"format":"int32",
"example":1
},
"groupSequence":{
"minimum":0,
"type":"integer",
"description":"Group display order for grouped items. Negative values are not allowed.",
"format":"int32",
"example":0
},
"smartItemId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Linked smart item unique identifier.",
"format":"uuid"
},
"formula":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Smart item formula definition.",
"example":"[{\"ruleName\":\"AGE\",\"ruleExpression\":\"AgeInYears(AGE_DOB_01, visitDate)\"}]"
},
"smartObject":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Smart object identifier used by the formula.",
"example":"AGE"
},
"advancedProps":{
"type":"array",
"description":"Advanced property mappings configured for the form item.",
"example":[
{
"id":"2E2D8A4E3F5C4C2F96A43B9F0BEF5142",
"type":"RolloverQuestion",
"name":"RolloverQuestionStudyId",
"value":"B1B8327AFAA6412287106192AB5984EF",
"label":"Rollover Study BT-31",
"rules":[
{
"name":"RolloverQuestionAnswer",
"value":"91A0C3E0D0B5445A95BA3AB2D84D6755",
"label":"Yes"
}
],
"parentObjectId":"7F6C4D52A1D04CF9A75D06B2F454A172",
"parentObjectLevel":"FORM",
"parentObjectLabel":"Demography"
}
],
"items":{
"$ref":"#/components/schemas/FormsRandomizationFactorAdvancedPropV13"
}
},
"sasVariable":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"SAS variable name used for downstream extracts.",
"example":"AGE"
},
"sasLabel":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"SAS label used for downstream extracts.",
"example":"Subject Age"
},
"labNormalsTag":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Lab normals tag assigned to the item.",
"example":"LabTest"
},
"clLabNormalsTag":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Lab normals tag assigned through the linked code list.",
"example":"LabGender"
},
"dataClassificationIds":{
"type":"array",
"description":"Data classification mappings associated with the item.",
"example":[
{
"id":"F5BBE9E730234785A64C593C3EE4F8AA",
"type":"DataClassification",
"name":"ClassificationId",
"value":"SUBJECT",
"label":"Subject Data",
"rules":[
{
"name":"Access",
"value":"EDIT",
"label":"Edit"
}
],
"parentObjectId":"7F6C4D52A1D04CF9A75D06B2F454A172",
"parentObjectLevel":"FORM",
"parentObjectLabel":"Demography"
}
],
"items":{
"$ref":"#/components/schemas/FormsRandomizationFactorAdvancedPropV13"
}
},
"dataClassificationLevel":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Assigned data classification level when present.",
"example":"edit"
},
"e2br3Mapping":{
"type":"array",
"description":"E2B(R3) mappings associated with the item.",
"example":[
{
"id":"5FDFAB0EEAE34950B0DEBFC2DD0B8D20",
"type":"E2BR3Mapping",
"name":"E2BR3Field",
"value":"patient.agegroup",
"label":"Patient Age Group",
"rules":[
{
"name":"Profile",
"value":"DEFAULT",
"label":"Default"
}
],
"parentObjectId":"7F6C4D52A1D04CF9A75D06B2F454A172",
"parentObjectLevel":"FORM",
"parentObjectLabel":"Demography"
}
],
"items":{
"$ref":"#/components/schemas/FormsRandomizationFactorAdvancedPropV13"
}
},
"requiredScreening":{
"type":"boolean",
"description":"Indicates whether the item is required for screening.",
"example":false
},
"requiredRandomization":{
"type":"boolean",
"description":"Indicates whether the item is required for randomization.",
"example":true
},
"requiredDispensation":{
"type":"boolean",
"description":"Indicates whether the item is required for dispensation.",
"example":false
},
"requiredForCaseCreate":{
"type":"boolean",
"description":"Indicates whether the item is required for safety case creation.",
"example":false
},
"triggerFollowupCase":{
"type":"boolean",
"description":"Indicates whether the item can trigger a follow-up case.",
"example":false
},
"formCategory":{
"maxLength":3,
"minLength":3,
"type":"string",
"description":"Form category for the item.",
"example":"DCS"
},
"formSubcategory":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Form subcategory for the item when present.",
"example":"Baseline"
},
"display":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Choice display mode.",
"example":"selectbox"
},
"columnLayout":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Choice column layout identifier.",
"example":"EBCF17C5F8D4460AA4A9673485C79CF0"
},
"columnLayoutLabel":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Choice column layout label.",
"example":"Single"
},
"options":{
"type":"array",
"description":"Choice options available for choice and label items.",
"example":[
{
"label":"Yes",
"value":"1",
"clCode":"Y",
"clDescription":"Yes",
"clValue":"Yes",
"clItemId":"91A0C3E0D0B5445A95BA3AB2D84D6755",
"hidden":false,
"optionSeq":"1"
}
],
"items":{
"$ref":"#/components/schemas/FormsRandomizationFactorOptionV13"
}
},
"clTitle":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Linked code list title for choice items.",
"example":"Gender"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Linked code list description for choice items.",
"example":"Standard gender codelist"
},
"isCodeListReplaced":{
"type":"boolean",
"description":"Indicates whether the linked code list has been replaced.",
"example":false
},
"items":{
"type":"array",
"description":"Child items contained in a question group, table, or section item.",
"example":[
{
"questionType":"text",
"id":"D4F7297E3E2C4D8A91C09938F31A7AC1",
"questionLabel":"Weight comment",
"refname":"WEIGHT_COMMENT",
"required":false,
"sdvRequired":"NOTSET",
"maxlength":4000,
"multiline":true
}
],
"items":{
"$ref":"#/components/schemas/FormsRandomizationFactorItemV13"
}
},
"allowAdditionalRows":{
"type":"boolean",
"description":"Indicates whether additional rows can be added to a table item.",
"example":false
},
"precision":{
"minimum":0,
"type":"integer",
"description":"Numeric precision for numeric items. Negative values are not allowed.",
"format":"int32",
"example":0
},
"units":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Measurement units for numeric items.",
"example":"years"
},
"format":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Date or date-time format.",
"example":"yyyy-MM-dd"
},
"allowPartialDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Indicates whether partial dates are allowed. Allowed values are 0 and 1.",
"format":"int32",
"example":1
},
"partialDate":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Partial date format used when partial dates are allowed.",
"example":"MMM-yyyy"
},
"allowFutureDate":{
"maximum":1,
"minimum":0,
"type":"integer",
"description":"Indicates whether future dates are allowed. Allowed values are 0 and 1.",
"format":"int32",
"example":1
},
"maxlength":{
"maximum":4000,
"minimum":0,
"type":"integer",
"description":"Maximum text length for text items. Negative values are not allowed.",
"format":"int32",
"example":4000
},
"multiline":{
"type":"boolean",
"description":"Indicates whether the text item supports multiple lines.",
"example":false
},
"existingDataCodeName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Existing-data code list name.",
"example":"EDLSite"
},
"existingDataCodeValue":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Existing-data code list value.",
"example":"SiteName"
}
},
"description":"Randomization factor form item details returned by the v13 forms randomization factors endpoint."
},
"FormsRandomizationFactorOptionV13":{
"type":"object",
"properties":{
"label":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Choice option label.",
"example":"Yes"
},
"value":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Choice option stored value.",
"example":"1"
},
"clCode":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Linked code list code.",
"example":"Y"
},
"clDescription":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Linked code list description.",
"example":"Yes"
},
"clValue":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Linked code list display value.",
"example":"Yes"
},
"formCategory":{
"maxLength":3,
"minLength":3,
"type":"string",
"description":"Form category for the option when present.",
"example":"DCS"
},
"formSubcategory":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Form subcategory for the option when present.",
"example":"Baseline"
},
"instructionalText":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Instructional text associated with the option.",
"example":"Choose the option that applies."
},
"clItemId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Choice option code list item unique identifier.",
"format":"uuid"
},
"hidden":{
"type":"boolean",
"description":"Indicates whether the option is hidden.",
"example":false
},
"optionSeq":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Choice option sequence value.",
"example":"1"
}
},
"description":"Choice option details for a randomization factor form item."
},
"RandomizationDetailsV3Doc":{
"type":"object",
"properties":{
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Randomization design title.",
"example":"Rand 001"
},
"description":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Randomization design description.",
"example":"Method to assign study participants to a treatment group."
},
"algorithm":{
"maxLength":31,
"minLength":4,
"type":"string",
"description":"Randomization algorithm. Allowed values: None = no randomization algorithm configured, Central = centrally managed randomization without stratification, CentralStratified = central stratified randomization, SiteBlockedFixed = site-blocked fixed randomization, SiteBlockedFixedStratified = site-blocked fixed stratified randomization, SiteBlockedDynamic = site-blocked dynamic randomization, SiteBlockedDynamicStratified = site-blocked dynamic stratified randomization, CountryBlockedFixed = country-blocked fixed randomization, CountryBlockedFixedStratified = country-blocked fixed stratified randomization, CountryBlockedDynamic = country-blocked dynamic randomization, CountryBlockedDynamicStratified = country-blocked dynamic stratified randomization, RegionBlockedFixed = region-blocked fixed randomization, RegionBlockedFixedStratified = region-blocked fixed stratified randomization, RegionBlockedDynamic = region-blocked dynamic randomization, RegionBlockedDynamicStratified = region-blocked dynamic stratified randomization, Minimization = minimization algorithm.",
"example":"Central",
"enum":[
"None",
"Central",
"CentralStratified",
"SiteBlockedFixed",
"SiteBlockedFixedStratified",
"SiteBlockedDynamic",
"SiteBlockedDynamicStratified",
"CountryBlockedFixed",
"CountryBlockedFixedStratified",
"CountryBlockedDynamic",
"CountryBlockedDynamicStratified",
"RegionBlockedFixed",
"RegionBlockedFixedStratified",
"RegionBlockedDynamic",
"RegionBlockedDynamicStratified",
"Minimization"
]
},
"cohortType":{
"maxLength":10,
"minLength":7,
"type":"string",
"description":"Cohort behavior for the randomization design. Allowed values: NoCohort = no cohorting is applied, Adaptive = adaptive cohorts are used, Demography = demographic cohorts are used, invalid = unrecognized persisted value.",
"example":"NoCohort",
"enum":[
"NoCohort",
"Adaptive",
"Demography",
"invalid"
]
},
"randomizationType":{
"maxLength":10,
"minLength":7,
"type":"string",
"description":"Randomization blinding type. Allowed values: Blinded = subject assignments remain blinded, Unblinded = subject assignments are visible, invalid = unrecognized persisted value.",
"example":"Blinded",
"enum":[
"Blinded",
"Unblinded",
"invalid"
]
},
"reRandomization":{
"type":"boolean",
"description":"Indicates whether re-randomization is enabled.",
"example":true
},
"treatmentArms":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Treatment arm assignment mode. Allowed values: Randomized = arms are assigned by the randomization algorithm, Mapped = arms are mapped explicitly, None = no treatment arms are configured, invalid = unrecognized persisted value.",
"example":"Randomized",
"enum":[
"Randomized",
"Mapped",
"None",
"invalid"
]
}
},
"description":"Randomization design details returned with v3 randomization factors."
},
"RandomizationFactorGroupV3Doc":{
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Question or factor unique identifier.",
"format":"uuid"
},
"formTitle":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Form title containing the factor.",
"example":"Demography"
},
"questionTitle":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Question title displayed to study designers.",
"example":"Age"
},
"groupName":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Stratum or cohort group name.",
"example":"Group Name 1"
},
"groupId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Stratum or cohort group unique identifier.",
"format":"uuid"
},
"formCategory":{
"maxLength":3,
"minLength":3,
"type":"string",
"description":"Form category for the factor.",
"example":"DCS"
},
"formSubcategory":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Form subcategory for the factor when present.",
"example":"Baseline"
},
"instructionalText":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Instructional text configured for the factor question.",
"example":"Select participant age range"
},
"parentCohortId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Parent cohort unique identifier when the factor belongs to a cohort.",
"format":"uuid"
},
"parentCohortName":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Parent cohort name when the factor belongs to a cohort.",
"example":"Adult Cohort"
}
},
"description":"Form item group details returned for a randomization factor."
},
"RandomizationFactorsItemV3":{
"type":"object",
"properties":{
"details":{
"$ref":"#/components/schemas/RandomizationDetailsV3Doc"
},
"groups":{
"minItems":0,
"type":"array",
"description":"Form item groups returned for the selected randomization factor type.",
"example":[
{
"id":"B1B8327AFAA6412287106192AB5984EF",
"formTitle":"Demography",
"questionTitle":"Age",
"groupName":"Group Name 1",
"groupId":"A1B8327AFAA6412287106192AB5984EF",
"formCategory":"DCS",
"formSubcategory":"Baseline",
"instructionalText":"Select participant age range",
"parentCohortId":"C1B8327AFAA6412287106192AB5984EF",
"parentCohortName":"Adult Cohort"
}
],
"items":{
"$ref":"#/components/schemas/RandomizationFactorGroupV3Doc"
}
}
},
"description":"Randomization factor details returned by the v3 get randomization factors endpoint."
},
"StrataBulkFactorV3":{
"type":"object",
"properties":{
"type":{
"maxLength":6,
"minLength":5,
"type":"string",
"description":"Factor type. Allowed values: choice = factor based on one or more coded choice values, range = factor based on a numeric range.",
"example":"choice",
"enum":[
"choice",
"range"
]
},
"formId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Form unique identifier that owns the factor item.",
"format":"uuid"
},
"itemId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Form item unique identifier for the factor item.",
"format":"uuid"
},
"groupName":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Factor group display name.",
"example":"Age Group"
},
"groupId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Factor group unique identifier.",
"format":"uuid"
},
"values":{
"type":"array",
"description":"Selected display values for a choice-based factor.",
"example":[
"18-40",
"41-65"
],
"items":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"18-40"
}
},
"codelistitemIds":{
"type":"array",
"description":"Selected code list item identifiers for a choice-based factor.",
"example":[
"977443BF3EFB43888026788E7F7CCE96",
"877443BF3EFB43888026788E7F7CCE95"
],
"items":{
"maxLength":32,
"minLength":32,
"type":"string",
"format":"uuid"
}
},
"min":{
"type":"number",
"description":"Minimum numeric value for a range-based factor. Negative values are allowed when the linked numeric form item permits them.",
"format":"double",
"example":18
},
"max":{
"type":"number",
"description":"Maximum numeric value for a range-based factor. Negative values are allowed when the linked numeric form item permits them.",
"format":"double",
"example":30
}
},
"description":"Stratification factor details used in bulk strata request and response payloads."
},
"StrataBulkItemV3":{
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Stratum unique identifier.",
"format":"uuid"
},
"name":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Stratum display name.",
"example":"Stratum Group 1"
},
"parentCohortName":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Parent cohort name when the stratum belongs to a cohort.",
"example":"Adult Cohort"
},
"parentCohortId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Parent cohort unique identifier when the stratum belongs to a cohort.",
"format":"uuid"
},
"factors":{
"type":"array",
"description":"Stratification factors associated with the stratum.",
"example":[
{
"type":"choice",
"formId":"D1B8327AFAA6412287106192AB5984EF",
"itemId":"E1B8327AFAA6412287106192AB5984EF",
"groupName":"Age Group",
"groupId":"F1B8327AFAA6412287106192AB5984EF",
"values":[
"18-40",
"41-65"
],
"codelistitemIds":[
"977443BF3EFB43888026788E7F7CCE96",
"877443BF3EFB43888026788E7F7CCE95"
]
}
],
"items":{
"$ref":"#/components/schemas/StrataBulkFactorV3"
}
},
"weight":{
"minimum":0,
"type":"integer",
"description":"Weight assigned to the stratum when weighted selection is used.",
"format":"int32",
"example":1
},
"randomizationType":{
"maxLength":19,
"minLength":10,
"type":"string",
"description":"Randomization type for the stratum. Allowed values: Stratified = standard stratified randomization stratum, Adaptive Stratified = adaptive stratified randomization stratum.",
"example":"Stratified",
"enum":[
"Stratified",
"Adaptive Stratified"
]
},
"objectType":{
"maxLength":9,
"minLength":4,
"type":"string",
"description":"Object type used by adaptive strata. Allowed values: Code List = coded factor source, Site = site-based factor source, Country = country-based factor source, Region = region-based factor source.",
"example":"Code List",
"enum":[
"Code List",
"Site",
"Country",
"Region"
]
},
"objectId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Object unique identifier associated with the objectType.",
"format":"uuid"
}
},
"description":"Bulk strata request and response payload item for the v3 strata APIs."
},
"RqstStratumDto":{
"required":[
"name"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Stratum Unique GUID",
"format":"uuid"
},
"name":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Stratum Name",
"example":"Stratum Group 1"
},
"parentCohortName":{
"type":"string",
"description":"Name of the Parent Cohort"
},
"parentCohortId":{
"type":"string",
"description":"Parent Cohort Id",
"format":"uuid"
},
"factors":{
"type":"array",
"items":{
"$ref":"#/components/schemas/StratumFactorDtoV3"
}
},
"weight":{
"type":"string",
"description":"Weight of Stratum Group",
"example":"1"
},
"randomizationType":{
"type":"string",
"description":"Type of Stratum",
"example":"Stratified"
},
"objectType":{
"type":"string",
"description":"Type of Object",
"example":"Code List"
},
"objectId":{
"type":"string",
"description":"Value of Object GUID",
"example":"B1B8327AFAA6412287106192AB5984EF"
}
}
},
"StratumChoiceFactorDtoV3":{
"title":"StratumChoiceFactorDto v3.0",
"required":[
"codelistitemIds",
"formId",
"itemId",
"values"
],
"type":"object",
"description":"Stratum Choice Factor Detail Information",
"allOf":[
{
"$ref":"#/components/schemas/StratumFactorDtoV3"
},
{
"type":"object",
"properties":{
"values":{
"maxItems":2147483647,
"minItems":1,
"type":"array",
"items":{
"maxLength":2147483647,
"minLength":1,
"type":"string",
"description":"Selected from choice factor's code list choice values",
"example":"1"
}
},
"codelistitemIds":{
"maxItems":2147483647,
"minItems":1,
"type":"array",
"items":{
"type":"string",
"description":"Selected from choice factor's code list choice codelistItem Ids",
"format":"uuid"
}
}
}
}
]
},
"StratumFactorDtoV3":{
"title":"StratumFactorDto v3.0",
"required":[
"formId",
"itemId",
"type"
],
"type":"object",
"properties":{
"formId":{
"type":"string",
"description":"Form GUID",
"format":"uuid"
},
"itemId":{
"type":"string",
"description":"Form item GUID",
"format":"uuid"
},
"groupName":{
"type":"string",
"description":"Stratum Name",
"example":"Stratum Group 1"
},
"groupId":{
"type":"string",
"description":"Stratum Group Id",
"format":"uuid"
},
"type":{
"type":"string"
}
},
"description":"Randomization Stratum Factor Information",
"discriminator":{
"propertyName":"type",
"mapping":{
"choice":"#/components/schemas/StratumChoiceFactorDtoV3",
"range":"#/components/schemas/StratumRangeFactorDtoV3"
}
},
"oneOf":[
{
"$ref":"#/components/schemas/StratumChoiceFactorDtoV3"
},
{
"$ref":"#/components/schemas/StratumRangeFactorDtoV3"
}
]
},
"StratumRangeFactorDtoV3":{
"title":"StratumRangeFactorDto v3.0",
"required":[
"formId",
"itemId",
"max",
"min"
],
"type":"object",
"description":"Stratum Range Factor Detail Information",
"allOf":[
{
"$ref":"#/components/schemas/StratumFactorDtoV3"
},
{
"type":"object",
"properties":{
"min":{
"type":"number",
"description":"Stratum Factor Min value",
"format":"double",
"example":20
},
"max":{
"type":"number",
"description":"Stratum Factor Max value",
"format":"double",
"example":120
}
}
}
]
},
"StrataFactorV4":{
"type":"object",
"properties":{
"type":{
"maxLength":6,
"minLength":5,
"type":"string",
"description":"Factor type. Allowed values: choice = factor based on one or more coded choice values, range = factor based on a numeric range.",
"example":"choice",
"enum":[
"choice",
"range"
]
},
"formId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Form unique identifier that owns the factor item.",
"format":"uuid"
},
"itemId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Form item unique identifier for the factor item.",
"format":"uuid"
},
"groupName":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Factor group display name.",
"example":"Age Group"
},
"groupId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Factor group unique identifier.",
"format":"uuid"
},
"values":{
"type":"array",
"description":"Selected code list values for a choice factor.",
"example":[
"18-40",
"41-65"
],
"items":{
"maxLength":255,
"minLength":1,
"type":"string",
"example":"18-40"
}
},
"codelistitemIds":{
"type":"array",
"description":"Identifiers of the selected code list items for a choice factor.",
"example":[
"977443BF3EFB43888026788E7F7CCE96",
"877443BF3EFB43888026788E7F7CCE95"
],
"items":{
"maxLength":32,
"minLength":32,
"type":"string",
"format":"uuid"
}
},
"min":{
"type":"number",
"description":"Minimum numeric value for a range factor. Negative values are allowed when supported by the linked numeric form item's validation range.",
"format":"double",
"example":-5
},
"max":{
"type":"number",
"description":"Maximum numeric value for a range factor. Negative values are allowed when supported by the linked numeric form item's validation range.",
"format":"double",
"example":30
}
},
"description":"Factor details returned for a v4 stratum."
},
"StrataItemV4":{
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Stratum unique identifier.",
"format":"uuid"
},
"name":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Stratum display name.",
"example":"Minimization Group 1"
},
"parentCohortId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Parent cohort unique identifier when the stratum belongs to a cohort.",
"format":"uuid"
},
"parentCohortName":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Parent cohort name when the stratum belongs to a cohort.",
"example":"Adult Cohort"
},
"weight":{
"minimum":0,
"type":"integer",
"description":"Weight assigned to the stratum when weighted selection is used.",
"format":"int32",
"example":1
},
"randomizationType":{
"maxLength":14,
"minLength":7,
"type":"string",
"description":"Randomization type for the returned stratum. Allowed values: STRATUM = standard stratified randomization stratum, ADAPTIVESTRATUM = adaptive stratified randomization stratum, MINIMIZATION = minimization randomization stratum.",
"example":"MINIMIZATION",
"enum":[
"STRATUM",
"ADAPTIVESTRATUM",
"MINIMIZATION"
]
},
"objectType":{
"maxLength":12,
"minLength":8,
"type":"string",
"description":"Object type for minimization strata. Allowed values: FORMITEM = minimization factor sourced from a form item, CLCODEVALUES = minimization factor sourced from configured code list values. This field can be null for non-minimization strata.",
"example":"CLCODEVALUES",
"enum":[
"FORMITEM",
"CLCODEVALUES"
]
},
"objectId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Object unique identifier associated with the objectType.",
"format":"uuid"
},
"factors":{
"type":"array",
"description":"Stratification factors used to define the stratum.",
"example":[
{
"type":"choice",
"formId":"D1B8327AFAA6412287106192AB5984EF",
"itemId":"E1B8327AFAA6412287106192AB5984EF",
"groupName":"Age Group",
"groupId":"F1B8327AFAA6412287106192AB5984EF",
"values":[
"18-40",
"41-65"
],
"codelistitemIds":[
"977443BF3EFB43888026788E7F7CCE96",
"877443BF3EFB43888026788E7F7CCE95"
]
}
],
"items":{
"$ref":"#/components/schemas/StrataFactorV4"
}
}
},
"description":"Stratum details returned by the v4 strata read APIs."
},
"KitsAllItemV6":{
"type":"object",
"properties":{
"kitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Kit unique identifier.",
"format":"uuid"
},
"kitTypeId":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Kit type identifier.",
"example":"KIT_STD_001"
},
"kitDescription":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Kit description displayed to study designers.",
"example":"Standard treatment kit"
},
"distributionSetting":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Distribution setting for the kit. Allowed values: BLINDED = treatment assignment remains hidden, UNBLINDED = treatment assignment is visible, UNBLINDEDPHARMAC = treatment assignment is visible for pharmacy-managed workflows.",
"example":"UNBLINDED",
"enum":[
"BLINDED",
"UNBLINDED",
"UNBLINDEDPHARMAC"
]
},
"deviceType":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Device type for device kits. Allowed values: ActivityWatch, BloodPressureMonitor, WeightScale, ECGReader, Spirometer, MobileApp, SmartPillBottle, PulseOximeter, WearablePatch, Other, GlucoseMonitor.",
"example":"WeightScale",
"enum":[
"ActivityWatch",
"BloodPressureMonitor",
"WeightScale",
"ECGReader",
"Spirometer",
"MobileApp",
"SmartPillBottle",
"PulseOximeter",
"WearablePatch",
"Other",
"GlucoseMonitor"
]
},
"deviceConn":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Device connectivity type. Allowed values: CloudtoCloud = sync through an external cloud, DevicetoCloud = device sends data directly to the platform cloud, NoConnection = no connectivity is required.",
"example":"DevicetoCloud",
"enum":[
"CloudtoCloud",
"DevicetoCloud",
"NoConnection"
]
},
"trialSupplyType":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Trial supply type for the kit. Allowed values: BLISTERPACK, BOTTLE, DEVICE, SYRINGE, OINTMENT, VIAL, INHALER, INFUSION, BOX, OTHER.",
"example":"BOTTLE",
"enum":[
"BLISTERPACK",
"BOTTLE",
"DEVICE",
"SYRINGE",
"OINTMENT",
"VIAL",
"INHALER",
"INFUSION",
"BOX",
"OTHER"
]
},
"titrationKit":{
"type":"boolean",
"description":"Indicates whether the kit is configured as a titration kit.",
"example":false
},
"libraryKitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Library kit unique identifier when the kit is based on a library kit.",
"format":"uuid"
},
"poolingId":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Pooling identifier for pooled kit configurations.",
"example":"POOL12"
},
"serialized":{
"type":"boolean",
"description":"Indicates whether the kit is serialized.",
"example":true
}
},
"description":"Kit summary returned by the v6 get-all-kits endpoint."
},
"RandomizationArmV6Doc":{
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Treatment arm unique identifier.",
"format":"uuid"
},
"name":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Treatment arm name.",
"example":"Arm A"
},
"ratio":{
"maximum":99,
"minimum":1,
"type":"integer",
"description":"Treatment arm allocation ratio. Allowed numeric range is 1 through 99. Zero and negative values are not allowed.",
"format":"int32",
"example":2
}
},
"description":"Treatment arm ratio configured for the randomization design."
},
"RandomizationDetailsV6Doc":{
"type":"object",
"properties":{
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Randomization title.",
"example":"Rand 001"
},
"description":{
"maxLength":4000,
"minLength":1,
"type":"string",
"description":"Randomization design description.",
"example":"Method to assign study participants to a treatment group."
},
"algorithm":{
"maxLength":31,
"minLength":4,
"type":"string",
"description":"Randomization algorithm. Allowed values: None = no randomization algorithm configured, Central = centrally managed randomization without stratification, CentralStratified = central stratified randomization, SiteBlockedFixed = site-blocked fixed randomization, SiteBlockedFixedStratified = site-blocked fixed stratified randomization, SiteBlockedDynamic = site-blocked dynamic randomization, SiteBlockedDynamicStratified = site-blocked dynamic stratified randomization, CountryBlockedFixed = country-blocked fixed randomization, CountryBlockedFixedStratified = country-blocked fixed stratified randomization, CountryBlockedDynamic = country-blocked dynamic randomization, CountryBlockedDynamicStratified = country-blocked dynamic stratified randomization, RegionBlockedFixed = region-blocked fixed randomization, RegionBlockedFixedStratified = region-blocked fixed stratified randomization, RegionBlockedDynamic = region-blocked dynamic randomization, RegionBlockedDynamicStratified = region-blocked dynamic stratified randomization, Minimization = minimization algorithm.",
"example":"Central",
"enum":[
"None",
"Central",
"CentralStratified",
"SiteBlockedFixed",
"SiteBlockedFixedStratified",
"SiteBlockedDynamic",
"SiteBlockedDynamicStratified",
"CountryBlockedFixed",
"CountryBlockedFixedStratified",
"CountryBlockedDynamic",
"CountryBlockedDynamicStratified",
"RegionBlockedFixed",
"RegionBlockedFixedStratified",
"RegionBlockedDynamic",
"RegionBlockedDynamicStratified",
"Minimization"
]
},
"cohortType":{
"maxLength":10,
"minLength":7,
"type":"string",
"description":"Cohort behavior for the randomization design. Allowed values: NoCohort = no cohorting is applied, Adaptive = adaptive cohorts are used, Demography = demographic cohorts are used, invalid = unrecognized persisted value.",
"example":"NoCohort",
"enum":[
"NoCohort",
"Adaptive",
"Demography",
"invalid"
]
},
"randomizationType":{
"maxLength":9,
"minLength":7,
"type":"string",
"description":"Randomization blinding type. Allowed values: Blinded = subject assignments remain blinded, Unblinded = subject assignments are visible, invalid = unrecognized persisted value.",
"example":"Blinded",
"enum":[
"Blinded",
"Unblinded",
"invalid"
]
},
"reRandomization":{
"type":"boolean",
"description":"Indicates whether re-randomization is enabled.",
"example":true
},
"treatmentArms":{
"maxLength":10,
"minLength":4,
"type":"string",
"description":"Treatment arm assignment mode. Allowed values: Randomized = arms are assigned by the randomization algorithm, Mapped = arms are mapped explicitly, None = no treatment arms are configured, invalid = unrecognized persisted value.",
"example":"Randomized",
"enum":[
"Randomized",
"Mapped",
"None",
"invalid"
]
}
},
"description":"Details for the randomization design.",
"example":{
"title":"Rand 001",
"description":"Method to assign study participants to a treatment group.",
"algorithm":"Central",
"cohortType":"NoCohort",
"randomizationType":"Blinded",
"reRandomization":true,
"treatmentArms":"Randomized"
}
},
"RandomizationErrorV6":{
"type":"object",
"properties":{
"errorCode":{
"maxLength":32,
"minLength":1,
"type":"string",
"description":"Application error code.",
"example":"C1-400"
},
"errorMessage":{
"maxLength":1024,
"minLength":1,
"type":"string",
"description":"Human-readable error message.",
"example":"Randomization details are invalid"
},
"details":{
"type":"object",
"description":"Request-specific error details object.",
"example":{
"field":"details.title",
"message":"must not be blank"
}
}
},
"description":"Error payload returned by the v6 randomization endpoints.",
"nullable":true,
"example":{
"errorCode":"C1-400",
"errorMessage":"Randomization details are invalid",
"details":{
"field":"details.title",
"message":"must not be blank"
}
}
},
"RandomizationPayloadV6":{
"type":"object",
"properties":{
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Randomization unique identifier.",
"format":"uuid"
},
"versionStart":{
"maxLength":40,
"minLength":20,
"type":"string",
"description":"Version start timestamp for the randomization design.",
"format":"date-time",
"example":"2025-01-17T15:41:10.733Z"
},
"details":{
"$ref":"#/components/schemas/RandomizationDetailsV6Doc"
},
"arms":{
"type":"array",
"description":"Treatment arms configured for the randomization design.",
"example":[
{
"id":"C1B8327AFAA6412287106192AB5984EF",
"name":"Arm A",
"ratio":2
}
],
"items":{
"$ref":"#/components/schemas/RandomizationArmV6Doc"
}
},
"visits":{
"type":"array",
"description":"Visits that participate in randomization.",
"example":[
{
"visitId":"E1B8327AFAA6412287106192AB5984EF",
"visitName":"Week 1",
"branchId":"F1B8327AFAA6412287106192AB5984EF"
}
],
"items":{
"$ref":"#/components/schemas/RandomizationVisitV6Doc"
}
},
"settings":{
"$ref":"#/components/schemas/RandomizationSettingsV6Doc"
}
},
"description":"Randomization design payload used by the v6 create and update randomization endpoints."
},
"RandomizationResponseV6":{
"type":"object",
"properties":{
"status":{
"maxLength":7,
"minLength":7,
"type":"string",
"description":"Envelope status returned by the endpoint. Allowed value: success.",
"example":"success",
"enum":[
"success"
]
},
"result":{
"$ref":"#/components/schemas/RandomizationPayloadV6"
},
"errorData":{
"$ref":"#/components/schemas/RandomizationErrorV6"
},
"version":{
"minimum":1,
"type":"integer",
"description":"Envelope version for the shared Designer response wrapper.",
"format":"int32",
"example":1
}
},
"description":"Designer response envelope returned by the v6 randomization create and update endpoints."
},
"RandomizationSettingsV6Doc":{
"type":"object",
"properties":{
"randomizeSubjectsIfSitesOutOfKits":{
"type":"boolean",
"description":"Indicates whether randomization should continue when sites are out of kits.",
"example":false
},
"assignSkippedRandomizationNumbers":{
"type":"boolean",
"description":"Indicates whether skipped randomization numbers should be assigned.",
"example":false
},
"randomizeNumberBlinded":{
"type":"boolean",
"description":"Indicates whether randomization numbers are blinded.",
"example":true
},
"randomizeLimitsToCountEarlyTerminated":{
"type":"boolean",
"description":"Indicates whether early terminated subjects count toward randomization limits.",
"example":false
},
"assignNewRandomizeNumbers":{
"type":"boolean",
"description":"Indicates whether new randomization numbers are assigned to all subjects.",
"example":true
},
"allowOutsideWindow":{
"type":"boolean",
"description":"Indicates whether randomization is allowed outside the schedule window.",
"example":false
}
},
"description":"Settings that control randomization number handling and visit-window behavior.",
"example":{
"randomizeSubjectsIfSitesOutOfKits":false,
"assignSkippedRandomizationNumbers":false,
"randomizeNumberBlinded":true,
"randomizeLimitsToCountEarlyTerminated":false,
"assignNewRandomizeNumbers":true,
"allowOutsideWindow":false
}
},
"RandomizationVisitV6Doc":{
"type":"object",
"properties":{
"visitId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Visit unique identifier.",
"format":"uuid"
},
"visitName":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Visit name.",
"example":"Week 1"
},
"branchId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Branch unique identifier for the visit path.",
"format":"uuid"
}
},
"description":"Visit included in the randomization design."
},
"RandomizationArmV5":{
"title":"RandomizationArm v5.0",
"required":[
"id",
"ratio"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Treatment Arm GUID",
"format":"uuid"
},
"name":{
"type":"string",
"description":"Treatment Arm Name",
"example":"Arm1"
},
"ratio":{
"maximum":99,
"minimum":1,
"type":"integer",
"description":"The ratio defined for the treatment arm",
"format":"int32",
"example":2,
"enum":[
null
]
}
},
"description":"Randomization Design Treatment Arm Ratio"
},
"RandomizationDetailsV5":{
"title":"RandomizationDetails v5.0",
"required":[
"algorithm",
"cohortType",
"randomizationType",
"title"
],
"type":"object",
"properties":{
"title":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Randomization Title",
"example":"Rand 001"
},
"description":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Randomization Design Description",
"example":"Method to assign study participants to a treatment group."
},
"algorithm":{
"type":"string",
"description":"The algorithm of the randomization design",
"example":"Central",
"enum":[
"NONE",
"CENTRAL",
"CENTRAL_STRATIFIED",
"SITE_BLOCKED_FIXED",
"SITE_BLOCKED_FIXED_STRATIFIED",
"SITE_BLOCKED_DYNAMIC",
"SITE_BLOCKED_DYNAMIC_STRATIFIED",
"COUNTRY_BLOCKED_FIXED",
"COUNTRY_BLOCKED_FIXED_STRATIFIED",
"COUNTRY_BLOCKED_DYNAMIC",
"COUNTRY_BLOCKED_DYNAMIC_STRATIFIED",
"REGION_BLOCKED_FIXED",
"REGION_BLOCKED_FIXED_STRATIFIED",
"REGION_BLOCKED_DYNAMIC",
"REGION_BLOCKED_DYNAMIC_STRATIFIED",
"MINIMIZATION"
]
},
"cohortType":{
"type":"string",
"description":"The cohort type of the randomization design",
"example":"None",
"enum":[
"NoCohort",
"Adaptive",
"Demography",
"invalid"
]
},
"randomizationType":{
"type":"string",
"description":"Type of the randomization design",
"example":"Blinded",
"enum":[
"Blinded",
"Unblinded",
"invalid"
]
},
"reRandomization":{
"type":"boolean",
"description":"Whether to use re-randomization on the randomization design",
"example":true
},
"treatmentArms":{
"type":"string",
"description":"Whether to use randomized or mapped on the randomization design",
"example":"Randomized",
"enum":[
"Randomized",
"Mapped",
"None",
"invalid"
]
}
},
"description":"Details of the randomization design."
},
"RandomizationSettingsV5":{
"title":"RandomizationSettings v5.0",
"type":"object",
"properties":{
"randomizeSubjectsIfSitesOutOfKits":{
"type":"boolean",
"description":"Whether to restrict randomization numbers to available kit types",
"example":false
},
"assignSkippedRandomizationNumbers":{
"type":"boolean",
"description":"Whether to assign skipped randomization numbers",
"example":false
},
"randomizeNumberBlinded":{
"type":"boolean",
"description":"Whether to use blinded randomization numbers",
"example":false
},
"randomizeLimitsToCountEarlyTerminated":{
"type":"boolean",
"description":"Whether limits include withdrawn subjects",
"example":false
},
"assignNewRandomizeNumbers":{
"type":"boolean",
"description":"Whether to assign new randomization numbers to all subjects",
"example":false
},
"allowOutsideWindow":{
"type":"boolean",
"description":"Whether to allow randomization outside schedule window",
"example":false
}
},
"description":"The settings for the randomization design."
},
"RandomizationVisitV5":{
"title":"RandomizationVisit v5.0",
"required":[
"visitId"
],
"type":"object",
"properties":{
"visitId":{
"type":"string",
"description":"Visit GUID",
"format":"uuid"
},
"visitName":{
"type":"string",
"description":"Visit name",
"example":"Week 3"
},
"branchId":{
"type":"string",
"description":"The id of the branch",
"format":"uuid"
}
},
"description":"Randomization Visit"
},
"RqstRandomizationDto":{
"required":[
"details",
"settings"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Randomization GUID",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"Randomization VersionStart",
"format":"date-time",
"example":"2021-01-17T15:41:10.733Z"
},
"details":{
"$ref":"#/components/schemas/RandomizationDetailsV5"
},
"arms":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationArmV5"
}
},
"visits":{
"type":"array",
"items":{
"$ref":"#/components/schemas/RandomizationVisitV5"
}
},
"settings":{
"$ref":"#/components/schemas/RandomizationSettingsV5"
}
}
},
"DispensingErrorParamListV7":{
"type":"object",
"properties":{
"ErrorParam":{
"type":"array",
"description":"Error parameters associated with the row.",
"example":[
{
"key":"A1B8327AFAA6412287106192AB5984EF",
"type":"Visit",
"id":"A1B8327AFAA6412287106192AB5984EF",
"name":"Week 1"
}
],
"items":{
"$ref":"#/components/schemas/DispensingErrorParamV7"
}
}
},
"description":"Collection of error parameters associated with a dispensation row."
},
"DispensingErrorParamV7":{
"type":"object",
"properties":{
"key":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Unique key for the missing or invalid object reference.",
"format":"uuid"
},
"type":{
"maxLength":6,
"minLength":4,
"type":"string",
"description":"Object type associated with the error. Allowed values: Dosing = missing dosing reference, Visit = missing visit reference, Form = missing form reference.",
"example":"Visit",
"enum":[
"Dosing",
"Visit",
"Form"
]
},
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Unique identifier of the referenced object.",
"format":"uuid"
},
"name":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Display name of the referenced object.",
"example":"Week 1"
}
},
"description":"Error parameter identifying a missing or invalid object reference."
},
"DispensingRowResponseV7":{
"type":"object",
"properties":{
"kitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Kit unique identifier.",
"format":"uuid"
},
"armid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Treatment arm unique identifier.",
"format":"uuid"
},
"visitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Visit unique identifier.",
"format":"uuid"
},
"adGroupId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Advanced dosing group unique identifier when advanced dosing selected this row.",
"format":"uuid"
},
"dosingId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dosing unique identifier associated with the row.",
"format":"uuid"
},
"quantity":{
"maximum":9999,
"minimum":1,
"type":"integer",
"description":"Quantity of kits or dose to dispense. Allowed numeric range is 1 through 9999. Zero and negative values are not allowed.",
"format":"int64",
"example":1
},
"dnd":{
"maximum":9999,
"minimum":0,
"type":"integer",
"description":"Do-not-dispense threshold in days before kit expiration. Allowed numeric range is 0 through 9999. Negative values are not allowed.",
"format":"int64",
"example":5
},
"dispenseoutsidewindow":{
"type":"boolean",
"description":"Indicates whether the kit can be dispensed outside the visit window.",
"example":false
},
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dispensing row unique identifier.",
"format":"uuid"
},
"allowTitration":{
"type":"boolean",
"description":"Indicates whether titration is allowed for the row.",
"example":true
},
"titrationKits":{
"type":"array",
"description":"Titration kits associated with the dispensation row.",
"example":[
{
"kitTypeId":"KIT_STD_001",
"kitid":"B1B8327AFAA6412287106192AB5984EF",
"kitQuantity":1
}
],
"items":{
"$ref":"#/components/schemas/DispensingTitrationKitV7"
}
},
"blindedInfo":{
"$ref":"#/components/schemas/KitsGetKitV10Doc"
},
"errorParamList":{
"type":"array",
"description":"Validation or resolution error parameter groups associated with the dispensation row.",
"example":[
{
"ErrorParam":[
{
"key":"A1B8327AFAA6412287106192AB5984EF",
"type":"Visit",
"id":"A1B8327AFAA6412287106192AB5984EF",
"name":"Week 1"
}
]
}
],
"items":{
"$ref":"#/components/schemas/DispensingErrorParamListV7"
}
}
},
"description":"Dispensing visit row returned by the v7 get and update dispensings endpoints."
},
"DispensingTitrationKitV7":{
"type":"object",
"properties":{
"kitTypeId":{
"maxLength":64,
"minLength":1,
"type":"string",
"description":"Kit type identifier for the titration kit.",
"example":"KIT_STD_001"
},
"kitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Titration kit unique identifier.",
"format":"uuid"
},
"kitQuantity":{
"maximum":9999,
"minimum":1,
"type":"integer",
"description":"Quantity of kits dispensed for the titration entry. Allowed numeric range is 1 through 9999. Zero and negative values are not allowed.",
"format":"int64",
"example":1
}
},
"description":"Titration kit summary associated with a dispensation row."
},
"DispensingRowRequestV7":{
"type":"object",
"properties":{
"kitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Kit unique identifier.",
"format":"uuid"
},
"armid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Treatment arm unique identifier.",
"format":"uuid"
},
"visitid":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Visit unique identifier.",
"format":"uuid"
},
"adGroupId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Advanced dosing group unique identifier when advanced dosing selected this row.",
"format":"uuid"
},
"dosingId":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dosing unique identifier associated with the row.",
"format":"uuid"
},
"quantity":{
"maximum":9999,
"minimum":1,
"type":"integer",
"description":"Quantity of kits or dose to dispense. Allowed numeric range is 1 through 9999. Zero and negative values are not allowed.",
"format":"int64",
"example":1
},
"dnd":{
"maximum":9999,
"minimum":0,
"type":"integer",
"description":"Do-not-dispense threshold in days before kit expiration. Allowed numeric range is 0 through 9999. Negative values are not allowed.",
"format":"int64",
"example":5
},
"dispenseoutsidewindow":{
"type":"boolean",
"description":"Indicates whether the kit can be dispensed outside the visit window.",
"example":false
},
"id":{
"maxLength":32,
"minLength":32,
"type":"string",
"description":"Dispensing row unique identifier.",
"format":"uuid"
},
"allowTitration":{
"type":"boolean",
"description":"Indicates whether titration is allowed for the row.",
"example":true
},
"titrationKits":{
"type":"array",
"description":"Titration kits associated with the dispensation row.",
"example":[
{
"kitTypeId":"KIT_STD_001",
"kitid":"B1B8327AFAA6412287106192AB5984EF",
"kitQuantity":1
}
],
"items":{
"$ref":"#/components/schemas/DispensingTitrationKitV7"
}
},
"blindedInfo":{
"$ref":"#/components/schemas/KitsGetKitV10Doc"
}
},
"description":"Dispensing visit row used by the v7 update dispensings endpoint."
},
"ValidationResult":{
"type":"object",
"properties":{
"message":{
"type":"object",
"properties":{
"empty":{
"type":"boolean"
},
"length":{
"type":"integer",
"format":"int32",
"writeOnly":true
}
}
},
"valid":{
"type":"boolean"
}
}
},
"BaseResponse":{
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Response status for the request; typically 'success' or 'error'.",
"example":"success"
},
"result":{
"type":"object",
"description":"Generic result for all request entity types. The type returned depends on endpoint. May be ExecutionLog, list, or error data."
},
"ErrorResponseData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
},
"description":"Base response object for all reporting service endpoints, providing a standard structure for status, result, and errorData."
},
"NotificationPayload":{
"type":"object",
"properties":{
"fieldKey":{
"type":"string",
"description":"Unique field identifier/key for the notification.",
"example":"subjectId"
},
"fieldName":{
"type":"string",
"description":"Display name for the notification field.",
"example":"Subject ID"
},
"fieldValue":{
"type":"string",
"description":"Value for the notification field.",
"example":"SUBJ001"
}
},
"description":"Represents a notification detail with key and value."
},
"NotificationPayloadWrapper":{
"type":"object",
"properties":{
"notificationPayloads":{
"type":"array",
"writeOnly":true,
"items":{
"$ref":"#/components/schemas/NotificationPayload"
}
}
},
"description":"Request payload wrapper for notification: a map from notification field key to NotificationPayload."
},
"notificationPayloadMap":{
"type":"object",
"description":"Map from notification key to notification payload.",
"example":{
"subjectId":{
"fieldKey":"subjectId",
"fieldName":"Subject ID",
"fieldValue":"SUBJ001"
},
"visit":{
"fieldKey":"visit",
"fieldName":"Visit",
"fieldValue":"SCREENING"
}
}
},
"ExecutionLog":{
"required":[
"rptFormat",
"rptKickoffDatetime",
"rptName",
"userId",
"versionEnd",
"versionStart"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Primary key. Unique job execution identifier (UUID). Example: 'BBAACF7D12C245A2A59B1C23DEADBEEF'",
"format":"uuid"
},
"rptId":{
"type":"string",
"description":"Report template identifier (UUID). Example: 'AABB1234DD884FA1A9DC1AFDECBA1A35'",
"format":"uuid"
},
"versionStart":{
"type":"string",
"description":"Job execution version start timestamp (ISO-8601 date/time). Example: '2025-10-27T10:00:00.123Z'",
"format":"date-time",
"example":"2025-10-27T10:00:00.123Z"
},
"runDuration":{
"type":"integer",
"description":"Job execution run duration in milliseconds",
"format":"int64"
},
"userId":{
"type":"string",
"description":"User identifier (UUID) who initiated or owns the job. Example: '123E4567E89B12D3A456426614174000'",
"format":"uuid"
},
"versionEnd":{
"type":"string",
"description":"Job execution version end timestamp (ISO-8601 date/time). Example: '2025-10-27T10:30:00.789Z'",
"format":"date-time",
"example":"2025-10-27T10:30:00.789Z"
},
"operationType":{
"maxLength":1024,
"minLength":0,
"type":"string",
"description":"Database action or type of operation represented by this job record. (E.g. INSERT, UPDATE, DELETE)"
},
"reason":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Reason provided for status or operation (e.g. failed status explanation)"
},
"comment":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"User-provided free-form comment about this execution"
},
"rptKickoffDatetime":{
"type":"string",
"description":"Date/time the report run started (ISO-8601 date/time). Example: '2025-10-27T10:00:00.000Z'",
"format":"date-time",
"example":"2025-10-27T10:00:00Z"
},
"rptName":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Report name. Example: 'Subject Listing'",
"example":"Subject Listing"
},
"rptStatCd":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Report status code (business state of run, e.g. SUCCESS, FAILED, SUBMITTED, IN_PROGRESS)",
"example":"SUCCESS"
},
"rptFormat":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Format of generated report. Enumerated (PDF, XLSX, etc.)",
"example":"PDF"
},
"recCount":{
"type":"integer",
"description":"Total number of records in this report run (if known)",
"format":"int32"
},
"currSearchSpec":{
"maxLength":32000,
"minLength":0,
"type":"string",
"description":"Search specification filter string for this run (may be large)"
},
"currSortSpec":{
"maxLength":512,
"minLength":0,
"type":"string",
"description":"Sort specification string for this report run"
},
"objectVersionNumber":{
"type":"number",
"description":"Object version field (for optimistic concurrency/locking)"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software/application version field (build or runtime version, if needed)"
},
"fileStorageId":{
"type":"string",
"description":"ID of the associated report file blob in storage (UUID)",
"format":"uuid"
}
}
},
"DirectReportPayload":{
"type":"object",
"properties":{
"reportSection":{
"$ref":"#/components/schemas/DirectReportSection"
}
},
"description":"Payload object for direct report generation. Contains report sections details."
},
"DirectReportSection":{
"type":"object",
"properties":{
"rptName":{
"type":"string",
"description":"Name of the report section.",
"example":"Subject Visit"
},
"rptSeq":{
"type":"integer",
"description":"Section sequence number.",
"format":"int32",
"example":1
},
"result":{
"$ref":"#/components/schemas/SectionData"
},
"sectiondata":{
"$ref":"#/components/schemas/SectionData"
}
},
"description":"Section in a direct report payload, includes report name, sequence, and results."
},
"SectionData":{
"type":"object",
"properties":{
"count":{
"type":"integer",
"description":"Total number of data rows in this section.",
"format":"int32",
"example":2
},
"data":{
"type":"array",
"description":"2D array representing the tabular data for the section, matching the columns and rows.",
"example":[
[
"1001",
"2025-11-04",
"BASELINE"
],
[
"1002",
"2025-11-05",
"SCREENING"
]
],
"items":{
"type":"array",
"description":"2D array representing the tabular data for the section, matching the columns and rows.",
"example":[
[
"1001",
"2025-11-04",
"BASELINE"
],
[
"1002",
"2025-11-05",
"SCREENING"
]
],
"items":{
"type":"string",
"description":"2D array representing the tabular data for the section, matching the columns and rows.",
"example":"[[\"1001\",\"2025-11-04\",\"BASELINE\"],[\"1002\",\"2025-11-05\",\"SCREENING\"]]"
}
}
},
"columns":{
"type":"array",
"description":"Column headers for the data grid.",
"example":[
"Subject Id",
"Visit Date",
"Visit Type"
],
"items":{
"type":"string",
"description":"Column headers for the data grid.",
"example":"[\"Subject Id\",\"Visit Date\",\"Visit Type\"]"
}
},
"headers":{
"type":"object",
"additionalProperties":{
"type":"object",
"description":"Additional metadata headers for this report section, such as site info or investigator.",
"example":{
"siteNumbr":"S01",
"investigator":"Dr. Smith",
"shipmentNumbr":"123ABCXYZ"
}
},
"description":"Additional metadata headers for this report section, such as site info or investigator.",
"example":{
"siteNumbr":"S01",
"investigator":"Dr. Smith",
"shipmentNumbr":"123ABCXYZ"
}
}
}
},
"ExtFieldSpecs":{
"type":"object",
"properties":{
"fieldSpecsList":{
"required":[
"fieldName",
"fieldType",
"fieldValueList"
],
"type":"object",
"properties":{
"fieldName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Field name to evaluate. Examples include STUDYID, SITEID, ruleState, and dateRange.",
"example":"ruleState"
},
"fieldType":{
"maxLength":16,
"minLength":4,
"type":"string",
"description":"Field value classification. Use list for enumerations, date for calendar values, date-time for timestamps, number for numeric filters, string for textual filters, or boolean for true/false.",
"example":"list",
"enum":[
"list",
"date",
"date-time",
"number",
"string",
"boolean"
]
},
"fieldSequence":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"Sequence/order of the field. Provide a non-negative integer.",
"format":"int32",
"example":1
},
"fieldValueList":{
"type":"array",
"description":"List of values for the Field. Provide GUIDs for identifier filters or literal values for textual filters.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"maxLength":256,
"minLength":1,
"type":"string",
"example":"publish"
}
}
},
"description":"Generic representation of a report filter. Each entry specifies the field to evaluate, its data type, and the values to use when filtering.",
"example":{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved"
]
}
},
"extFieldSpecsList":{
"required":[
"fieldName",
"fieldType",
"fieldValueList"
],
"type":"object",
"properties":{
"fieldName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Field name to evaluate. Examples include STUDYID, SITEID, ruleState, and dateRange.",
"example":"ruleState"
},
"fieldType":{
"maxLength":16,
"minLength":4,
"type":"string",
"description":"Field value classification. Use list for enumerations, date for calendar values, date-time for timestamps, number for numeric filters, string for textual filters, or boolean for true/false.",
"example":"list",
"enum":[
"list",
"date",
"date-time",
"number",
"string",
"boolean"
]
},
"fieldSequence":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"Sequence/order of the field. Provide a non-negative integer.",
"format":"int32",
"example":1
},
"fieldValueList":{
"type":"array",
"description":"List of values for the Field. Provide GUIDs for identifier filters or literal values for textual filters.",
"example":[
{
"id":"C36A3197FDEE433FB5547EE83DE99E4B"
}
],
"items":{
"maxLength":256,
"minLength":1,
"type":"string",
"example":"publish"
}
}
},
"description":"Generic representation of a report filter. Each entry specifies the field to evaluate, its data type, and the values to use when filtering.",
"example":{
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved"
]
}
}
},
"description":"Specifies fields for report generation"
},
"JobRequest":{
"type":"object",
"properties":{
"fieldSpecsList":{
"$ref":"#/components/schemas/ReportField"
},
"extFieldSpecsList":{
"$ref":"#/components/schemas/ReportField"
}
},
"description":"Job request payload for report generation, specifying lists of Field specifications.",
"example":{
"fieldSpecsList":[
{
"fldId":"546A77A696BE11EABB370242AC130002",
"fieldType":"list",
"fieldName":"fileName",
"fieldValueList":[
"Study Name_Form Name_Timestamp (CSV only)"
]
},
{
"fieldType":"list",
"fieldName":"siteId",
"fldId":"546A79C296BE11EABB370242AC130002",
"fieldValueList":[
"549AD8CA793C46688ECF6332C8926319"
]
}
],
"extFieldSpecsList":[
{
"fldId":"546A77A696BE11EABB370242AC130002",
"fieldName":"File Name",
"fieldType":"list",
"fieldValueList":[
"Study Name_Form Name_Timestamp (CSV only)"
]
},
{
"fldId":"546A79C296BE11EABB370242AC130002",
"fieldName":"Site",
"fieldType":"list",
"fieldValueList":[
"Site001 - Site002"
]
}
]
}
},
"ReportField":{
"required":[
"fieldId",
"fieldName",
"fieldType",
"fieldValueList"
],
"type":"object",
"properties":{
"fieldId":{
"maxLength":32,
"minLength":32,
"pattern":"^[0-9A-Fa-f]{32}$",
"type":"string",
"description":"Unique 32 character identifier for the report field definition.",
"example":"C62C9522D70F41FDBB57FC92B05D6D02"
},
"fieldName":{
"maxLength":255,
"minLength":1,
"type":"string",
"description":"Report field name being filtered. Examples include ruleState, ruleEnabled, siteIds, and dateRange.",
"example":"ruleState"
},
"fieldType":{
"maxLength":16,
"minLength":4,
"type":"string",
"description":"Data classification for the supplied field values. Use list for discrete enumerations, date for calendar values, date-time for timestamp ranges, number for numeric filters, or string for textual filters.",
"example":"list",
"enum":[
"list",
"date",
"date-time",
"number",
"string",
"boolean"
]
},
"fieldSequence":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"Zero-based order in which the field should be evaluated. Provide a non-negative integer.",
"format":"int32",
"example":1
},
"fieldValueList":{
"type":"array",
"description":"List of values used when filtering the report for this field. Supply GUIDs for identifier fields and literal values for other types.",
"items":{
"maxLength":256,
"minLength":1,
"type":"string",
"example":"approved"
}
}
},
"description":"Field metadata supplied when generating a Rule Designer report. Every entry identifies a report filter or column definition and provides the values to apply.",
"example":{
"fldId":"C62C9522D70F41FDBB57FC92B05D6D02",
"fieldName":"ruleState",
"fieldType":"list",
"fieldSequence":1,
"fieldValueList":[
"approved",
"publish"
]
}
},
"PaginatedReportRunStatus":{
"type":"object",
"properties":{
"hasMore":{
"type":"string",
"description":"If true, more results are available beyond this page.",
"example":"true"
},
"totalResults":{
"type":"integer",
"description":"Total number of report runs available.",
"format":"int32",
"example":200
},
"count":{
"type":"integer",
"description":"Number of report runs in this page.",
"format":"int32",
"example":50
},
"limit":{
"type":"integer",
"description":"Page size requested.",
"format":"int32",
"example":50
},
"offset":{
"type":"integer",
"description":"Page offset in result set.",
"format":"int32",
"example":0
},
"reportId":{
"type":"string",
"description":"Reporting template UUID corresponding to these runs.",
"format":"uuid"
},
"reportRunStatus":{
"type":"array",
"items":{
"$ref":"#/components/schemas/ReportRunStatus"
}
}
},
"description":"Reports a paginated list of executed report runs for a given reporting template."
},
"ReportRunStatus":{
"type":"object",
"properties":{
"rptKickoffDatetime":{
"type":"string",
"description":"Timestamp when report generation started (UTC).",
"format":"date-time",
"example":"2025-10-27T10:00:00Z"
},
"rptFormat":{
"type":"string",
"description":"File format for the report, e.g., PDF, XLSX.",
"example":"PDF"
},
"currSearchSpec":{
"type":"string",
"description":"Current search/filter specification string.",
"example":"siteId:SITE001"
},
"currSortSpec":{
"type":"string",
"description":"Current sort specification string.",
"example":"subjectId"
},
"downloadId":{
"type":"string",
"description":"Unique identifier for this download/run (UUID, upper-case hex).",
"format":"uuid"
},
"rptId":{
"type":"string",
"description":"Report ID for this run (UUID).",
"format":"uuid"
}
},
"description":"Execution status/details for a report run."
},
"FormStatusDto":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":0
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
}
},
"description":"Represents the status of a form for a given event and instance including outer repeat and event instance number."
},
"FormDetails":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
}
},
"description":"Represents filter criteria for a single form entry including event, form and event instance number",
"example":[
{
"eventId":"ADF5A7800A954FA5B831E7B6B9CA39A9",
"formId":"40DB4EF4847849CCB24EFCCB71CDA436",
"eventInstanceNum":1
}
]
},
"FormDetailsRequestDto":{
"type":"object",
"properties":{
"formDetails":{
"type":"array",
"description":"List of form details specifying event, form and instance filters",
"example":[
{
"eventId":"ADF5A7800A954FA5B831E7B6B9CA39A9",
"formId":"40DB4EF4847849CCB24EFCCB71CDA436",
"eventInstanceNum":1
}
],
"items":{
"$ref":"#/components/schemas/FormDetails"
}
}
},
"description":"Request DTO containing a list of form filters used to retrieve form status for a subject. Each entry specifies eventId, formId and optionally eventInstanceNum."
},
"LockedStatusDTO":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-01T10:00:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"225B79C982104415886DE02BC73C1E1E"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":300
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason provided for the lock or action.",
"example":"Site audit lock"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment or note about the action.",
"example":"Locked by monitor for review"
},
"siteID":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"938D23FA6B7241CCA41BD627E5DB60DA"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"A1B2C3D4E5F647839ABCDEF012345678"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D4E5F6A1B2C347839ABCDEF012345678"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Internal repeat sequence number for item or visit repeats.",
"format":"int",
"example":0
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"0F1E2D3C4B5A69788796A5B4C3D2E1F0"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF12ABCDEF12ABCDEF12ABCDEF12"
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int",
"example":0
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int",
"example":0
},
"action":{
"type":"string",
"description":"Action taken on the visit start date value.Acceptable values are LOCKED, UNLOCKED, NEVER_LOCKED.",
"example":"LOCKED"
},
"visitStartDateAction":{
"type":"string",
"description":"Action to be taken for the visit. The value may be SCREEN_ENABLE, SCREEN_DISABLE, RANDOMIZE_ENABLE, RANDOMIZE_DISABLE, DISPENSE_ENABLE, DISPENSE_DISABLE, COMPLETE_STUDY_ENABLE and COMPLETE_STUDY_DISABLE.",
"example":"COMPLETE_STUDY_DISABLE"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int",
"example":1
}
}
},
"SubjectLockRequestDTO":{
"title":"SubjectLockRequestDTO",
"required":[
"subjects"
],
"type":"object",
"properties":{
"subjects":{
"maxItems":2147483647,
"minItems":1,
"type":"array",
"description":"List of subject identifiers in UUID, 32-character uppercase hexadecimal string",
"example":[
"1BC29B36F5D64B1B95F4BDBBCEA481BE",
"2ABC8A2C11045A584ADEA8760F72B114"
],
"items":{
"type":"string",
"description":"List of subject identifiers in UUID, 32-character uppercase hexadecimal string",
"format":"uuid"
}
}
},
"description":"Contains a list of subjects to get lock status details"
},
"FieldSet":{
"required":[
"fieldType"
],
"type":"object",
"properties":{
"fieldName":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Name of the field.",
"example":"studyVersion"
},
"fieldType":{
"maxLength":50,
"minLength":0,
"type":"string",
"description":"Type of the field.",
"example":"list"
},
"fieldSequence":{
"minimum":0,
"type":"integer",
"description":"Sequence/order of the field.",
"format":"int32",
"example":1
},
"fieldValueList":{
"type":"array",
"description":"List of values used for filtering the field",
"example":"[1.0.0.1]",
"items":{
"type":"string",
"description":"List of values used for filtering the field",
"example":"[1.0.0.1]"
}
},
"fieldNameList":{
"type":"array",
"description":"List of field names when specifying multiple fields together",
"example":[
"dataElementId",
"versionStart"
],
"items":{
"type":"string",
"description":"List of field names when specifying multiple fields together",
"example":"[\"dataElementId\",\"versionStart\"]"
}
},
"fieldValueSets":{
"type":"array",
"description":"List of value sets corresponding to fieldNameList order. Each inner list contains values or operators as applicable.",
"example":[
[
"299BC76CF0F943E6BAC1D209BC3D1CDC",
"2018-11-21 11:45:31.854"
]
],
"items":{
"type":"array",
"description":"List of value sets corresponding to fieldNameList order. Each inner list contains values or operators as applicable.",
"example":[
[
"299BC76CF0F943E6BAC1D209BC3D1CDC",
"2018-11-21 11:45:31.854"
]
],
"items":{
"type":"object",
"description":"List of value sets corresponding to fieldNameList order. Each inner list contains values or operators as applicable.",
"example":[
[
"299BC76CF0F943E6BAC1D209BC3D1CDC",
"2018-11-21 11:45:31.854"
]
]
}
}
}
},
"description":"Defines a search field and optional lists of values for reporting queries.",
"example":[
{
"fieldName":"VisitName",
"fieldType":"STRING",
"fieldSequence":1,
"fieldValueList":[
"SCREENED",
"ENROLLED"
]
}
]
},
"SearchSpecsSet":{
"type":"object",
"properties":{
"limit":{
"maximum":10000,
"minimum":1,
"type":"integer",
"description":"Maximum number of records to display per page.",
"format":"int32",
"example":10000
},
"offset":{
"maximum":2147483647,
"minimum":0,
"type":"integer",
"description":"An order number to specify with which object you want to start retrieving result. If provided, you also need to specify a value for the limit parameter.",
"format":"int32",
"example":0
},
"fieldSpecsList":{
"type":"array",
"description":"List of field specifications used to filter or select data",
"example":[
{
"fieldName":"VisitName",
"fieldType":"STRING",
"fieldSequence":1,
"fieldValueList":[
"SCREENED",
"ENROLLED"
]
}
],
"items":{
"$ref":"#/components/schemas/FieldSet"
}
}
},
"description":"Search specification wrapper including pagination and a list of field filters for reporting queries."
},
"SignEligibilityDTO":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the eligibility history record",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-02T09:00:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":1
},
"reason":{
"type":"string",
"description":"Reason for eligibility determination",
"example":"All inclusion and no exclusion criteria met"
},
"comment":{
"type":"string",
"description":"Free-form comment providing additional context",
"example":"Eligibility approved by investigator"
},
"configId":{
"type":"string",
"description":"Signature configuration identifier (UUID, 32-character uppercase hexadecimal string).",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"startEligibibleDate":{
"type":"string",
"description":"Date from which subject becomes eligible",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"requiredOn":{
"type":"string",
"description":"Entity on which signature is required Example - SUBJECT/FORM/CASEBOOK)",
"example":"SUBJECT"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int64",
"example":1
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":0
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int64",
"example":0
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":0
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2A5E92F1C2D54DDA9F1C0A9E7B3C2D1A"
},
"status":{
"type":"string",
"description":"Eligibility status.Values can be SIGNED,UNSIGNED or NEVER_SIGNED.",
"example":"NEVER_SIGNED"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"1.0.0.3"
}
},
"description":"Eligibility history record capturing audit metadata, target objects and status within a specific study version."
},
"SubjectVisitVerifyHistoryDto2":{
"type":"object",
"properties":{
"subjectId":{
"type":"string",
"description":"Subject identifier",
"example":"93CC828113AC439181071CB44D2C6FE5"
},
"eventId":{
"type":"string",
"description":"Study event identifier",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"verifyStatus":{
"type":"string",
"description":"Verification status of the subject's visit, Example values can be SIGNED, VERIFIED, UNSIGNED, UNVERIFIED, NEVER_SIGNED, NEVER_VERIFIED, VERIFY_REQUIRED, NOT_APPLICABLE, FROZEN, UNFROZEN, NEVER_FROZEN, PARTIAL_SIGNED",
"example":"VERIFIED"
},
"eventInstanceNum":{
"type":"integer",
"description":"Instance number of the event",
"format":"int64",
"example":1
},
"versionSatrt":{
"type":"string",
"description":"Start of version validity window (inclusive)",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"End of version validity window (exclusive, if present)",
"format":"date-time",
"example":"2023-01-31T09:00:00Z"
},
"studyVersion":{
"type":"string",
"description":"Study version string",
"example":"3.0.0.1"
},
"siteId":{
"type":"string",
"description":"Site identifier where the visit verification occurred",
"example":"SITE001"
}
},
"description":"Visit verification history for a subject and event including version window, siteId and study version."
},
"SignVerifyFreezeDTOv40":{
"type":"object",
"properties":{
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"0C50E26E482246B2BB9646C739E97CAA"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the Sign/Verify/Freeze record in UUID format",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-02T17:30:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"2C3F40649C654D0F995A7FDBBCEA4FAB"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":100
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"reason to make this change",
"example":"Other"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comments if provided",
"example":"Data discrepancy observed and clarified"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"7978B7DD0A0A4CA899C485990994300C"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"C39E34A9152148E0BB831239BAA3E502"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"AF77C6450BE94DE293C9630142E0AFAD"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int64",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"example":"33CAF3CB1DF64DF5A353A337CBE6B50A"
},
"signed":{
"type":"string",
"description":"Signed status can be of SIGNED, UNSIGNED, NEVER_SIGNED, PARTIAL_SIGNED ",
"example":"2C3F40649C654D0F995A7FDBBCEA4FAB"
},
"verify":{
"type":"string",
"description":"Verify status can be UNVERIFIED, VERIFIED, NEVER_VERIFIED, VERIFY_REQUIRED",
"example":"VERIFIED"
},
"freeze":{
"type":"string",
"description":"Freeze status can be of FROZEN, UNFROZEN, NEVER_FROZEN",
"example":"FROZEN"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"2.0.0.38"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":3
},
"repeatFormNumber":{
"type":"integer",
"description":"Represents the ordinal number assigned to a repeated instance of a data collection form. It uniquely identifies each occurrence of a repeating form for a subject when multiple instances of the form.",
"format":"int64",
"example":0
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int64",
"example":0
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int64",
"example":0
}
}
},
"SDVGroupInfoDTOv20":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) for the SDV group info record.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-06-01T09:00:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"9F86D081884C7D659A2FEAA0C55AD015"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":30
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Initial SDV strategy creation"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Configured for screening visits"
},
"attributeValue":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Value for a configurable attribute associated with this SDV group. The acceptable values are - All Questions, Critical Questions Only or it can be a number like 30.",
"example":"50"
},
"attributeKey":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Key for a configurable attribute associated with this SDV group. Values may be REMAINING_SUBJECTS_PERCENTAGE, REMAINING_SUBJECTS_SDV_TYPE, INITIAL_SUBJECTS_SDV_TYPE, INITIAL_SUBJECTS_COUNT.",
"example":"INITIAL_SUBJECTS_COUNT"
},
"sdvGroupName":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Human readable name of the SDV group.",
"example":"Screening Group"
},
"sdvGroupId":{
"type":"string",
"description":"ID of the Source Data Verification (SDV) group. The format is UUID, 32-character uppercase hexadecimal string.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
},
"description":"Represents Source Data Verification (SDV) group information including audit and versioning details."
},
"SubjectsVisitScheduleDto70":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectRespDto13"
},
"visits":{
"type":"array",
"description":"Status entries of visits for the subject",
"items":{
"$ref":"#/components/schemas/VisitsStatusDto12"
}
},
"scheduledVisits":{
"type":"array",
"description":"Scheduled visits derived for the subject",
"items":{
"$ref":"#/components/schemas/ScheduledVisitsDto20"
}
},
"crntStateStudyVrsn":{
"type":"string",
"description":"Current state study version in which the subject resides",
"example":"3.0.0.1"
}
},
"description":"Subject with visit status and scheduled visit information for a specific study version"
},
"SubjectNumberTransferDto":{
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the subject number transfer record.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"42CE52A1AF9A48EBABA25A361F6EC0FE"
},
"subjectNumber":{
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"newSubjectNumber":{
"type":"string",
"description":"New subject number after transfer or renumbering.",
"example":"SUBJ-0001-NEW"
},
"fromSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred from.",
"example":"938D23FA6B7241CCA41BD627E5DB60DA"
},
"toSiteId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the clinical site the subject is transferred to.",
"example":"699EF3745FC545589F186D2198F3C65E"
},
"reason":{
"type":"string",
"description":"Reason for the subject number transfer.",
"example":"Site change"
},
"comment":{
"type":"string",
"description":"Additional comment or note about the transfer.",
"example":"Automated renumber after transfer"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
},
"softwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":300
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2023-01-01T09:00:00Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"format":"date-time",
"example":"2023-01-01T10:00:00Z"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"225B79C982104415886DE02BC73C1E1E"
},
"randNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"R-000123"
}
}
},
"RestResponseSubjectVisitsStatusResponse70":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse70"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"VisitsStatusDto10":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the record",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"Start timestamp of the version record",
"example":"2025-10-16T14:30:31.892Z"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"visitStatus":{
"type":"string",
"description":"Status of the visit. The Value of the status can be NEW, COMPLETE, COMPLETE_ERR, INPROGRESS, INCOMPLETE, INCOMPLETE_ERR, SKIPPED, UNDO_SKIP and NOT_STARTED.",
"example":"COMPLETE"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the visit status",
"example":"Subject completed the visit successfully"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Additional comment for the visit status",
"example":"All data verified"
},
"visitStartDate":{
"type":"string",
"description":"Visit start date timestamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"visitType":{
"type":"string",
"description":"Type of visit as per the visit type enumeration. The acceptable values are: SCREENING, RANDOMIZATION, DISPENSATION, NON_DISPENSATION, OPTIONAL, OPTIONAL_DISPENSATION, WITHDRAW, SCREENDISP, SCREENRAND, SUBJECT_COMPLETE, UNSCHEDULED, UNSCHEDULED_DISPENSATION, ADVERSE_EVENT, SCREENFAILURE, RESCREENING and RESCREENDISP.",
"example":"SCREENING"
},
"eventType":{
"type":"string",
"description":"Event type corresponding to the visit. The acceptable values are: Visit_Not_Started, Visit_Started, Visit_Complete, Visit_Skipped, Visit_Skip_Undone, Visit_Date_Changed, Visit_Inserted, Visit_Show, Visit_Hide, VisitDateEntered and VisitDateCleared.",
"example":"Visit_Not_Started"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"repeatingFormCount":{
"type":"number",
"description":"Number of repeating form instances for the visit.",
"example":2
},
"scheduledWindowStartDate":{
"type":"string",
"description":"Scheduled window start date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"scheduledWindowEndDate":{
"type":"string",
"description":"Scheduled window end date for the visit",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"associatedStudyVersion":{
"type":"string",
"description":"Study version with which the visit status is associated",
"example":"3.0.0.1"
},
"display":{
"type":"string",
"description":"Display label of the visit status",
"example":"Baseline Visit"
},
"leadingDataelementId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the leading data element for the visit.",
"example":"93CC828113AC439181071CB44D2C6FE5"
}
},
"description":"Visit status with display text and leading data element identifier for UI rendering"
},
"DataElementDtoV60":{
"required":[
"studyVersion"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the data element",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionStart":{
"type":"string",
"description":"The date and time at which the transaction processing began.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"transactionEnd":{
"type":"string",
"description":"The date and time at which the transaction processing completed.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"validationStatus":{
"maxLength":25,
"minLength":0,
"type":"string",
"description":"Validation status of the data element. The validation status can be null or SUCCESS.",
"example":"SUCCESS"
},
"validationFailure":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Validation failure details if any",
"example":"Incorrect values not allowed"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"studyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Study name",
"example":"STUDY-ABC"
},
"studyVersion":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"subjectId":{
"type":"string",
"description":"Unique identifier of the subject. Used to represent a participant enrolled in a study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"10F75668189F422F9A461A315D211111"
},
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"format":"UUID",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"formSectionId":{
"type":"string",
"description":"Unique identifier of the table within a two section form or lab form. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"B6E0C7D5A1F3428C8B8B6A77C5E9D4AA"
},
"repeatSequenceNumber":{
"type":"integer",
"description":"Indicates the order of occurrence for a repeating form instance, used to distinguish between multiple repetitions of the same form.",
"format":"int32",
"example":1
},
"itemId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the question within a form. This ID corresponds to the reference code set by the study designer when creating or updating a form question in draft mode.",
"format":"UUID",
"example":"DEADBEEFDEADBEEFDEADBEEFDEADBEEF"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"format":"UUID",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"variableId":{
"type":"string",
"description":"Variable identifier (UUID, 32-character uppercase hexadecimal string) in uppercase hex format.",
"format":"UUID",
"example":"0123456789ABCDEF0123456789ABCDEF"
},
"originatorId":{
"type":"string",
"description":"An identifier representing the system, or user that initiated the transaction (UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"FEDCBA9876543210FEDCBA9876543210"
},
"vendorCode":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Vendor code if provided",
"example":"VENDOR1"
},
"value":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Raw value captured for the item",
"example":"120"
},
"measureUnit":{
"maxLength":64,
"minLength":0,
"type":"string",
"description":"Measurement unit",
"example":"mg/dL"
},
"normalizedValue":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Normalized value if applicable",
"example":"120"
},
"normalizedUnitId":{
"type":"string",
"description":"Identifier of normalized unit",
"example":"A78AD8C31CD843CD8B847C06C0420FF5"
},
"numValue":{
"type":"integer",
"description":"Numeric integer value",
"format":"int32",
"example":120
},
"floatValue":{
"type":"number",
"description":"Numeric decimal value",
"format":"decimal",
"example":12.34
},
"dateTimeValueUTC":{
"type":"string",
"description":"Date-time value in UTC",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"monthValue":{
"type":"integer",
"description":"Month part of date",
"format":"int32",
"example":10
},
"dayValue":{
"type":"integer",
"description":"Day part of date",
"format":"int32",
"example":16
},
"yearValue":{
"type":"integer",
"description":"Year part of date",
"format":"int32",
"example":2025
},
"hourValue":{
"type":"integer",
"description":"Hour part of time",
"format":"int32",
"example":14
},
"minuteValue":{
"type":"integer",
"description":"Minute part of time",
"format":"int32",
"example":30
},
"secondValue":{
"type":"integer",
"description":"Second part of time",
"format":"int32",
"example":31
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason associated with the data element change",
"example":"Initial entry"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for the data element change",
"example":"Captured by device"
},
"operationType":{
"type":"string"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"dataFlag":{
"type":"string",
"description":"Unique Data flag identifier(UUID, 32-character uppercase hexadecimal string).",
"format":"UUID",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
}
}
},
"FormStatusDto2":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"outerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of the primary or outer repeating form. This value identifies each top-level occurrence of a repeating form and serves as the parent context for any nested inner repeats.",
"format":"int32",
"example":0
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"formStatus":{
"type":"string",
"description":"Status of the form. Status can be NEW, OPTIONAL, COMPLETED, COMPLETED_WITH_ERROR, IN_PROGRESS, IN_PROGRESS_WITH_ERROR, INCOMPLETE, INCOMPLETE_WITH_ERROR or DELETED.",
"example":"COMPLETED"
},
"innerRepeat":{
"type":"integer",
"description":"Indicates the repeat sequence number of a nested or inner repeating form within an outer repeating structure. This value is used to distinguish multiple occurrences of the same inner form for a given outer repeat instance.",
"format":"int32",
"example":0
},
"formStart3":{
"type":"string",
"description":"Form start timestamp based on latest computation in this version.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"formCompletion3":{
"type":"string",
"description":"Form completion timestamp based on latest computation in this version.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"formLastUpdate3":{
"type":"string",
"description":"Form last update timestamp based on latest computation in this version.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"formStart":{
"type":"string",
"description":"Form start timestamp.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"formCompletion":{
"type":"string",
"description":"Form completion timestamp.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"formLastUpdate":{
"type":"string",
"description":"Form last update timestamp.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Extends FormStatusDto with inner repeat and timestamps for form start, completion and last update. All timestamps are in UTC."
},
"FormDetails2":{
"type":"object",
"properties":{
"eventId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) of the clinical event. A clinical event can be, for example: Screening, Randomization, Visit 1, etc. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ADF5A7800A954FA5B831E7B6B9CA39A9"
},
"formId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) representing the clinical form.",
"example":"40DB4EF4847849CCB24EFCCB71CDA436"
},
"eventInstanceNum":{
"type":"integer",
"description":"Numeric value representing the instance number of the event. Used for repeated or unscheduled visits (e.g., 1, 2, 3). It is null for scheduled events.",
"format":"int32",
"example":1
},
"usePersistence":{
"type":"boolean",
"description":"Indicates whether persisted cached values should be used when computing status, by default the flag is false",
"example":false
}
},
"description":"Represents filter criteria for a single form entry including event, form, event instance number and persistence usage flag."
},
"FormDetailsRequestDto2":{
"type":"object",
"properties":{
"formDetails":{
"type":"array",
"description":"List of form entries for which status is requested.",
"items":{
"$ref":"#/components/schemas/FormDetails2"
}
}
},
"description":"Contains a list of form entries used to request form status for a subject."
},
"SubjectDto110":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject",
"example":"RND-001"
}
}
},
"SubjectDto101":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject if applicable.",
"example":"RND-001"
}
}
},
"RestResponseSubjectVisitsStatusResponse90":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"$ref":"#/components/schemas/SubjectVisitsStatusResponse90"
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"SubjectDto30":{
"required":[
"state",
"studyVersion",
"subjectNumber"
],
"type":"object",
"properties":{
"screeningDate":{
"type":"string",
"description":"Screening date if applicable",
"format":"date-time",
"example":"2025-10-01T10:00:00Z"
},
"eventType":{
"type":"string",
"description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
"example":"Screened"
},
"subjectTransferId":{
"type":"string",
"description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":14
},
"mhealthSubjectId":{
"type":"string",
"description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"fromStudyId":{
"type":"string",
"description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"subjNumSiteOrgId":{
"type":"string",
"description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
"example":"5D5F9311C591424F852B99FD902E98A4"
},
"signedStatus":{
"type":"string",
"description":"Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
"example":"SIGNED"
},
"verifiedStatus":{
"type":"string",
"description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
"example":"VERIFIED"
},
"freezedStatus":{
"type":"string",
"description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
"example":"FROZEN"
},
"lastSigned":{
"type":"string",
"description":"Timestamp when the subject was last signed",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number associated with the event",
"example":14
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"subjectStudySerialNumber":{
"type":"string",
"description":"Study-level serial number assigned to the subject",
"example":"STUDY-0001-001"
},
"subjectSiteSerialNumber":{
"type":"string",
"description":"Site-level serial number assigned to the subject",
"example":"SITE-0001-001"
},
"versionEnd":{
"type":"string",
"description":"End timestamp of the subject version record",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"previousSubjectNumber":{
"type":"string",
"description":"Previous subject number if renumbered or transferred",
"example":"SUBJECT-0001-OLD"
},
"screenFailureDate":{
"type":"string",
"description":"Date when the subject was marked as screen failure",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"description":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Free text description for the subject",
"example":"Screened subject"
},
"subjectNumber":{
"maxLength":500,
"minLength":0,
"type":"string",
"description":"Unique subject Number representing the patient/participant enrolled in the study.",
"example":"SUBJ-0001"
},
"studyId":{
"type":"string",
"description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"siteId":{
"type":"string",
"description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"ABCDEF1234567890ABCDEF1234567890"
},
"dob":{
"type":"string",
"description":"Date of birth",
"format":"date-time"
},
"state":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include: - New
- Active
- Screening_Initiated
- Screen_Failed
- Withdrawn
- Auto_Screen_Failed
- Complete
- Enrolled
",
"example":"Active"
},
"stateDate":{
"type":"string",
"description":"Timestamp when the subject transitioned to current state",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"screeningFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for screening failure, if any",
"example":"Inclusion criteria not met"
},
"enrollmentFailure":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for enrollment failure, if any",
"example":"Consent withdrawn"
},
"enrollmentOverride":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"If subject enrollment is overridden.",
"example":"Subject Enrollment Overridden"
},
"informedConsentDate":{
"type":"string",
"description":"Informed consent date",
"format":"date-time",
"example":"2025-09-25T09:00:00Z"
},
"gender":{
"maxLength":10,
"minLength":0,
"type":"string",
"description":"Gender value",
"example":"[{\"value\":\"1\",\"label\":\"male\"}]"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason for latest subject update",
"example":"Protocol break happened"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment for latest subject update",
"example":"Initial enrollment"
},
"studyVersion":{
"type":"string",
"description":"String representing the version of the study. Helps track changes in form or study design.",
"example":"3.0.0.1"
},
"sourceTimeStamp":{
"type":"string",
"description":"Source system timestamp for the subject payload",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
},
"randomizationNumber":{
"type":"string",
"description":"Randomization number assigned to the subject",
"example":"RND-001"
},
"screeningNumber":{
"type":"string",
"description":"Screening number assigned to the subject",
"example":"SCR-0001"
}
}
},
"RestResponseListSubjectRespDto15":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectRespDto15"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"RestResponseListSubjectRespDto16":{
"type":"object",
"properties":{
"status":{
"type":"string"
},
"result":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectRespDto16"
}
},
"version":{
"type":"integer",
"format":"int32",
"writeOnly":true
},
"errorData":{
"$ref":"#/components/schemas/ErrorResponseData"
}
}
},
"Error Response":{
"type":"object",
"properties":{
"errorCode":{
"type":"string",
"description":"Application-specific error code representing the failure reason.",
"readOnly":true,
"example":"VALIDATION_ERROR"
},
"errorMessage":{
"type":"string",
"description":"Human-readable message describing the error.",
"readOnly":true,
"example":"Request payload validation failed"
},
"details":{
"type":"object",
"description":"Optional additional details about the error for diagnostics.",
"nullable":true,
"readOnly":true
}
},
"description":"Standard error body containing code, message and optional details.",
"nullable":true,
"readOnly":true
},
"NotificationResponse":{
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Status of the request processing. SUCCESS indicates the request was processed without errors. Any other value indicates failure.",
"readOnly":true,
"example":"success",
"enum":[
"success, Failed"
]
},
"result":{
"type":"object",
"description":"Result payload for the request. The concrete type depends on the endpoint and is described in the corresponding API documentation.",
"readOnly":true
},
"errorData":{
"$ref":"#/components/schemas/Error Response"
}
},
"description":"Standard wrapper for API responses. Contains the request processing status, the result payload for successful requests, and error details when a request fails."
},
"EmailTemplateDto1":{
"required":[
"subject"
],
"type":"object",
"properties":{
"subject":{
"type":"string",
"description":"Email subject line to use when sending the template",
"example":"Training Status Reminder"
},
"users":{
"type":"array",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":[
"C5770247BEF54CE0923B7C7CA3B659C8",
"DBF0480DD86446CE8482BE016726393C"
],
"items":{
"type":"string",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":"[\"C5770247BEF54CE0923B7C7CA3B659C8\",\"DBF0480DD86446CE8482BE016726393C\"]"
}
},
"placeHolderValueMap":{
"type":"object",
"description":"Map of placeholder variables to be replaced in the template body",
"example":{
"userTrainingDetails":" ",
"redirectUrl":"",
"username":"system",
"studyName":"AutomationStudy"
}
},
"placeHolderImageMap":{
"type":"object",
"description":"Map of placeholder image variables to URLs or resource identifiers",
"example":{
"image5":"NOTIFICATION.EMAIL.IMAGE5",
"image3":"NOTIFICATION.EMAIL.IMAGE3",
"image4":"NOTIFICATION.EMAIL.IMAGE4",
"image1":"NOTIFICATION.EMAIL.IMAGE1",
"image2":"NOTIFICATION.EMAIL.IMAGE2"
}
}
},
"description":"Request body for sending an email based on a predefined template. Includes subject override, recipient users, and placeholder maps for text and images."
},
"EmailTemplateDto2":{
"required":[
"subject"
],
"type":"object",
"properties":{
"subject":{
"type":"string",
"description":"Email subject line to use when sending the template",
"example":"Training Status Reminder"
},
"users":{
"type":"array",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":[
"C5770247BEF54CE0923B7C7CA3B659C8",
"DBF0480DD86446CE8482BE016726393C"
],
"items":{
"type":"string",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":"[\"C5770247BEF54CE0923B7C7CA3B659C8\",\"DBF0480DD86446CE8482BE016726393C\"]"
}
},
"placeHolderValueMap":{
"type":"object",
"description":"Map of placeholder variables to be replaced in the template body",
"example":{
"userTrainingDetails":" ",
"redirectUrl":"",
"username":"system",
"studyName":"AutomationStudy"
}
},
"placeHolderImageMap":{
"type":"object",
"description":"Map of placeholder image variables to URLs or resource identifiers",
"example":{
"image5":"NOTIFICATION.EMAIL.IMAGE5",
"image3":"NOTIFICATION.EMAIL.IMAGE3",
"image4":"NOTIFICATION.EMAIL.IMAGE4",
"image1":"NOTIFICATION.EMAIL.IMAGE1",
"image2":"NOTIFICATION.EMAIL.IMAGE2"
}
},
"emailAddresses":{
"type":"array",
"description":"Additional recipient email addresses not associated with users",
"example":[
"john.doe@oracle.com"
],
"items":{
"type":"string",
"description":"Additional recipient email addresses not associated with users",
"example":"[\"john.doe@oracle.com\"]"
}
}
},
"description":"Request body for sending an email based on a predefined template by allowing direct recipient email addresses in addition to users and placeholder maps."
},
"EmailTemplateDto3":{
"required":[
"subject"
],
"type":"object",
"properties":{
"subject":{
"type":"string",
"description":"Email subject line to use when sending the template",
"example":"Training Status Reminder"
},
"users":{
"type":"array",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":[
"C5770247BEF54CE0923B7C7CA3B659C8",
"DBF0480DD86446CE8482BE016726393C"
],
"items":{
"type":"string",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":"[\"C5770247BEF54CE0923B7C7CA3B659C8\",\"DBF0480DD86446CE8482BE016726393C\"]"
}
},
"placeHolderValueMap":{
"type":"object",
"description":"Map of placeholder variables to be replaced in the template body",
"example":{
"userTrainingDetails":" ",
"redirectUrl":"",
"username":"system",
"studyName":"AutomationStudy"
}
},
"placeHolderImageMap":{
"type":"object",
"description":"Map of placeholder image variables to URLs or resource identifiers",
"example":{
"image5":"NOTIFICATION.EMAIL.IMAGE5",
"image3":"NOTIFICATION.EMAIL.IMAGE3",
"image4":"NOTIFICATION.EMAIL.IMAGE4",
"image1":"NOTIFICATION.EMAIL.IMAGE1",
"image2":"NOTIFICATION.EMAIL.IMAGE2"
}
},
"emailAddresses":{
"type":"array",
"description":"Additional recipient email addresses not associated with users",
"example":[
"john.doe@oracle.com"
],
"items":{
"type":"string",
"description":"Additional recipient email addresses not associated with users",
"example":"[\"john.doe@oracle.com\"]"
}
},
"studyRoleIds":{
"type":"array",
"description":"List of study role identifiers to target (UUID, 32-character uppercase hexadecimal string)",
"example":[
"1BC29B36F5D64B1B95F4BD32CEA481BE",
"8F14E45FC1EA167A5A36D5DD4BEA2543"
],
"items":{
"type":"string",
"description":"List of study role identifiers to target (UUID, 32-character uppercase hexadecimal string)",
"example":"[\"1BC29B36F5D64B1B95F4BD32CEA481BE\",\"8F14E45FC1EA167A5A36D5DD4BEA2543\"]"
}
}
},
"description":"Supporting study role based targeting in addition to direct email addresses and users."
},
"EmailTemplateDto4":{
"required":[
"subject"
],
"type":"object",
"properties":{
"subject":{
"type":"string",
"description":"Email subject line to use when sending the template",
"example":"Training Status Reminder"
},
"users":{
"type":"array",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":[
"C5770247BEF54CE0923B7C7CA3B659C8",
"DBF0480DD86446CE8482BE016726393C"
],
"items":{
"type":"string",
"description":"List of recipient user identifiers (UUID, 32-character uppercase hexadecimal string)",
"example":"[\"C5770247BEF54CE0923B7C7CA3B659C8\",\"DBF0480DD86446CE8482BE016726393C\"]"
}
},
"placeHolderValueMap":{
"type":"object",
"description":"Map of placeholder variables to be replaced in the template body",
"example":{
"userTrainingDetails":" ",
"redirectUrl":"",
"username":"system",
"studyName":"AutomationStudy"
}
},
"placeHolderImageMap":{
"type":"object",
"description":"Map of placeholder image variables to URLs or resource identifiers",
"example":{
"image5":"NOTIFICATION.EMAIL.IMAGE5",
"image3":"NOTIFICATION.EMAIL.IMAGE3",
"image4":"NOTIFICATION.EMAIL.IMAGE4",
"image1":"NOTIFICATION.EMAIL.IMAGE1",
"image2":"NOTIFICATION.EMAIL.IMAGE2"
}
},
"emailAddresses":{
"type":"array",
"description":"Additional recipient email addresses not associated with users",
"example":[
"john.doe@oracle.com"
],
"items":{
"type":"string",
"description":"Additional recipient email addresses not associated with users",
"example":"[\"john.doe@oracle.com\"]"
}
},
"studyRoleIds":{
"type":"array",
"description":"List of study role identifiers to target (UUID, 32-character uppercase hexadecimal string)",
"example":[
"1BC29B36F5D64B1B95F4BD32CEA481BE",
"8F14E45FC1EA167A5A36D5DD4BEA2543"
],
"items":{
"type":"string",
"description":"List of study role identifiers to target (UUID, 32-character uppercase hexadecimal string)",
"example":"[\"1BC29B36F5D64B1B95F4BD32CEA481BE\",\"8F14E45FC1EA167A5A36D5DD4BEA2543\"]"
}
},
"siteId":{
"type":"string",
"description":"Unique Identifier of the site (UUID, 32-character uppercase hexadecimal string)",
"example":"97EF9A19358D4EEC9224429DD6053609"
}
},
"description":"Adding the site identifier to further scope notifications broadcasts."
},
"AnchorValues":{
"type":"object",
"properties":{
"keyValues":{
"type":"array",
"description":"List of key-value entries used to substitute placeholders for this anchor",
"items":{
"$ref":"#/components/schemas/KeyValues"
}
}
},
"description":"Container for key-value parameters that provide substitution values for a given anchor key."
},
"Anchors":{
"type":"object",
"properties":{
"anchorKey":{
"type":"string",
"description":"Unique subject anchor key within the export payload. Some examples: NTF_ORS_DEPOT_LOW_KIT, NTF_ORS_BODY_STUDY_NAME, NTF_ORS_BODY_STUDY_ID, NTF_ORS_BODY_STUDY_MODE, NTF_ORS_MODE_ACTIVE, NTF_ORS_MODE_TEST, NTF_ORS_MODE_TRAINING, NTF_ORS_NEW_SHIPMENT_DEPOT_ID, NTF_ORS_NEW_SHIPMENT_DEPOT_NAME, NTF_ORS_DEPOT_ADDRESS, NTF_ORS_DATE_ALERT_RAISED, NTF_ORS_KIT_TYPE_ID, NTF_ORS_KIT_TYPE_DESCRIPTION, NTF_ORS_CURRENT_INVENTORY_AVAILABLE.",
"example":"NTF_SIGN_OVERDUE"
},
"anchorValues":{
"$ref":"#/components/schemas/AnchorValues"
}
},
"description":"Anchor mapping used within template properties for text substitution. Associates an anchor key with its parameter values."
},
"EmailTemplateNotificationDto":{
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/Subject"
},
"users":{
"type":"array",
"description":"List of recipient user email addresses",
"example":[
"C5770247BEF54CE0923B7C7CA3B659C8",
"DBF0480DD86446CE8482BE016726393C"
],
"items":{
"type":"string",
"description":"List of recipient user email addresses",
"example":"[\"C5770247BEF54CE0923B7C7CA3B659C8\",\"DBF0480DD86446CE8482BE016726393C\"]"
}
},
"placeHolderValueMap":{
"$ref":"#/components/schemas/PlaceHolderValueMap"
},
"placeHolderImageMap":{
"type":"object",
"description":"Placeholder images map used by the template, mapping keys to image URLs or identifiers",
"example":{
"logo":"https://cdn.example.com/assets/logo.png"
}
},
"emailAddresses":{
"type":"array",
"description":"Additional direct recipient email addresses",
"example":[
"user.surname@email.com"
],
"items":{
"type":"string",
"description":"Additional direct recipient email addresses",
"example":"[\"user.surname@email.com\"]"
}
},
"studyRoleIds":{
"type":"array",
"description":"List of study role identifiers to target",
"example":[
"1BC29B36F5D64B1B95F4BD765EA481BE"
],
"items":{
"type":"string",
"description":"List of study role identifiers to target",
"example":"[\"1BC29B36F5D64B1B95F4BD765EA481BE\"]"
}
}
},
"description":"Request body for sending localized email based on template with subject structure, recipients, placeholder maps, and optional direct email addresses and study role IDs."
},
"KeyValues":{
"type":"object",
"properties":{
"key":{
"type":"integer",
"description":"Integer key representing the position or identifier of the parameter in the anchor.",
"format":"int32",
"example":0
},
"value":{
"type":"string",
"description":"Parameter value to substitute.",
"example":"ACTIVE"
},
"type":{
"type":"string",
"description":"Type of the value for rendering or validation. Typical values: TEXT, DATE.",
"example":"TEXT"
}
},
"description":"Represents a single parameter for anchor substitution with an integer key, a value, and a type describing how to interpret the value."
},
"PlaceHolderValueMap":{
"type":"object",
"properties":{
"properties":{
"type":"array",
"description":"List of placeholder properties to substitute within the template body.",
"items":{
"$ref":"#/components/schemas/Properties"
}
}
},
"description":"Container for placeholder properties used to build localized email content. Each property may define anchors for parameterized substitution."
},
"Properties":{
"type":"object",
"properties":{
"propertyName":{
"type":"string",
"description":"Name of the placeholder property in the template body. Some examples: NTF_DCS_ADV_EVENT, NTF_SIGN_OVERDUE, NTF_HEADER_C1, NTF_HEADER_SITE_NAME, NTF_HEADER_STUDY_MODE, NTF_HEADER_STUDY_NAME etc",
"example":"NTF_HEADER_SITE_NAME"
},
"propertyValue":{
"type":"string",
"description":"Value of the placeholder property prior to anchor substitution. Some examples: NTF_DCS_ADV_EVENT, NTF_SIGN_OVERDUE, NTF_HEADER_C1, NTF_HEADER_SITE_NAME, NTF_HEADER_STUDY_MODE, NTF_HEADER_STUDY_NAME etc ",
"example":"NTF_HEADER_SITE_NAME"
},
"anchors":{
"type":"array",
"description":"Anchors used to substitute dynamic portions within the property value",
"items":{
"$ref":"#/components/schemas/Anchors"
}
}
},
"description":"Represents a single placeholder property in the template body, optionally including anchors for parameterized substitution."
},
"Subject":{
"type":"object",
"properties":{
"anchorKey":{
"type":"string",
"description":"Message key used to resolve the localized email subject text.",
"example":"NTF_SIGN_OVERDUE"
},
"anchorValues":{
"$ref":"#/components/schemas/AnchorValues"
}
},
"description":"Structured subject definition for i18n templates. Provides a message key and a collection of anchor values for substitution."
},
"NotificationLogDto":{
"required":[
"approvalFlag",
"category",
"createdBy",
"entityType",
"immediateFlag",
"priority",
"serviceName"
],
"type":"object",
"properties":{
"serviceName":{
"type":"string",
"description":"Service name that generated the notification",
"example":"dc",
"enum":[
"dc",
"ors",
"reporting",
"ruledesigner",
"sites"
]
},
"messageSubject":{
"maxLength":1024,
"minLength":0,
"type":"string",
"description":"Subject/title of the notification",
"example":"Cancellation Shipment Request"
},
"messageDescription":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Detailed message body of the notification",
"example":"Drug Order ID: 09009 Original Request Date: Eastern Time (US & Canada): 21-May-2012 9:45 PM Manual Request Date: Eastern Time (US & Canada): 19-Jul-2016 3:56 PM Site ID: 50 Site Name: UAT, Claudia Darija Site Address: 12 West RD, Phoenix, AZ Requestor Name: Eva, Haulage Email: eva.hulshagen@oracle.com Please complete the manual request here. If you do not have the access to the drug supply system, please contact the sponsor to verify you have received the cancel request and the drugs listed in this shipment have not left the possession of the depot."
},
"priority":{
"type":"string",
"description":"Priority of the notification",
"example":"HIGH",
"enum":[
"LOW",
"HIGH",
"0",
"1"
]
},
"entityType":{
"type":"string",
"description":"Entity type associated with the notification. Some examples: Study, Site, Subject.",
"example":"Site"
},
"category":{
"type":"string",
"description":"Functional category of the notification. Some examples: Shipment Failure, Site state Change, Report Generation etc.",
"example":"Report Generation"
},
"privilege":{
"type":"string",
"description":"Business right or privilege associated with this notification. Some examples: SiteStatusChangeNotification, ReportNotification",
"example":"SiteStatusChangeNotification"
},
"createdBy":{
"type":"string",
"description":"User or process that created the notification",
"example":"Eva, Hulshagen"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Inventory control system failure"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Shipment Failure Notification"
},
"entityId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the entity for which the property applies.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"approvalFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Approval flag indicating if approval is required",
"example":"Y",
"enum":[
"Y",
"N"
]
},
"createdDate":{
"type":"string",
"description":"Creation timestamp of the notification",
"format":"date-time",
"example":"2025-03-21T10:20:30Z"
},
"userList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of user identifiers targeted by this notification",
"example":"1BC29B36F5D64B1B95F4B987CEA481BE,1BC29B36F5D64B1B95F4BD234EA481BE"
},
"immediateFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Immediate processing flag",
"example":"n",
"enum":[
"y",
"n"
]
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D79F8A8A1B9E4F9A9A25E3B3B1C2D3E4"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"example":"2025-03-20T10:20:30.000Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"example":"2025-03-21T10:20:30.000Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"id":{
"type":"string",
"description":"Unique identifier of the notification log record (UUID, 32-character uppercase hexadecimal string)",
"example":"33D0D74837F6454B836AAB5BA2574D28"
},
"SoftwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":1
},
"notificationDateTime":{
"type":"string",
"description":"Time when the notification was sent or scheduled",
"example":"2025-03-21T10:20:30.000Z"
},
"ObjectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
}
},
"description":"Notification log record describing the notification content, recipients, audit fields, and versioning metadata"
},
"NotificationLogDto2":{
"required":[
"approvalFlag",
"category",
"createdBy",
"entityType",
"immediateFlag",
"priority",
"serviceName"
],
"type":"object",
"properties":{
"serviceName":{
"type":"string",
"description":"Service name that generated the notification",
"example":"dc",
"enum":[
"dc",
"ors",
"reporting",
"ruledesigner",
"sites"
]
},
"messageSubject":{
"maxLength":1024,
"minLength":0,
"type":"string",
"description":"Subject/title of the notification",
"example":"Cancellation Shipment Request"
},
"messageDescription":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Detailed message body of the notification",
"example":"Drug Order ID: 09009 Original Request Date: Eastern Time (US & Canada): 21-May-2012 9:45 PM Manual Request Date: Eastern Time (US & Canada): 19-Jul-2016 3:56 PM Site ID: 50 Site Name: UAT, Claudia Darija Site Address: 12 West RD, Phoenix, AZ Requestor Name: Eva, Haulage Email: eva.hulshagen@oracle.com Please complete the manual request here. If you do not have the access to the drug supply system, please contact the sponsor to verify you have received the cancel request and the drugs listed in this shipment have not left the possession of the depot."
},
"priority":{
"type":"string",
"description":"Priority of the notification",
"example":"HIGH",
"enum":[
"LOW",
"HIGH",
"0",
"1"
]
},
"entityType":{
"type":"string",
"description":"Entity type associated with the notification. Some examples: Study, Site, Subject.",
"example":"Site"
},
"category":{
"type":"string",
"description":"Functional category of the notification. Some examples: Shipment Failure, Site state Change, Report Generation etc.",
"example":"Report Generation"
},
"privilege":{
"type":"string",
"description":"Business right or privilege associated with this notification. Some examples: SiteStatusChangeNotification, ReportNotification",
"example":"SiteStatusChangeNotification"
},
"createdBy":{
"type":"string",
"description":"User or process that created the notification",
"example":"Eva, Hulshagen"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Inventory control system failure"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Shipment Failure Notification"
},
"entityId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the entity for which the property applies.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"approvalFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Approval flag indicating if approval is required",
"example":"Y",
"enum":[
"Y",
"N"
]
},
"createdDate":{
"type":"string",
"description":"Creation timestamp of the notification",
"format":"date-time",
"example":"2025-03-21T10:20:30Z"
},
"userList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of user identifiers targeted by this notification",
"example":"1BC29B36F5D64B1B95F4B987CEA481BE,1BC29B36F5D64B1B95F4BD234EA481BE"
},
"immediateFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Immediate processing flag",
"example":"n",
"enum":[
"y",
"n"
]
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D79F8A8A1B9E4F9A9A25E3B3B1C2D3E4"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"example":"2025-03-20T10:20:30.000Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"example":"2025-03-21T10:20:30.000Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"id":{
"type":"string",
"description":"Unique identifier of the notification log record (UUID, 32-character uppercase hexadecimal string)",
"example":"33D0D74837F6454B836AAB5BA2574D28"
},
"emailAddressList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of email addresses",
"example":"john.doe@oracle.com,jane.doe@oracle.com"
},
"attachment":{
"type":"string",
"description":"Attachment content as base64 encoded bytes",
"example":"SGVsbG8gd29ybGQh11"
},
"emailOnlyFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Send only email without in-app notification",
"example":"n",
"enum":[
"y",
"n"
]
},
"attachmentUrl":{
"type":"string",
"description":"Attachment URL reference when content is not embedded",
"example":"null"
},
"attachmentUrlProvider":{
"type":"string",
"description":"Provider of the attachment URL",
"example":"null"
},
"attachmentProviderVersion":{
"type":"string",
"description":"Provider API version used to generate the attachment URL",
"example":"null"
},
"SoftwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":1
},
"notificationDateTime":{
"type":"string",
"description":"Time when the notification was sent or scheduled",
"example":"2025-03-21T10:20:30.000Z"
},
"ObjectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
}
},
"description":"Notification log v2 payload with email delivery fields including attachments and provider metadata"
},
"NotificationLogDto3":{
"required":[
"approvalFlag",
"category",
"createdBy",
"entityType",
"immediateFlag",
"priority",
"serviceName"
],
"type":"object",
"properties":{
"serviceName":{
"type":"string",
"description":"Service name that generated the notification",
"example":"dc",
"enum":[
"dc",
"ors",
"reporting",
"ruledesigner",
"sites"
]
},
"messageSubject":{
"maxLength":1024,
"minLength":0,
"type":"string",
"description":"Subject/title of the notification",
"example":"Cancellation Shipment Request"
},
"messageDescription":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Detailed message body of the notification",
"example":"Drug Order ID: 09009 Original Request Date: Eastern Time (US & Canada): 21-May-2012 9:45 PM Manual Request Date: Eastern Time (US & Canada): 19-Jul-2016 3:56 PM Site ID: 50 Site Name: UAT, Claudia Darija Site Address: 12 West RD, Phoenix, AZ Requestor Name: Eva, Haulage Email: eva.hulshagen@oracle.com Please complete the manual request here. If you do not have the access to the drug supply system, please contact the sponsor to verify you have received the cancel request and the drugs listed in this shipment have not left the possession of the depot."
},
"priority":{
"type":"string",
"description":"Priority of the notification",
"example":"HIGH",
"enum":[
"LOW",
"HIGH",
"0",
"1"
]
},
"entityType":{
"type":"string",
"description":"Entity type associated with the notification. Some examples: Study, Site, Subject.",
"example":"Site"
},
"category":{
"type":"string",
"description":"Functional category of the notification. Some examples: Shipment Failure, Site state Change, Report Generation etc.",
"example":"Report Generation"
},
"privilege":{
"type":"string",
"description":"Business right or privilege associated with this notification. Some examples: SiteStatusChangeNotification, ReportNotification",
"example":"SiteStatusChangeNotification"
},
"createdBy":{
"type":"string",
"description":"User or process that created the notification",
"example":"Eva, Hulshagen"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Inventory control system failure"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Shipment Failure Notification"
},
"entityId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the entity for which the property applies.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"approvalFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Approval flag indicating if approval is required",
"example":"Y",
"enum":[
"Y",
"N"
]
},
"createdDate":{
"type":"string",
"description":"Creation timestamp of the notification",
"format":"date-time",
"example":"2025-03-21T10:20:30Z"
},
"userList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of user identifiers targeted by this notification",
"example":"1BC29B36F5D64B1B95F4B987CEA481BE,1BC29B36F5D64B1B95F4BD234EA481BE"
},
"immediateFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Immediate processing flag",
"example":"n",
"enum":[
"y",
"n"
]
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D79F8A8A1B9E4F9A9A25E3B3B1C2D3E4"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"example":"2025-03-20T10:20:30.000Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"example":"2025-03-21T10:20:30.000Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"id":{
"type":"string",
"description":"Unique identifier of the notification log record (UUID, 32-character uppercase hexadecimal string)",
"example":"33D0D74837F6454B836AAB5BA2574D28"
},
"emailAddressList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of email addresses",
"example":"john.doe@oracle.com,jane.doe@oracle.com"
},
"attachment":{
"type":"string",
"description":"Attachment content as base64 encoded bytes",
"example":"SGVsbG8gd29ybGQh11"
},
"emailOnlyFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Send only email without in-app notification",
"example":"n",
"enum":[
"y",
"n"
]
},
"attachmentUrl":{
"type":"string",
"description":"Attachment URL reference when content is not embedded",
"example":"null"
},
"attachmentUrlProvider":{
"type":"string",
"description":"Provider of the attachment URL",
"example":"null"
},
"attachmentProviderVersion":{
"type":"string",
"description":"Provider API version used to generate the attachment URL",
"example":"null"
},
"targetList":{
"type":"array",
"description":"List on ORS site information",
"items":{
"$ref":"#/components/schemas/NotificationLogTargetDto"
}
},
"SoftwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":1
},
"notificationDateTime":{
"type":"string",
"description":"Time when the notification was sent or scheduled",
"example":"2025-03-21T10:20:30.000Z"
},
"ObjectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
}
},
"description":"Notification log v3 payload with list of notification logs target."
},
"NotificationLogTargetDto":{
"required":[
"targetId",
"targetType"
],
"type":"object",
"properties":{
"targetType":{
"type":"string",
"description":"Type of notification target. Some examples: SITE, DEPOT USER",
"example":"SITE"
},
"targetId":{
"type":"string",
"description":"Unique identifier(UUID, 32-character uppercase hexadecimal string) for the coding result target.",
"example":"515D8531E6A94B1BB238E58A572D8C80"
}
},
"description":"Target mapping linking a notification to an entity such as a site or depot"
},
"BodyDto":{
"required":[
"anchors"
],
"type":"object",
"properties":{
"htmlContent":{
"type":"string",
"description":"HTML content template for the notification body",
"example":"Clinical One |
| NTF_ORS_DEPOT_LOW_KIT |
| NTF_ORS_BODY_STUDY_NAME: Rave_Study |
| NTF_ORS_BODY_STUDY_ID: Rave_Study |
| NTF_ORS_BODY_STUDY_MODE: NTF_ORS_MODE_ACTIVE |
| NTF_ORS_NEW_SHIPMENT_DEPOT_ID: DEPO01 |
| NTF_ORS_NEW_SHIPMENT_DEPOT_NAME: DEPO-01 |
| NTF_ORS_DEPOT_ADDRESS: #6700, Park Street,Opposite to Redfort,Noida,IN,Delhi,577126 |
|
| NTF_ORS_KIT_TYPE_ID: KitB | NTF_ORS_KIT_TYPE_DESCRIPTION: KitB_Desc | NTF_ORS_CURRENT_INVENTORY_AVAILABLE: 0 |
| NTF_ORS_KIT_TYPE_ID: KitA | NTF_ORS_KIT_TYPE_DESCRIPTION: KitA_Desc | NTF_ORS_CURRENT_INVENTORY_AVAILABLE: 0 |
|
| NTF_ORS_DATE_ALERT_RAISED: NTF_ORS_DATE_PERFORMED |
"
},
"anchors":{
"type":"array",
"description":"List of body anchors and their substitution values",
"items":{
"$ref":"#/components/schemas/NotificationAnchorDto"
}
}
},
"description":"Notification body template including HTML content and anchors for variable substitution"
},
"MessageLanguageSupportedDto":{
"required":[
"body",
"subject"
],
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectDto"
},
"body":{
"$ref":"#/components/schemas/BodyDto"
}
},
"description":"Structure holding localized message subject and body content with anchor keys and value substitutions"
},
"NotificationAnchorDto":{
"type":"object",
"properties":{
"anchorKey":{
"type":"string",
"description":"Unique subject anchor key within the export payload. Some examples: NTF_ORS_DEPOT_LOW_KIT, NTF_ORS_BODY_STUDY_NAME, NTF_ORS_BODY_STUDY_ID, NTF_ORS_BODY_STUDY_MODE, NTF_ORS_MODE_ACTIVE, NTF_ORS_MODE_TEST, NTF_ORS_MODE_TRAINING, NTF_ORS_NEW_SHIPMENT_DEPOT_ID, NTF_ORS_NEW_SHIPMENT_DEPOT_NAME, NTF_ORS_DEPOT_ADDRESS, NTF_ORS_DATE_ALERT_RAISED, NTF_ORS_KIT_TYPE_ID, NTF_ORS_KIT_TYPE_DESCRIPTION, NTF_ORS_CURRENT_INVENTORY_AVAILABLE.",
"example":"NTF_ORS_DEPOT_LOW_KIT"
},
"values":{
"type":"array",
"description":"List of substitution values for this anchor",
"items":{
"$ref":"#/components/schemas/ValueDto"
}
}
},
"description":"Anchor replacement entry for localized message body with indexed anchors."
},
"NotificationLogDto4":{
"required":[
"approvalFlag",
"category",
"createdBy",
"entityType",
"immediateFlag",
"priority",
"serviceName"
],
"type":"object",
"properties":{
"serviceName":{
"type":"string",
"description":"Service name that generated the notification",
"example":"dc",
"enum":[
"dc",
"ors",
"reporting",
"ruledesigner",
"sites"
]
},
"messageSubject":{
"maxLength":1024,
"minLength":0,
"type":"string",
"description":"Subject/title of the notification",
"example":"Cancellation Shipment Request"
},
"messageDescription":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Detailed message body of the notification",
"example":"Drug Order ID: 09009 Original Request Date: Eastern Time (US & Canada): 21-May-2012 9:45 PM Manual Request Date: Eastern Time (US & Canada): 19-Jul-2016 3:56 PM Site ID: 50 Site Name: UAT, Claudia Darija Site Address: 12 West RD, Phoenix, AZ Requestor Name: Eva, Haulage Email: eva.hulshagen@oracle.com Please complete the manual request here. If you do not have the access to the drug supply system, please contact the sponsor to verify you have received the cancel request and the drugs listed in this shipment have not left the possession of the depot."
},
"priority":{
"type":"string",
"description":"Priority of the notification",
"example":"HIGH",
"enum":[
"LOW",
"HIGH",
"0",
"1"
]
},
"entityType":{
"type":"string",
"description":"Entity type associated with the notification. Some examples: Study, Site, Subject.",
"example":"Site"
},
"category":{
"type":"string",
"description":"Functional category of the notification. Some examples: Shipment Failure, Site state Change, Report Generation etc.",
"example":"Report Generation"
},
"privilege":{
"type":"string",
"description":"Business right or privilege associated with this notification. Some examples: SiteStatusChangeNotification, ReportNotification",
"example":"SiteStatusChangeNotification"
},
"createdBy":{
"type":"string",
"description":"User or process that created the notification",
"example":"Eva, Hulshagen"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Inventory control system failure"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Shipment Failure Notification"
},
"entityId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the entity for which the property applies.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"approvalFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Approval flag indicating if approval is required",
"example":"Y",
"enum":[
"Y",
"N"
]
},
"createdDate":{
"type":"string",
"description":"Creation timestamp of the notification",
"format":"date-time",
"example":"2025-03-21T10:20:30Z"
},
"userList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of user identifiers targeted by this notification",
"example":"1BC29B36F5D64B1B95F4B987CEA481BE,1BC29B36F5D64B1B95F4BD234EA481BE"
},
"immediateFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Immediate processing flag",
"example":"n",
"enum":[
"y",
"n"
]
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D79F8A8A1B9E4F9A9A25E3B3B1C2D3E4"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"example":"2025-03-20T10:20:30.000Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"example":"2025-03-21T10:20:30.000Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"id":{
"type":"string",
"description":"Unique identifier of the notification log record (UUID, 32-character uppercase hexadecimal string)",
"example":"33D0D74837F6454B836AAB5BA2574D28"
},
"emailAddressList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of email addresses",
"example":"john.doe@oracle.com,jane.doe@oracle.com"
},
"attachment":{
"type":"string",
"description":"Attachment content as base64 encoded bytes",
"example":"SGVsbG8gd29ybGQh11"
},
"emailOnlyFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Send only email without in-app notification",
"example":"n",
"enum":[
"y",
"n"
]
},
"attachmentUrl":{
"type":"string",
"description":"Attachment URL reference when content is not embedded",
"example":"null"
},
"attachmentUrlProvider":{
"type":"string",
"description":"Provider of the attachment URL",
"example":"null"
},
"attachmentProviderVersion":{
"type":"string",
"description":"Provider API version used to generate the attachment URL",
"example":"null"
},
"targetList":{
"type":"array",
"description":"List on ORS site information",
"items":{
"$ref":"#/components/schemas/NotificationLogTargetDto"
}
},
"messageLanguageSupported":{
"$ref":"#/components/schemas/MessageLanguageSupportedDto"
},
"SoftwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":1
},
"notificationDateTime":{
"type":"string",
"description":"Time when the notification was sent or scheduled",
"example":"2025-03-21T10:20:30.000Z"
},
"ObjectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
}
}
},
"SubjectDto":{
"type":"object",
"properties":{
"anchorKey":{
"type":"string",
"description":"Unique subject anchor key within the export payload. Some examples: NTF_ORS_DEPOT_LOW_KIT, NTF_ORS_BODY_STUDY_NAME, NTF_ORS_BODY_STUDY_ID, NTF_ORS_BODY_STUDY_MODE, NTF_ORS_MODE_ACTIVE, NTF_ORS_MODE_TEST, NTF_ORS_MODE_TRAINING, NTF_ORS_NEW_SHIPMENT_DEPOT_ID, NTF_ORS_NEW_SHIPMENT_DEPOT_NAME, NTF_ORS_DEPOT_ADDRESS, NTF_ORS_DATE_ALERT_RAISED, NTF_ORS_KIT_TYPE_ID, NTF_ORS_KIT_TYPE_DESCRIPTION, NTF_ORS_CURRENT_INVENTORY_AVAILABLE.",
"example":"NTF_ORS_DEPOT_LOW_KIT"
},
"values":{
"type":"array",
"description":"Collection of key-type-name entries for this subject",
"items":{
"$ref":"#/components/schemas/ValueDto"
}
}
},
"description":"Subject anchor and associated value entries",
"example":{
"anchorKey":"NTF_ORS_DEPOT_LOW_KIT",
"values":[
{
"key":"101",
"keyType":"VISIT",
"name":"Visit 1"
}
]
}
},
"ValueDto":{
"required":[
"keyType"
],
"type":"object",
"properties":{
"key":{
"type":"string",
"description":"Numeric key associated with the entry",
"example":"1"
},
"keyType":{
"type":"string",
"description":"Type/category for the key",
"example":"TEXT or DATE"
},
"name":{
"type":"string",
"description":"Human-readable label for the entry",
"example":"Visit 1"
}
},
"description":"Key, type, and display name entry for a subject"
},
"BodyDto2":{
"required":[
"anchors"
],
"type":"object",
"properties":{
"htmlContent":{
"type":"string",
"description":"HTML content template for the notification body",
"example":"Study updated"
},
"anchors":{
"type":"array",
"description":"List of body anchors with index and their substitution values",
"items":{
"$ref":"#/components/schemas/NotificationAnchorDto2"
}
}
},
"description":"Notification body template for v5 including HTML content and indexed anchors for deterministic replacement"
},
"MessageLanguageSupportedDto2":{
"required":[
"body",
"subject"
],
"type":"object",
"properties":{
"subject":{
"$ref":"#/components/schemas/SubjectDto"
},
"body":{
"$ref":"#/components/schemas/BodyDto2"
}
},
"description":"Structure holding localized message subject and body with indexed anchors for deterministic replacement order"
},
"NotificationAnchorDto2":{
"required":[
"anchorIndex"
],
"type":"object",
"properties":{
"anchorKey":{
"type":"string",
"description":"Unique subject anchor key within the export payload. Some examples: NTF_ORS_DEPOT_LOW_KIT, NTF_ORS_BODY_STUDY_NAME, NTF_ORS_BODY_STUDY_ID, NTF_ORS_BODY_STUDY_MODE, NTF_ORS_MODE_ACTIVE, NTF_ORS_MODE_TEST, NTF_ORS_MODE_TRAINING, NTF_ORS_NEW_SHIPMENT_DEPOT_ID, NTF_ORS_NEW_SHIPMENT_DEPOT_NAME, NTF_ORS_DEPOT_ADDRESS, NTF_ORS_DATE_ALERT_RAISED, NTF_ORS_KIT_TYPE_ID, NTF_ORS_KIT_TYPE_DESCRIPTION, NTF_ORS_CURRENT_INVENTORY_AVAILABLE.",
"example":"NTF_ORS_BODY_STUDY_NAME"
},
"anchorIndex":{
"type":"integer",
"description":"0-based index of the anchor occurrence within the message body.",
"example":0
},
"values":{
"type":"array",
"description":"List of substitution values for this anchor",
"items":{
"$ref":"#/components/schemas/ValueDto"
}
}
},
"description":"Anchor replacement entry for localized message body with indexed anchors."
},
"NotificationLogDto5":{
"required":[
"approvalFlag",
"category",
"createdBy",
"entityType",
"immediateFlag",
"priority",
"serviceName"
],
"type":"object",
"properties":{
"serviceName":{
"type":"string",
"description":"Service name that generated the notification",
"example":"dc",
"enum":[
"dc",
"ors",
"reporting",
"ruledesigner",
"sites"
]
},
"messageSubject":{
"maxLength":1024,
"minLength":0,
"type":"string",
"description":"Subject/title of the notification",
"example":"Cancellation Shipment Request"
},
"messageDescription":{
"maxLength":32767,
"minLength":0,
"type":"string",
"description":"Detailed message body of the notification",
"example":"Drug Order ID: 09009 Original Request Date: Eastern Time (US & Canada): 21-May-2012 9:45 PM Manual Request Date: Eastern Time (US & Canada): 19-Jul-2016 3:56 PM Site ID: 50 Site Name: UAT, Claudia Darija Site Address: 12 West RD, Phoenix, AZ Requestor Name: Eva, Haulage Email: eva.hulshagen@oracle.com Please complete the manual request here. If you do not have the access to the drug supply system, please contact the sponsor to verify you have received the cancel request and the drugs listed in this shipment have not left the possession of the depot."
},
"priority":{
"type":"string",
"description":"Priority of the notification",
"example":"HIGH",
"enum":[
"LOW",
"HIGH",
"0",
"1"
]
},
"entityType":{
"type":"string",
"description":"Entity type associated with the notification. Some examples: Study, Site, Subject.",
"example":"Site"
},
"category":{
"type":"string",
"description":"Functional category of the notification. Some examples: Shipment Failure, Site state Change, Report Generation etc.",
"example":"Report Generation"
},
"privilege":{
"type":"string",
"description":"Business right or privilege associated with this notification. Some examples: SiteStatusChangeNotification, ReportNotification",
"example":"SiteStatusChangeNotification"
},
"createdBy":{
"type":"string",
"description":"User or process that created the notification",
"example":"Eva, Hulshagen"
},
"reason":{
"maxLength":255,
"minLength":0,
"type":"string",
"description":"Reason",
"example":"Inventory control system failure"
},
"comment":{
"maxLength":2048,
"minLength":0,
"type":"string",
"description":"Comment",
"example":"Shipment Failure Notification"
},
"entityId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the entity for which the property applies.",
"example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
},
"approvalFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Approval flag indicating if approval is required",
"example":"Y",
"enum":[
"Y",
"N"
]
},
"createdDate":{
"type":"string",
"description":"Creation timestamp of the notification",
"format":"date-time",
"example":"2025-03-21T10:20:30Z"
},
"userList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of user identifiers targeted by this notification",
"example":"1BC29B36F5D64B1B95F4B987CEA481BE,1BC29B36F5D64B1B95F4BD234EA481BE"
},
"immediateFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Immediate processing flag",
"example":"n",
"enum":[
"y",
"n"
]
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D79F8A8A1B9E4F9A9A25E3B3B1C2D3E4"
},
"versionStart":{
"type":"string",
"description":"The timestamp marking the beginning of the validity period for this record version within the system.",
"example":"2025-03-20T10:20:30.000Z"
},
"versionEnd":{
"type":"string",
"description":"The end date until which the data is applicable or valid.",
"example":"2025-03-21T10:20:30.000Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"CREATED"
},
"id":{
"type":"string",
"description":"Unique identifier of the notification log record (UUID, 32-character uppercase hexadecimal string)",
"example":"33D0D74837F6454B836AAB5BA2574D28"
},
"emailAddressList":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Comma separated list of email addresses",
"example":"john.doe@oracle.com,jane.doe@oracle.com"
},
"attachment":{
"type":"string",
"description":"Attachment content as base64 encoded bytes",
"example":"SGVsbG8gd29ybGQh11"
},
"emailOnlyFlag":{
"maxLength":1,
"minLength":0,
"type":"string",
"description":"Send only email without in-app notification",
"example":"n",
"enum":[
"y",
"n"
]
},
"attachmentUrl":{
"type":"string",
"description":"Attachment URL reference when content is not embedded",
"example":"null"
},
"attachmentUrlProvider":{
"type":"string",
"description":"Provider of the attachment URL",
"example":"null"
},
"attachmentProviderVersion":{
"type":"string",
"description":"Provider API version used to generate the attachment URL",
"example":"null"
},
"targetList":{
"type":"array",
"description":"List on ORS site information",
"items":{
"$ref":"#/components/schemas/NotificationLogTargetDto"
}
},
"messageLanguageSupported":{
"$ref":"#/components/schemas/MessageLanguageSupportedDto2"
},
"SoftwareVersionNumber":{
"type":"number",
"description":"A number that represents an incremental increase every time a data point is modified.",
"example":1
},
"notificationDateTime":{
"type":"string",
"description":"Time when the notification was sent or scheduled",
"example":"2025-03-21T10:20:30.000Z"
},
"ObjectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":1
}
}
},
"NotificationPropertiesDto":{
"type":"object",
"properties":{
"notificationProperties":{
"type":"array",
"description":"List of notification properties",
"items":{
"$ref":"#/components/schemas/NotificationPropertyDto"
}
}
},
"description":"Collection of notification configuration properties for a study"
},
"NotificationPropertyDto":{
"required":[
"propertyName",
"propertyValue"
],
"type":"object",
"properties":{
"propertyName":{
"maxLength":100,
"minLength":0,
"type":"string",
"description":"Name of the notification property key",
"example":"showLogo",
"enum":[
"showLogo",
"helpdeskInfo"
]
},
"propertyValue":{
"maxLength":4000,
"minLength":0,
"type":"string",
"description":"Value of the notification property",
"example":"For assistance, contact support@example.com or +1-800-123-4567"
}
},
"description":"Key-value pair to configure a single notification property"
},
"NotificationsBroadcast":{
"required":[
"archiveDateTime",
"messageReadDateTime"
],
"type":"object",
"properties":{
"id":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) representing broadcast notification id.",
"example":"24C9C2B19F1B46ED964CD6653FC10791"
},
"versionStart":{
"type":"string",
"description":"Version start timestamp for this record.",
"format":"date-time",
"example":"2025-11-13T08:28:02.345Z"
},
"notificationLogId":{
"type":"string",
"description":"Unique id (UUID, 32-character uppercase hexadecimal string) linked to notification log.",
"example":"AB16747FB7DC4F26863979B26F58CBCD"
},
"userId":{
"type":"string",
"description":"Unique user identifier representing the clinicalone user who modified or interacted with the subject record. Uses UUID in a 32-character uppercase hexadecimal string format.",
"example":"D79F8A8A1B9E4F9A9A25E3B3B1C2D3E4"
},
"userName":{
"type":"string",
"description":"Target user's display name.",
"example":"system ClinicalOne"
},
"userEmailAddress":{
"type":"string",
"description":"Target user's email address.",
"format":"email",
"example":"test.user1@oracle.com"
},
"subscription":{
"type":"string",
"description":"Subscription status for the user to this notification type",
"example":"YES",
"enum":[
"YES",
"NO"
]
},
"messageReadDateTime":{
"type":"string",
"description":"Timestamp when the message was read.",
"example":"Sun Dec 31 00:00:00 GMT 3099"
},
"versionEnd":{
"type":"string",
"description":"Version end timestamp for this record.",
"format":"date-time",
"example":"3099-12-31T00:00:00Z"
},
"operationType":{
"type":"string",
"description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
"example":"MODIFIED"
},
"reason":{
"type":"string",
"description":"Reason",
"example":"New Report"
},
"archiveDateTime":{
"type":"string",
"description":"Timestamp when the message was archived.",
"example":"Sun Dec 31 00:00:00 GMT 3099"
},
"category":{
"type":"string",
"description":"Functional category of the notification. Some examples: Shipment Failure, Site state Change, Report Generation etc.",
"example":"Report Generation"
},
"emailAttemptDateTime":{
"type":"string",
"description":"Timestamp of the last email delivery attempt.",
"format":"date-time",
"example":"2025-11-13T08:28:02.345Z"
},
"updatedBy":{
"type":"string",
"description":"The user who last updated the record (UUID, 32-character uppercase hexadecimal string)",
"example":"225B79C982104415886DE02BC73C1E1E"
},
"softwareVersionNumber":{
"type":"number",
"description":"Software version number",
"example":1
},
"approvalFlag":{
"type":"string",
"description":"Approval flag indicating if approval is required.",
"example":"N",
"enum":[
"Y",
"N"
]
},
"notificationDateTime":{
"type":"string",
"description":"Time when the notification was sent or scheduled.",
"example":"Thu Nov 13 08:28:02 GMT 2025"
},
"comments":{
"type":"string",
"description":"Additional comments for the notification event.",
"example":"New Report"
},
"actionId":{
"type":"string",
"description":"Same value as notification id (UUID, 32-character uppercase hexadecimal string)",
"example":"24C9C2B19F1B46ED964CD6653FC10791"
},
"objectVersionNumber":{
"type":"number",
"description":"Audit trail field that represents the version number of the data.",
"example":2
}
},
"description":"Notification broadcast record representing a user-targeted notification with audit and delivery metadata"
},
"NotificationsDetailResponse":{
"type":"object",
"properties":{
"messageDescription":{
"type":"string",
"description":"Detailed notification message text.",
"example":"Study Design Report is now ready in Clinical One."
},
"messageSubject":{
"type":"string",
"description":"Subject or title of the notification message.",
"example":"S4-Copy | Study Design Report is ready in Clinical One"
},
"entityId":{
"type":"string",
"description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the entity for which the property applies.",
"example":"6153170BDE5244A0BB3DF169C4168483"
},
"entityType":{
"type":"string",
"description":"Type of entity associated with this notification. Some examples: STUDY, SUBJECT, SITE",
"example":"STUDY"
},
"notificationsBroadcast":{
"$ref":"#/components/schemas/NotificationsBroadcast"
}
},
"description":"Aggregated notification broadcast details combined with notification log metadata"
},
"NotificationCount":{
"type":"object",
"properties":{
"totalCount":{
"type":"number",
"description":"Total number of notifications available for the user and study.",
"example":12
},
"unreadCount":{
"type":"number",
"description":"Number of notifications that are unread for the user and study.",
"example":3
}
},
"description":"Counts of total notifications and unread notifications for the user and study."
},
"DataHubReportDto":{
"type":"object",
"properties":{
"hasMore":{
"type":"string",
"description":"String pagination flag (\"true\" or \"false\") indicating whether more matching rows exist after the current page.
Returned as a string for backward compatibility.
",
"example":"false"
},
"totalResults":{
"type":"integer",
"description":"Total number of matching rows across all pages after filters are applied.
This can be non-zero even when the current page is empty because the requested offset is beyond the last row.
",
"format":"int32",
"example":2
},
"count":{
"type":"integer",
"description":"Number of rows returned in the current page.
",
"format":"int32",
"example":2
},
"limit":{
"type":"integer",
"description":"Requested page size.
Dataset endpoints commonly use 0 to mean unpaginated or all rows.
",
"format":"int32",
"example":100
},
"offset":{
"type":"integer",
"description":"Zero-based row offset applied to the result set.
Dataset endpoints that disable pagination with limit = 0 typically echo offset = 0 in the response.
",
"format":"int32",
"example":0
},
"columns":{
"type":"array",
"description":"Ordered dataset column names selected by the client.
Each row in data uses this exact order.
",
"example":[
"STUDY_ID",
"RECORD_ID",
"STATUS"
],
"items":{
"type":"string",
"description":"Ordered dataset column names selected by the client.
Each row in data uses this exact order.
",
"example":"[\"STUDY_ID\",\"RECORD_ID\",\"STATUS\"]"
}
},
"data":{
"type":"array",
"description":"Row data aligned positionally with columns.
Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.
",
"example":[
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC001",
"Active"
],
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC002",
"Inactive"
]
],
"items":{
"type":"array",
"description":"Row data aligned positionally with columns.
Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.
",
"example":[
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC001",
"Active"
],
[
"A86F2D0BB610404DB62D37AFA9C20B50",
"REC002",
"Inactive"
]
],
"items":{
"type":"string",
"description":"Row data aligned positionally with columns.
Each cell is serialized as a JSON string or null, even for logical numbers and timestamps.
",
"example":"[[\"A86F2D0BB610404DB62D37AFA9C20B50\",\"REC001\",\"Active\"],[\"A86F2D0BB610404DB62D37AFA9C20B50\",\"REC002\",\"Inactive\"]]"
}
}
}
},
"description":"Tabular dataset response for a dynamic Data Hub query.
columns defines the selected output order, and each row in data aligns positionally to that list.
"
},
"DataHubResponse":{
"type":"object",
"properties":{
"status":{
"type":"string",
"description":"Overall request processing status.
Allowed values are \"success\" and \"failed\".
",
"example":"success"
},
"result":{
"type":"object",
"description":"Payload returned by the API when status is \"success\".
This field is null when status is \"failed\".
",
"example":{
"message":"Operation succeeded"
}
},
"errorData":{
"type":"object",
"description":"Machine-readable error payload when status is \"failed\".
This field is null when status is \"success\".
",
"example":{
"errorCode":"VALIDATION_ERROR",
"errorMessage":"Invalid column name specified in the select columns: SITE_ID1",
"details":{
"field":"selectColumns"
}
}
},
"version":{
"type":"integer",
"description":"Envelope version number.",
"format":"int32",
"example":1
}
},
"description":"Standard Data Hub response envelope.
Successful responses return status as \"success\" and populate result. Failed responses return status as \"failed\" and populate errorData.
"
},
"Status":{
"type":"object",
"properties":{
"description":{
"type":"string"
},
"code":{
"type":"string"
}
}
},
"DataHubQueryDto":{
"type":"object",
"properties":{
"selectColumns":{
"type":"array",
"description":"Required non-empty list of dataset column names to return.
Column validation is case-insensitive, and the response echoes canonical uppercase dataset column names in the same order.
",
"example":[
"STUDY_VERSION",
"STUDY_ID"
],
"items":{
"type":"string",
"description":"Required non-empty list of dataset column names to return.
Column validation is case-insensitive, and the response echoes canonical uppercase dataset column names in the same order.
",
"example":"[\"STUDY_VERSION\",\"STUDY_ID\"]"
}
},
"whereColumns":{
"type":"array",
"description":"Optional structured filter predicates.
This is the request-body equivalent of a WHERE clause.
All predicate values are supplied as strings and are parsed according to the underlying dataset column type.
",
"example":[
{
"columnName":"STUDY_ID",
"operator":"=",
"value":[
"A86F2D0BB610404DB62D37AFA9C20B50"
]
}
],
"items":{
"$ref":"#/components/schemas/QueryPredicate"
}
},
"orderColumns":{
"type":"array",
"description":"Optional sort instructions to apply to the result set.
Duplicate order-by columns are rejected.
",
"example":[
{
"columnName":"VERSION_START",
"sortOrder":"ASC"
}
],
"items":{
"$ref":"#/components/schemas/QueryOrder"
}
}
},
"description":"Submit a structured query for a Data Hub dataset.
\n\n"
},
"QueryOrder":{
"type":"object",
"properties":{
"columnName":{
"type":"string",
"description":"Required dataset column name to sort by.
Column-name validation is case-insensitive.
",
"example":"VERSION_START"
},
"sortOrder":{
"type":"string",
"description":"Optional sort direction.
If omitted, SQL default ascending order is used for that column. Allowed values are ASC and DESC.
",
"example":"ASC",
"enum":[
"ASC",
"DESC"
]
}
},
"description":"Sort instruction specifying a dataset column and optional order direction.
",
"example":[
{
"columnName":"VERSION_START",
"sortOrder":"ASC"
}
]
},
"QueryPredicate":{
"type":"object",
"properties":{
"columnName":{
"type":"string",
"description":"Required dataset column name to filter on. Column-name validation is case-insensitive.",
"example":"STUDY_ID"
},
"operator":{
"type":"string",
"description":"Required comparison operator. Use one value for =, !=, <>, >, >=, <, <=, LIKE, and NOT LIKE; one or more values for IN and NOT IN; exactly two values for BETWEEN and NOT BETWEEN; and exactly one value equal to NULL for IS and IS NOT.",
"example":"=",
"enum":[
">",
"<",
"=",
">=",
"<=",
"<>",
"!=",
"IN",
"NOT IN",
"BETWEEN",
"NOT BETWEEN",
"LIKE",
"NOT LIKE",
"IS",
"IS NOT"
]
},
"value":{
"type":"array",
"description":"Filter values as strings. Value cardinality depends on the operator: one for most operators, one or more for IN/NOT IN, exactly two for BETWEEN/NOT BETWEEN, and exactly one value equal to NULL for IS/IS NOT.",
"example":[
"A86F2D0BB610404DB62D37AFA9C20B50"
],
"items":{
"type":"string",
"description":"Filter values as strings. Value cardinality depends on the operator: one for most operators, one or more for IN/NOT IN, exactly two for BETWEEN/NOT BETWEEN, and exactly one value equal to NULL for IS/IS NOT.",
"example":"[\"A86F2D0BB610404DB62D37AFA9C20B50\"]"
}
}
},
"description":"Structured filter predicate used to constrain dataset results by column, operator, and value",
"example":[
{
"columnName":"STUDY_ID",
"operator":"=",
"value":[
"A86F2D0BB610404DB62D37AFA9C20B50"
]
}
]
},
"DHSyncDto":{
"type":"object",
"properties":{
"mode":{
"type":"string",
"description":"Mode of the Study. Valid values are design, test, active, or training.",
"example":"active"
},
"dhSyncTimestamp":{
"type":"string",
"description":"Datahub last sync up timstamp",
"format":"date-time",
"example":"2025-10-16T14:30:31.892Z"
}
},
"description":"Datahub Sync up details including last sync up timestamp and mode."
},
"DataHubSingleReportDto":{
"type":"object",
"properties":{
"columns":{
"type":"array",
"description":"Names of the columns included in each row",
"example":[
"STUDY_TITLE",
"STUDY_REFNAME",
"STUDY_ID"
],
"items":{
"type":"string",
"description":"Names of the columns included in each row",
"example":"[\"STUDY_TITLE\",\"STUDY_REFNAME\",\"STUDY_ID\"]"
}
},
"data":{
"type":"array",
"description":"Row data aligned with the columns list",
"example":[
"My study",
"MY_STUDY",
"E8230E450E844721A67F8EBFF71B160D"
],
"items":{
"type":"string",
"description":"Row data aligned with the columns list",
"example":"[\"My study\",\"MY_STUDY\",\"E8230E450E844721A67F8EBFF71B160D\"]"
}
}
},
"description":"Single report result of the dynamic query execution"
},
"Address":{
"type":"object",
"properties":{
"streetName":{
"type":"array",
"xml":{
"name":"StreetName"
},
"items":{
"$ref":"#/components/schemas/StreetName"
}
},
"city":{
"$ref":"#/components/schemas/City"
},
"stateProv":{
"$ref":"#/components/schemas/StateProv"
},
"country":{
"$ref":"#/components/schemas/Country"
},
"postalCode":{
"$ref":"#/components/schemas/PostalCode"
},
"otherText":{
"$ref":"#/components/schemas/OtherText"
}
}
},
"AdminDataODMExtV1":{
"type":"object",
"properties":{
"adminData":{
"type":"object",
"properties":{
"user":{
"type":"array",
"items":{
"$ref":"#/components/schemas/User"
}
},
"location":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Location"
}
},
"signatureDef":{
"type":"array",
"xml":{
"name":"SignatureDef"
},
"items":{
"$ref":"#/components/schemas/SignatureDef"
}
},
"studyOID":{
"type":"string",
"xml":{
"name":"StudyOID",
"attribute":true
}
}
},
"description":"List of AdminData sections with users, locations and related metadata.",
"example":[
],
"xml":{
"name":"AdminData",
"namespace":"http://www.cdisc.org/ns/odm/v1.3"
}
},
"studyMode":{
"type":"string",
"description":"Study mode for which data is requested.",
"example":"active",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"includeCOExtensions":{
"type":"string",
"description":"Whether to include Clinical One specific ODM extensions.",
"example":"true",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
},
"enum":[
"true",
"false"
]
},
"excludeHiddenData":{
"type":"string",
"description":"Whether to exclude hidden data.",
"example":"false",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
},
"enum":[
"true",
"false"
]
},
"fromDate":{
"type":"string",
"description":"Filter start timestamp for the extract.",
"format":"date-time",
"example":"2023-01-01T00:00:00Z",
"xml":{
"name":"fromTimestamp",
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"toDate":{
"type":"string",
"description":"Filter end timestamp for the extract.",
"format":"date-time",
"example":"2023-12-31T23:59:59.999Z",
"xml":{
"name":"toTimestamp",
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"studyVersion":{
"type":"string",
"description":"Study version identifier.",
"example":"1.0",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"studyVersionSummary":{
"type":"boolean",
"description":"Indicates if only a summary of the study version is included.",
"example":false,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"includeUsers":{
"type":"string",
"description":"Whether to include users in the extract.",
"example":"true",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
},
"enum":[
"true",
"false"
]
},
"includeLocations":{
"type":"string",
"description":"Whether to include locations in the extract.",
"example":"true",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
},
"enum":[
"true",
"false"
]
},
"hasMore":{
"type":"boolean",
"description":"Indicates if additional results are available beyond the current page.",
"example":false,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"totalResults":{
"type":"integer",
"description":"Total number of results available for the request.",
"format":"int32",
"example":250,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"count":{
"type":"integer",
"description":"Number of results included in this response.",
"format":"int32",
"example":100,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"limit":{
"minimum":1,
"type":"integer",
"description":"Maximum number of results per page.",
"format":"int32",
"example":100,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"offset":{
"type":"integer",
"description":"Index of the first result returned in this page.",
"format":"int32",
"example":0,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"description":{
"type":"string",
"description":"Human readable description of this extract.",
"example":"Administrative data extract",
"xml":{
"name":"Description",
"attribute":true
}
},
"fileType":{
"type":"string",
"description":"ODM file type that indicates whether the export is a full snapshot or a transactional change set.",
"example":"",
"xml":{
"name":"FileType",
"attribute":true
},
"enum":[
"SNAPSHOT",
"TRANSACTIONAL",
"Snapshot",
"Transactional"
]
},
"Granularity":{
"type":"string",
"description":"Granularity of ODM data export.",
"format":"string",
"example":"All",
"xml":{
"attribute":true
},
"enum":[
"ALL",
"METADATA",
"ADMIN_DATA",
"REFERENCE_DATA",
"ALL_CLINICAL_DATA",
"SINGLE_SITE",
"SINGLE_SUBJECT",
"All",
"Metadata",
"AdminData",
"ReferenceData",
"AllClinicalData",
"SingleSite",
"SingleSubject"
]
},
"archival":{
"type":"string",
"description":"Indicates whether this is an archival extract.",
"example":"Yes",
"xml":{
"name":"Archival",
"attribute":true
}
},
"fileOID":{
"type":"string",
"description":"Unique identifier for the extract file.",
"example":"EC942244BB30163BE053BEC44C64CF34",
"xml":{
"name":"FileOID",
"attribute":true
}
},
"creationDateTime":{
"type":"string",
"description":"Timestamp when the file was created.",
"format":"date-time",
"example":"2023-12-31T23:59:59.999Z",
"xml":{
"name":"CreationDateTime",
"attribute":true
}
},
"priorFileOID":{
"type":"string",
"description":"Identifier of the prior extract file, if applicable.",
"example":"F7D4C8B9E0E94485A4B3B2A3D6C7E8F9",
"xml":{
"name":"PriorFileOID",
"attribute":true
}
},
"asOfDateTime":{
"type":"string",
"description":"As-of timestamp for the snapshot.",
"format":"date-time",
"example":"2023-12-31T23:59:59.999Z",
"xml":{
"name":"AsOfDateTime",
"attribute":true
}
},
"odmVersion":{
"type":"string",
"description":"ODM specification version.",
"example":"1.3.2",
"xml":{
"name":"ODMVersion",
"attribute":true
}
},
"originator":{
"type":"string",
"description":"System or organization that originated the extract.",
"example":"ClinicalOne",
"xml":{
"name":"Originator",
"attribute":true
}
},
"sourceSystem":{
"type":"string",
"description":"Name of the source system.",
"example":"DataHub",
"xml":{
"name":"SourceSystem",
"attribute":true
}
},
"sourceSystemVersion":{
"type":"string",
"description":"Version of the source system.",
"example":"Admin Data ODM 1.0",
"xml":{
"name":"SourceSystemVersion",
"attribute":true
}
},
"id":{
"type":"string",
"description":"Identifier of this ODM root element instance.",
"example":"B4E5C6D7A8F90123ABCDEF4567890ABC",
"xml":{
"name":"ID",
"attribute":true
}
}
},
"description":"ODM AdminData response root element containing administrative data and Clinical One specific metadata including pagination and extract attributes.",
"example":"\n\n\t\n\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\n\t\n",
"xml":{
"name":"ODM"
}
},
"City":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"Country":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"DisplayName":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"Email":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"Fax":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"FirstName":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"FullName":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"LastName":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"LegalReason":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"Location":{
"required":[
"metaDataVersionRef"
],
"type":"object",
"properties":{
"metaDataVersionRef":{
"type":"array",
"xml":{
"name":"MetaDataVersionRef"
},
"items":{
"$ref":"#/components/schemas/MetaDataVersionRef"
}
},
"oid":{
"type":"string",
"xml":{
"name":"OID",
"attribute":true
}
},
"name":{
"type":"string",
"xml":{
"name":"Name",
"attribute":true
}
},
"locationType":{
"type":"string",
"xml":{
"name":"LocationType",
"attribute":true
},
"enum":[
"SPONSOR",
"SITE",
"CRO",
"LAB",
"OTHER"
]
}
},
"xml":{
"name":"Location",
"namespace":"http://www.cdisc.org/ns/odm/v1.3"
}
},
"LocationRef":{
"type":"object",
"properties":{
"locationOID":{
"type":"string",
"xml":{
"name":"LocationOID",
"attribute":true
}
}
}
},
"LoginName":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"Meaning":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"MetaDataVersionRef":{
"type":"object",
"properties":{
"studyOID":{
"type":"string",
"xml":{
"name":"StudyOID",
"attribute":true
}
},
"metaDataVersionOID":{
"type":"string",
"xml":{
"name":"MetaDataVersionOID",
"attribute":true
}
},
"effectiveDate":{
"type":"string",
"format":"date-time",
"xml":{
"name":"EffectiveDate",
"attribute":true
}
}
}
},
"Organization":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"OtherText":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"Pager":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"Picture":{
"type":"object",
"properties":{
"pictureFileName":{
"type":"string",
"xml":{
"name":"PictureFileName",
"attribute":true
}
},
"imageType":{
"type":"string",
"xml":{
"name":"ImageType",
"attribute":true
}
}
}
},
"PostalCode":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"SignatureDef":{
"required":[
"legalReason",
"meaning"
],
"type":"object",
"properties":{
"meaning":{
"$ref":"#/components/schemas/Meaning"
},
"legalReason":{
"$ref":"#/components/schemas/LegalReason"
},
"oid":{
"type":"string",
"xml":{
"name":"OID",
"attribute":true
}
},
"methodology":{
"type":"string",
"xml":{
"name":"Methodology",
"attribute":true
},
"enum":[
"DIGITAL",
"ELECTRONIC"
]
}
}
},
"StateProv":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"StreetName":{
"type":"object",
"properties":{
"value":{
"type":"string"
}
}
},
"User":{
"type":"object",
"properties":{
"loginName":{
"$ref":"#/components/schemas/LoginName"
},
"displayName":{
"$ref":"#/components/schemas/DisplayName"
},
"fullName":{
"$ref":"#/components/schemas/FullName"
},
"firstName":{
"$ref":"#/components/schemas/FirstName"
},
"lastName":{
"$ref":"#/components/schemas/LastName"
},
"organization":{
"$ref":"#/components/schemas/Organization"
},
"address":{
"type":"array",
"xml":{
"name":"Address"
},
"items":{
"$ref":"#/components/schemas/Address"
}
},
"email":{
"type":"array",
"xml":{
"name":"Email"
},
"items":{
"$ref":"#/components/schemas/Email"
}
},
"picture":{
"$ref":"#/components/schemas/Picture"
},
"pager":{
"$ref":"#/components/schemas/Pager"
},
"fax":{
"type":"array",
"xml":{
"name":"Fax"
},
"items":{
"$ref":"#/components/schemas/Fax"
}
},
"phone":{
"type":"array",
"xml":{
"name":"Phone"
},
"items":{
"$ref":"#/components/schemas/Phone"
}
},
"locationRef":{
"type":"array",
"xml":{
"name":"LocationRef"
},
"items":{
"$ref":"#/components/schemas/LocationRef"
}
},
"certificate":{
"type":"array",
"xml":{
"name":"Certificate"
},
"items":{
"$ref":"#/components/schemas/Certificate"
}
},
"oid":{
"type":"string",
"xml":{
"name":"OID",
"attribute":true
}
},
"userType":{
"type":"string",
"xml":{
"name":"UserType",
"attribute":true
},
"enum":[
"SPONSOR",
"INVESTIGATOR",
"LAB",
"OTHER"
]
}
},
"xml":{
"name":"User",
"namespace":"http://www.cdisc.org/ns/odm/v1.3"
}
},
"adminData":{
"type":"object",
"properties":{
"user":{
"type":"array",
"items":{
"$ref":"#/components/schemas/User"
}
},
"location":{
"type":"array",
"items":{
"$ref":"#/components/schemas/Location"
}
},
"signatureDef":{
"type":"array",
"xml":{
"name":"SignatureDef"
},
"items":{
"$ref":"#/components/schemas/SignatureDef"
}
},
"studyOID":{
"type":"string",
"xml":{
"name":"StudyOID",
"attribute":true
}
}
},
"description":"List of AdminData sections with users, locations and related metadata.",
"example":[
],
"xml":{
"name":"AdminData",
"namespace":"http://www.cdisc.org/ns/odm/v1.3"
}
},
"Annotation":{
"type":"object",
"properties":{
"comment":{
"$ref":"#/components/schemas/Comment"
},
"flag":{
"type":"array",
"xml":{
"name":"Flag"
},
"items":{
"$ref":"#/components/schemas/Flag"
}
},
"seqNum":{
"type":"integer",
"xml":{
"name":"SeqNum",
"attribute":true
}
},
"transactionType":{
"type":"string",
"xml":{
"name":"TransactionType",
"attribute":true
},
"enum":[
"INSERT",
"UPDATE",
"REMOVE",
"UPSERT",
"CONTEXT"
]
},
"id":{
"type":"string",
"xml":{
"name":"ID",
"attribute":true
}
}
},
"xml":{
"name":"Annotation",
"namespace":"http://www.cdisc.org/ns/odm/v1.3"
}
},
"Annotations":{
"type":"object",
"properties":{
"annotation":{
"type":"array",
"xml":{
"name":"Annotation"
},
"items":{
"$ref":"#/components/schemas/Annotation"
}
}
}
},
"ArchiveLayoutRef":{
"type":"object",
"properties":{
"archiveLayoutOID":{
"type":"string",
"xml":{
"name":"ArchiveLayoutOID",
"attribute":true
}
}
}
},
"AuditRecord":{
"required":[
"dateTimeStamp",
"locationRef",
"userRef"
],
"type":"object",
"properties":{
"userRef":{
"$ref":"#/components/schemas/UserRef"
},
"locationRef":{
"$ref":"#/components/schemas/LocationRef"
},
"dateTimeStamp":{
"$ref":"#/components/schemas/DateTimeStamp"
},
"reasonForChange":{
"$ref":"#/components/schemas/ReasonForChange"
},
"sourceID":{
"$ref":"#/components/schemas/SourceID"
},
"editPoint":{
"type":"string",
"xml":{
"name":"EditPoint",
"attribute":true
},
"enum":[
"MONITORING",
"DATA_MANAGEMENT",
"DB_AUDIT"
]
},
"usedImputationMethod":{
"type":"string",
"description":"Represents a Yes or No value.",
"example":"Yes",
"xml":{
"name":"UsedImputationMethod",
"attribute":true
},
"enum":[
"YES",
"NO",
"Yes",
"No"
]
},
"id":{
"type":"string",
"xml":{
"name":"ID",
"attribute":true
}
}
}
},
"AuditRecords":{
"type":"object",
"properties":{
"auditRecord":{
"type":"array",
"xml":{
"name":"AuditRecord"
},
"items":{
"$ref":"#/components/schemas/AuditRecord"
}
}
}
},
"ClinicalData":{
"type":"object",
"properties":{
"subjectData":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectData"
}
},
"auditRecords":{
"type":"array",
"xml":{
"name":"AuditRecords"
},
"items":{
"$ref":"#/components/schemas/AuditRecords"
}
},
"signatures":{
"type":"array",
"xml":{
"name":"Signatures"
},
"items":{
"$ref":"#/components/schemas/Signatures"
}
},
"annotations":{
"type":"array",
"xml":{
"name":"Annotations"
},
"items":{
"$ref":"#/components/schemas/Annotations"
}
},
"studyOID":{
"type":"string",
"xml":{
"name":"StudyOID",
"attribute":true
}
},
"metaDataVersionOID":{
"type":"string",
"xml":{
"name":"MetaDataVersionOID",
"attribute":true
}
}
},
"description":"List of ClinicalData elements describing study clinical content.",
"xml":{
"name":"ClinicalData",
"namespace":"http://www.cdisc.org/ns/odm/v1.3"
}
},
"ClinicalDataODMExtV1":{
"type":"object",
"properties":{
"clinicalData":{
"type":"object",
"properties":{
"subjectData":{
"type":"array",
"items":{
"$ref":"#/components/schemas/SubjectData"
}
},
"auditRecords":{
"type":"array",
"xml":{
"name":"AuditRecords"
},
"items":{
"$ref":"#/components/schemas/AuditRecords"
}
},
"signatures":{
"type":"array",
"xml":{
"name":"Signatures"
},
"items":{
"$ref":"#/components/schemas/Signatures"
}
},
"annotations":{
"type":"array",
"xml":{
"name":"Annotations"
},
"items":{
"$ref":"#/components/schemas/Annotations"
}
},
"studyOID":{
"type":"string",
"xml":{
"name":"StudyOID",
"attribute":true
}
},
"metaDataVersionOID":{
"type":"string",
"xml":{
"name":"MetaDataVersionOID",
"attribute":true
}
}
},
"description":"List of ClinicalData elements describing study clinical content.",
"xml":{
"name":"ClinicalData",
"namespace":"http://www.cdisc.org/ns/odm/v1.3"
}
},
"studyMode":{
"type":"string",
"description":"Study mode context in which the data is extracted. Possible values are test, active or training.",
"example":"active",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"includeCOExtensions":{
"type":"boolean",
"description":"Indicates whether Clinical One specific extensions are included in the payload.",
"example":true,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"excludeHiddenData":{
"type":"boolean",
"description":"If true, data marked as hidden is excluded from the response.",
"example":true,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"fromDate":{
"type":"string",
"description":"Filter results from this timestamp (inclusive). RFC 3339 format.",
"format":"date",
"example":"2023-01-01",
"xml":{
"name":"fromTimestamp",
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"toDate":{
"type":"string",
"description":"Filter results up to this timestamp (inclusive). RFC 3339 format.",
"format":"date",
"example":"2023-12-31",
"xml":{
"name":"toTimestamp",
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"studyVersion":{
"type":"string",
"description":"Study version identifier from which the data is produced.",
"example":"1.0.0.1",
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"studyVersionSummary":{
"type":"boolean",
"description":"Indicates whether the study version summary is included.",
"example":false,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"includeUsers":{
"type":"boolean",
"description":"Whether to include user information.",
"example":false,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"includeLocations":{
"type":"boolean",
"description":"Whether to include location information.",
"example":false,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"hasMore":{
"type":"boolean",
"description":"Indicates if there are more records beyond the current page.",
"example":false,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"totalResults":{
"type":"integer",
"description":"Total number of results matching the request.",
"format":"int32",
"example":100,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"count":{
"type":"integer",
"description":"Number of results returned in this response.",
"format":"int32",
"example":50,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"limit":{
"minimum":1,
"type":"integer",
"description":"Maximum number of items returned per page.",
"format":"int32",
"example":50,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"offset":{
"minimum":0,
"type":"integer",
"description":"Zero-based index of the first item returned.",
"format":"int32",
"example":0,
"xml":{
"namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
"attribute":true
}
},
"description":{
"type":"string",
"description":"Free text description of the file content.",
"example":"Clinical data extract",
"xml":{
"name":"Description",
"attribute":true
}
},
"fileType":{
"type":"string",
"description":"ODM file type that indicates whether the export is a full snapshot or a transactional change set.",
"example":"",
"xml":{
"name":"FileType",
"attribute":true
},
"enum":[
"SNAPSHOT",
"TRANSACTIONAL",
"Snapshot",
"Transactional"
]
},
"Granularity":{
"type":"string",
"description":"Granularity of ODM data export.",
"format":"string",
"example":"All",
"xml":{
"attribute":true
},
"enum":[
"ALL",
"METADATA",
"ADMIN_DATA",
"REFERENCE_DATA",
"ALL_CLINICAL_DATA",
"SINGLE_SITE",
"SINGLE_SUBJECT",
"All",
"Metadata",
"AdminData",
"ReferenceData",
"AllClinicalData",
"SingleSite",
"SingleSubject"
]
},
"archival":{
"type":"string",
"description":"Indicates archival state as per ODM YesOnly enumeration.",
"example":"Yes",
"xml":{
"name":"Archival",
"attribute":true
},
"enum":[
"YES"
]
},
"fileOID":{
"type":"string",
"description":"Unique file identifier.",
"example":"B1A2C3D4E5F647B18123456789ABCDEF",
"xml":{
"name":"FileOID",
"attribute":true
}
},
"creationDateTime":{
"type":"string",
"description":"Creation timestamp of the file.",
"format":"date-time",
"example":"2023-06-05T12:34:56Z",
"xml":{
"name":"CreationDateTime",
"attribute":true
}
},
"priorFileOID":{
"type":"string",
"description":"Identifier of the prior file related to this extract.",
"example":"C1D2E3F4A5B647B18123456789ABCDEF",
"xml":{
"name":"PriorFileOID",
"attribute":true
}
},
"asOfDateTime":{
"type":"string",
"description":"Timestamp indicating as-of datetime for the extract.",
"format":"date-time",
"example":"2023-06-05T12:34:56Z",
"xml":{
"name":"AsOfDateTime",
"attribute":true
}
},
"odmVersion":{
"type":"string",
"description":"ODM version used for the payload.",
"example":"1.3.2",
"xml":{
"name":"ODMVersion",
"attribute":true
}
},
"originator":{
"type":"string",
"description":"Originator of the data extract.",
"example":"Clinical One",
"xml":{
"name":"Originator",
"attribute":true
}
},
"sourceSystem":{
"type":"string",
"description":"Source system from which the data is generated.",
"example":"ClinicalOne",
"xml":{
"name":"SourceSystem",
"attribute":true
}
},
"sourceSystemVersion":{
"type":"string",
"description":"Version of the source system that generated the data.",
"example":"Clinical Data Unblinded API v11.0",
"xml":{
"name":"SourceSystemVersion",
"attribute":true
}
},
"id":{
"type":"string",
"description":"Unique identifier for the ODM document.",
"example":"EC942244BB30163BE053BEC44C64CF34",
"xml":{
"name":"ID",
"attribute":true
}
}
},
"description":"CDISC ODM v1.3.2 Clinical Data response with Clinical One specific extensions for v11.0. Contains pagination, filtering attributes and ClinicalData elements.",
"example":"\n\n\t\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t2025-10-29T13:31:11.301Z\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t2025-10-29T13:31:11.372Z\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t2025-10-29T13:43:28.354Z\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t2025-10-29T13:50:50.244Z\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:30:09.355Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:30:09.393Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:24.615Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:24.623Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:24.628Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:24.633Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:24.649Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:24.656Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:25.492Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:25.498Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.081Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.088Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.093Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.099Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.104Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.109Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.115Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.821Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:26.827Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:27.557Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:27.569Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t2025-10-29T13:43:27.575Z\n\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t